European Biotechnology Guide 2017

VOLUME 7

2017

7th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-62-2

European Biotechnology NET WORK

European Biotechnology Guide Science & Industry

© BIOCOM AG, Berlin 2017 European Biotechnology Science & Industry Guide 2017 (Volume 7) Published by:

BIOCOM AG Luetzowstrasse 33–36 10785 Berlin Germany Tel. +49-30-264921-0 Fax +49-30-264921-11 service@biocom.de www.biocom.de

Executive Producer: Andreas Macht Production Editor: Benjamin Röbig Graphic Design: Oliver-Sven Reblin Printed at: H. Heenemann GmbH, Berlin

This book is protected by copyright. All rights including those regarding translation, reprinting and reproduction reserved. No part of this book covered by the copyright hereon may be processed, reproduced, and proliferated in any form or by any means (graphic, electronic, or mechanical, including photocopying, recording, taping, or via information storage and retrieval systems, and the Internet).

ISBN: 978-3-928383-62-2

Editorial

Wake up and look at the role model biotechnology Welcome to the 7th edition of the European Biotechnology Science & Industry Guide, showcasing brilliant science and excellent business from companies, universities, research institutes, and expert support providers.

Brexit and Trump – two democratic “incidents” of last year are still dominating the headlines. Both have their roots in a severe loss of confidence in established political structures. What was almost unbelievable last spring, is shocking reality this year: the British will break away from their biggest market, and the new US president is a notorious liar who believes in nonsense rather than in scientifically proven facts.

With his sloppy immigration decree Trump showed that he is strong-willed to turn his confused political ideas into reality, ignoring the consequences for international cooperation. Especially science institutions and the high tech industry are used to and addicted to hiring the first-rate talents wherever they can find them on the globe.

In biotechnology in particular multinational cooperation is a must. I think it’s no overstatement to claim that biotechnology is one of the role models for international cooperation.

All stakeholders in the European biotechnology sector should wake up and remember that Europe as a strong community is perhaps not the only, but a substantial answer to the threats coming from Trump and other populists. All of us should be proud of our R&D structures and of course one of the biggest common markets of the world.

That’s something which is well worth to defend against rabble-rousers and brainwashers with their fake news.

The new, in fact multinational European guide is a good example for the internationality of the biotech sector. This treasure trove of science holds potential partners and brilliant ideas for your own work, so enjoy the read and make sure we are reading about you as well next year!

Brussels, March 2017 Andreas Mietzsch European Biotechnology Network www.european-biotechnology.net 7 th european biotechnology guide 2017

2|3

Content

Editorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

Analysis of European biotech companies on the stock markets.. . . .

7

Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information Processing Laboratory (IPL). . . . .

IRBM Science Park SpA. . . . . . . . . . . . . . . . .

IZB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 92 . . . . 94 . . . . 96

JPT Peptide Technologies GmbH. . . . . . . . . .

. . . . 98

Knowledge Transfer Network (KTN) . . . . . . . .

. . . . 100

3P Biopharmaceuticals S.L. . . . . . . . . . . . . . .

16 . . . . 16

ABZENA plc. . . . . . . . . . . . . . . . . . . . . . . . . . .

Acidophil Ltd. . . . . . . . . . . . . . . . . . . . . . . . . .

Advanced Targeting Systems . . . . . . . . . . . . .

AIT Austrian Institute of Technology GmbH. . .

ARTES Biotechnology GmbH. . . . . . . . . . . . .

Aston University . . . . . . . . . . . . . . . . . . . . . . .

Axxam S.p.A.. . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . .

18 20 22 24 26 28 30

LEITAT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Lonza Cologne GmbH. . . . . . . . . . . . . . . . . . .

. . . . 102 . . . . 104

M+W Central Europe GmbH. . . . . . . . . . . . . .

Medicines for Europe AISBL. . . . . . . . . . . . . .

Microsynth AG. . . . . . . . . . . . . . . . . . . . . . . . .

MOLOGEN AG . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 106 . . . . 108 . . . . 110 . . . . 112

Batavia Biosciences . . . . . . . . . . . . . . . . . . . .

Bayer AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Biaffin GmbH & Co KG . . . . . . . . . . . . . . . . . .

BioArctic AB . . . . . . . . . . . . . . . . . . . . . . . . . .

BIOCOM AG . . . . . . . . . . . . . . . . . . . . . . . . . .

Bioengineering AG. . . . . . . . . . . . . . . . . . . . .

BioMediTech. . . . . . . . . . . . . . . . . . . . . . . . . .

BIOTECON Diagnostics GmbH. . . . . . . . . . . .

BioVersys AG. . . . . . . . . . . . . . . . . . . . . . . . . .

BioWin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Boehringer Ingelheim . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32 34 36 38 40 42 44 46 48 50 52

NBE-Therapeutics Ltd.. . . . . . . . . . . . . . . . . .

Novaliq GmbH. . . . . . . . . . . . . . . . . . . . . . . . .

NSF Health Sciences Ltd.. . . . . . . . . . . . . . . .

. . . . 114 . . . . 116 . . . . 118

OPIS s.r.l.. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 120

Cambridge Cell Networks Ltd. . . . . . . . . . . . .

Campania Bioscience Scarl. . . . . . . . . . . . . .

CIBIO Centre for Integrative Biology. . . . . . . .

Cinfa Biotech S.L.. . . . . . . . . . . . . . . . . . . . . .

Clariant Produkte (Deutschland) GmbH . . . . .

CRS Clinical Research Services Andernach. .

. . . . . . . . . . . . . . . . . . . . . . . .

54 56 58 60 62 64

PharmaCell B.V.. . . . . . . . . . . . . . . . . . . . . . . . polpharma biologics . . . . . . . . . . . . . . . . . . . .

ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . .

ProDigest. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PROGEN Biotechnik GmbH . . . . . . . . . . . . . .

ProQinase GmbH . . . . . . . . . . . . . . . . . . . . . .

ProtATonce . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provecs Medical GmbH. . . . . . . . . . . . . . . . . .

. . . . 122 . . . . 124 . . . . 126 . . . . 128 . . . . 130 . . . . 132 . . . . 134 . . . . 136

Drooms GmbH . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 66

Recipharm OnTarget Chemistry . . . . . . . . . . .

Redx Pharma Ltd. . . . . . . . . . . . . . . . . . . . . . .

Rentschler Biotechnologie GmbH. . . . . . . . . .

Richter-Helm BioLogics. . . . . . . . . . . . . . . . . .

Roto Inox d.o.o.. . . . . . . . . . . . . . . . . . . . . . . .

. . . . 138 . . . . 140 . . . . 142 . . . . 144 . . . . 146

Enzymicals AG. . . . . . . . . . . . . . . . . . . . . . . .

Eurofins BioPharma Product Testing Munich.

EuropaBio. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Evotec AG. . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

SimplicityBio SA . . . . . . . . . . . . . . . . . . . . . . .

Swiss Biotech Association SBA . . . . . . . . . . .

. . . . 148 . . . . 150

TECOmedical AG . . . . . . . . . . . . . . . . . . . . . .

The Research Network (TRN) . . . . . . . . . . . . .

. . . . 152 . . . . 154

FILTROX AG . . . . . . . . . . . . . . . . . . . . . . . . . .

Fundaciรณn MEDINA. . . . . . . . . . . . . . . . . . . . .

. . . . 76 . . . . 78

Geneva Biotech. . . . . . . . . . . . . . . . . . . . . . . .

. . . . 80

UBMi/CPhI . . . . . . . . . . . . . . . . . . . . . . . . . . .

University of Birmingham . . . . . . . . . . . . . . . .

University of Copenhagen. . . . . . . . . . . . . . . .

University of Oxford. . . . . . . . . . . . . . . . . . . . .

. . . . 156 . . . . 158 . . . . 160 . . . . 162

HealthCapital Berlin-Brandenburg . . . . . . . . .

Heidelberg Pharma GmbH . . . . . . . . . . . . . . .

IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Infrapark Baselland AG. . . . . . . . . . . . . . . . . . intravacc. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

VAXIMM AG. . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 164

Xell AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . 166

68 70 72 74

82 84 86 88 90

7 th european biotechnology guide 2017

4|5

Analysis of European biotech companies on the stock markets: US vs Europe Executive summary After the record breaking numbers in 2015, biotech stock markets across the globe experienced a healthy reset in 2016. A dampened investor appetite is more visible on Nasdaq US than in Europe. This report highlights the key facts.

After a tsunami of biotech offerings crashed onto the stock markets during the past two years, the wave was inevitably quenched in a classic bear market situation. However, most experts believe that the more cautious IPO market represents a healthy reset and that the IPO window has not closed completely. Total numbers for 2016 demonstrate a steady stream of new biotech IPOs from European companies have taken place over the year.

Whereas the US investor appetite has dampened dramatically compared to recent years, we’ve continued to see a range of new biotech IPOs in Europe. Recently, there have been some positive signs that investors may be regaining some of their old appetite for these risky endeavours. This BIOCOM report analyses all of the European biotech firms listed on one of the 15 trading centres in Europe or on Nasdaq US. Taking all indicators into account – number and volumes of IPOs, follow-on financings and secondary listings – total proceeds of €3.3bn were raised by European biotech firms in 2016, a

Tab 1: K ey facts of European and US public biotech sector Europe Number of public biotech companies

US

213

3161/2

€ 106.14 bn

€ 781 bn1

Turnover (2013)

€ 14.02 bn

€ 85,15 bn1

Capital raised via IPOs (2009–2014)

€ 555.9 m

€ 1,264 m1/2

17

211/2

Market capitalisation

Numer of IPOs (2009–2014)

Source: 1 US companies on Nasdaq US; 2 BIOCOM research based on data provided by investships.com *Market cap on 30 Sep 2016

decrease of 48% compared to 2015. However, the figures were not as low as in 2012/2013 and remained at the comparably high level of 2014.

Nasdaq US plays minor role Unlike previous years, in 2016 Nasdaq US played only a minor role in raising funds for the European public biotech sector. The 29 companies that trade their shares on Nasdaq US raised combined total financial proceeds of €730m via IPOs and follow-on financings. This is 64% less than they succeeded in attracting in 2015 (€2.01bn) and represents only a small share of the total capital raised by European biotech companies (22%).

Europe more attractive in 2016 In 2016, a large majority of companies decided on a listing in Europe (14) in comparison to the US (3). Among the European trading centres, Paris and London, in particular, are the most attractive stock markets. In addition, six IPOs took place in Stockholm, and Frankfurt also saw its first biotech IPO since 2007.

Caution returns to stock market Following the record-breaking year 2015, the sector observed a decrease of biotech IPOs and follow-on financings in 2016. The figures are similar to those seen in 2014 and do not come close to the weak results in 2012/2013.

After the record financings for European biotech companies on the stock market in 2015, the sector is now observing significantly lower activity. According to the analysis, which also includes all European biotech firms listed on Nasdaq US, all of the key figures for 2016 show a signs of restraint. The 213 European biotech companies raised a total of €3.3bn of financial proceeds in 2016 – 48% less than in the previous year (€6.29bn).

IPO window remains open In 2016, a total of 17 European biotech IPOs took place, raising a total amount of €556m. This year shows a loss 7 th european biotechnology guide 2017

6|7

Fig. 1: Total financial proceedings of European biotech companies €6.29bn

€3.46bn

€3.30bn –48% +82%

Follow-on financings

© BIOCOM AG

2014

2015

The most attractive stock market locations are currently London (43) and Paris (42). However, Frankfurt (17) saw its first biotech IPO since 2007. The number of listed biotech companies in Sweden also increased significantly from 20 to 30, however four of the listings took place without financial proceeds. The shares of 29 European companies are currently traded on Nasdaq US and the latest US IPO of a European biotech company in 2016 was conducted by Swiss CRISPR Therapeutics (€51m).

2016

of 54% compared to the same period in 2015 (see Fig. 5). The majority of 14 firms opted for one of the 15 European trading centres, with three firms floating on Nasdaq US, instead. Compared to the previous year, investor appetite was lower and the sums attracted far smaller.

Whereas IPO volumes above €100m were not an exception in 2015, this year not a single European biotech company raised as much. Several firms even scrapped their deals or lowered their price ranges. The highest IPO volumes in 2016 were recorded with AC Immune (€59m) and Merus BV (€55m) on Nasdaq US and Celon Pharma in Warzaw (€57m).

Investors’ enthusiasm for biotech companies in 2015 could not be repeated in 2016. A total of €2.75bn was dropped into the companies via follow-on financings, a substantial decrease of 46% compared to the same period in 2015 (see Fig. 6). The average size of capital increase dropped from a record of €40m to a new low of €19m. Compared to 2014, however, the total of money raised via follow-on-financings was significantly higher (+24%). Within the European trading centres, Euronext showed the highest activity with 33 financings and total proceeds of €1,083m. A notable decrease was observed in the US. Only €565m came in through Nasdaq, a loss of 65% compared to the proceeding year (2015: €1.6bn).

Market cap The maturity of the European public biotech sector is growing. At the end of September 2016, the 210 European biotech companies had a joint market capitalisa-

Fig. 2: Distribution of market capitalisation of European biotech companies Large cap

1.4% (3)

Mid cap

4.3% (9)

Small cap

15.3% (32) 45.2% (95)

Micro cap Nano cap

33.8% (71)

0

10

20

30

40

50

60

70

80

90

100

tion of €106bn. 45% of the European biotech companies operate in the “micro” range between US-$50m and US-$300m (see Fig. 2). A further 34% ranks among nano caps (below US-$50m). Therefore, 79% of all companies have a market cap of less than US-$300m.

Only twelve companies have caps exceeding US-$2bn, these include the firms Actelion, Novozymes, Qiagen, Genmab and Eurofins. Compared to last year’s analysis, the companies in Europe were faced with generally less interest coming from investor and for this reason, they experienced a slight decrease in their overall market cap.

Fig. 3: Fields of activity Health/medicine (158 companies) Industrial biotechnology (20 companies) Agribiotechnology (1 company) Non-specific services (14 companies) 0.5 % 6.1 % 9.9 %

Oncology in the spotlight 83.5% © BIOCOM AG

The dominance of nano and micro cap companies in Europe also explain the comparatively low turnover. In 2015, European biotech firms generated a combined total turnover of €14.02bn (2014: €11.63bn). The vast majority of companies (84%) are active in the health sector, developing diagnostics or new therapies for which major investments and long-term financial strategies are required. Almost all of the 25 stock market newcomers in 2016 can be assigned to this category.

The most attractive field within the health area is oncology (see Fig. 4). A total of 76 companies operate in this

field, followed by neurology (36), inflammatory (31) and metabolic diseases (29) as well as autoimmune diseases (27).

Fig. 4: European biotech companies and the areas of indications* they address Autoimmune diseases

27

Cardiovascular diseases

18

Dermatology

6

Infections

25

Inflammatory diseases

31

Metabolic diseases

29

Neurology

36

Oncology

76

Respiratory diseases

12

Other

49 *Several mentions possible

© BIOCOM AG

7 th european biotechnology guide 2017

8|9

Fig. 5: Number of IPOs and the capital raised Initial public offerings: 2015

Total proceedings

Average volumes

Total number

€556m

17

€33m –54%

2014

€1,213m €49m

25

Fig. 6: Number of financing rounds and the capital raised Follow-on and other financings: 2015

Total proceedings

Average volumes

Total number

€2,746m

141

€19m –46%

2014

€5,080m €40m

Service providers that offer biotech-based processes for others in the B2B environment have a completely different risk profile than biopharma-focused companies. Although mid-cap companies such as bioMérieux and Eurofins fall into this category, only 13 companies overall operate in this field. Another area in which the listed companies are active is industrial biotechnology. A total of 21 firms are involved in the development of new enzyme-based processes or biobased solutions for various industries. German Brain AG has been among the newcomers in this field in 2016.

Exchange ranking With 15 different trading centres, the variety of stock exchanges is huge. The analysis of the last two years revealed that the cross-border stock market Euronext is especially attractive for European biotech companies as it clearly provides a critical mass of listed biotech companies as well as a nurturing environment in terms of

126

innovation and high-risk financing. This trend can also be confirmed for 2016. Four of this year’s 14 European listings (29%) took place here. Although the overall market conditions were not very attractive, some other locations were also able to increase their number of listed biotech companies. The highest number of debutants was recorded in Sweden. A total of 10 firms floated in Stockholm, among them Alligator Bioscience AB raising €49.3m, demonstrating that the stock market is gaining significance for biotech companies in Sweden. Another five companies chose the AIM in London for their debut, helping the LSE to regain the top position in terms of total biotech company numbers (see Fig. 7). Two British newcomers – Amryt Pharma and Salvarx Group – used the model of reverse mergers for their listing start.

No further records As forecast by analysts, this year’s overall stock market mood is less favourable for biotech IPOs than the previ-

ous two years. Compared to the record-breaking year of 2015, the number and volumes of IPOs as well as follow-on financings decreased (see Fig. 8 & 9). However, the levels are more comparable to the year 2014 and show that the decrease to date has not been as severe as in 2012 and 2013. It could be a sign that after record times and IPO booms, Europe is beginning to experience a more balanced stock market development.

Fig. 8: D evelopment of follow-on financings in €bn since 2011

591

total number

US market cooling off Biotech stocks have lost significant value in 2016 since an all-time high in recent years. That corresponds with a market currently slowing for initial public offerings of biotech companies and less activity on the part of investors.

The global public market upswing in the year 2014 was followed by an all-time high for biotech companies on the US stock markets and huge interest coming from European biotech firms in opting for a US listing. However, in 2015 the situation started to change and the biotech IPO boom began cooling off. In 2016, the situation deteriorated even further. Fears that the sector is experiencing a new crisis are unfounded. The overall activity of European biotech companies on the stock markets is comparable to the level seen in 2014.

2011

1.16

2012

1.23

2013

1.92

2014

2.21

2015

5.08

2016

2.74

€14.34 billion

Fig. 7: Overview of trading Centres with total numbers of European biotech companies 7

6

3

1

*Euronext, **Nasdaq Nordic

Helsinki **

Milan

Amsterdam *

Madrid

Copenhagen **

1

2016 Zurich

7

2016

2016 Frankfurt

1

8

Warsaw

2016 New York

1

8

Oslo

3

9

Brussels *

6 Stockholm ** 2016

11

2016

17

Paris *

21

3

2

213

30

2016

42

London

43

© BIOCOM

7 th european biotechnology guide 2017

10 | 11

Fig. 10: Comparison of capital raised via IPOs in €m and number of IPOs

2016

14

391.3

164.6

3

2015

406.6

2014

740.0

16 9 5 1 5

110.1 94.0

2012

21 4

506.9 59.4 47.0

2013

2011

806.2

1 7

17.7 0 European exchanges

0 NASDAQ

Greater market capitalisation That’s why, to date, there is still an interest of European biotech companies to go public in the US, but the environment is obviously not favourable for a high number of IPOs. In total, only 14% of the 213 listed companies trade their shares on Nasdaq US. The 29 companies have a combined market capitalisation of €22.11bn, which means an average of €850m. This is on average almost double (€457m) that of the firms listed in Europe only.

The lion’s share of the US-listed companies (50%) operate in the micro market capitalisation range between US-$50m and US-$300m, with a further 31% of the firms within a small cap range between US-$300m and US$2bn. Similar to their European-listed counterparts, there are only a few companies (11.5%) in the mid-market cap range between US-$2bn and US-$10bn. A big difference, however, is that in the US there are fewer companies in the nano market cap below US-$50m. This suggests that the US-listed companies have a slightly higher degree of maturity.

Dampened investor appetite The level of investor interest in biotechnology has been cooling off dramatically in 2016 compared to the boom year of 2015. In 2016, European biotech companies raised total financial proceeds of €730m via IPOs and

© BIOCOM AG

follow-on financings on Nasdaq US. This is 64% less than they succeeded in attracting in 2015 (€2.01bn), and represents only a small share of 22% of total capital raised

by European biotech companies in 2016.

Declining interest in IPOs In 2016, three European biotech companies raised a total of €165m via IPOs on Nasdaq US, demonstrating a decrease of 54% compared to 2015 (€407m). The companies Merus from the Netherlands, the Swiss AC Immune and Swiss CRISPR Therapeutics were able to price their shares at a lower level only, eventually raising €55m, €59m and €51m, respectively. However, average volumes were still great compared to those on European stock exchanges.

In 2016, the average on the US stock exchange amounted to €55m, almost double that of Europe an exchanges (€28m). In 2015, the gap was even wider between US (€101m) and European averages (€38m), when several companies attracted sums above €100m. The highest volumes of US IPOs in 2015 were raised by British Adaptimmune (€170m) and Danish Ascendis Pharma (€98m). In 2014, Danish Forward Pharma (€186m) and ProQR (€79m) from the Netherlands were at the top of the scale.

Follow-on financings US investor appetite decreased in 2016. The 29 companies attracted a combined total of €565m in follow-on

financings only, among them two secondary listings (Motif Bio, TiGenix). Compared to their counterparts which are listed on European stock exchanges only, the firms on Nasdaq US generated significantly less capital this year, but average volumes were nevertheless higher (US: €43m, Europe: €17m).

Drug developers go for Nasdaq US Drug developers, in particular, opt for a US listing, which is clearly connected with their high capital demand. The Nasdaq US newcomers in 2016 are active in the field of immuno-oncology (Merus), Alzheimer’s disease (AC Immune) and gene editing (CRISPR Therapeutics).

If you are interested to get the full version of the report for free, please visit: www.biocom.de/en/analysis2015 BIOCOM offers a broad spectrum of services to our clients from industry and the public sector: Customised consultancy services Surveys and market intelligence ECD data collections in biotechnology and life O sciences For more information, please visit: www.biocom.de/en/consultancy-and-research

Contact: Sandra Wirsching Divisional Director BIOCOM AG +49(0) 30-26 49 21-63 s.wirsching@biocom.de

7 th european biotechnology guide 2017

12 | 13

Europe’s No.

* 1

ZjgdeZVc"W^diZX]cdad\n#Xdb * For almost two decades, European Biotechnology has been the first and foremost information platform reporting on the life sciences in Europe. european-biotechnology.com is ranked No. 1 on Google.com, search terms biotechnology+europe.

Profiles

7 th european biotechnology guide 2017

14 | 15

Name · 3P Biopharmaceuticals

Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Email Website Number of Employees Founded (year) Areas of Activity

· · · · · ·

Pol. Mocholí. C/Mocholí 2.

31110 Noáin Spain Elena Erroba (Director of Business Development) +34-948-34-64-80 elenae@3pbio.com www.3pbio.com 160 2007 | Biotechnology | Biomedicine

Company profile 3P Biopharmaceuticals is a European-based contract development and manufacturing organisation (CDMO) specialised in the process development and GMP manufacturing of biopharmaceutical and cell therapy products.

Quality, flexibility and adaptation come together in a unique method of working. A highly qualified team accompanies clients through the full life cycle of their products as a robust manufacturing partner: from cell line development to clinical and commercial manufacturing.

3P has a successful track record on a global scale helping customers bringing their candidates from the early stages of development up to clinical phases and, ultimately, to commercialisation. In its state-of-the-art biomanufacturing facilities, the company also offers a comprehensive range of analytical and development services as well as continuous regulatory support that will improve the value of its client’s candidates.

GMP certified 3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained both mammalian and microbial expression system.

3P is GMP certified by AEMPS* for: ·· API manufacturing (clinical trials & commercial phase) ·· QC and release of API and Final Product for clinical trials and commercial phase * Spanish Medicines and Sanitary Products Agency (equivalent to EMA)

Summary services Biologics (New biological entities/biosimilar & bio betters) Development of Bioprocesses and GMP Manufacturing of: ·· Recombinant Proteins ·· Vaccines ·· mAbs ·· ADCs ·· Fabs

3P Biopharmaceuticals

Advanced therapies (Cell therapy) for non-GMP/GMP processes ·· Cell therapy products ·· Tissue engineered products ·· Cell culture media ·· Biomaterials (scaffolds or membranes) Manufacturing related services: ·· Generation of expression systems and cell lines ·· Process development ·· Bacterial, yeast capabilities (up to 1,000 L) ·· Mammalian capabilities (up to 2 x 200 L) ·· Analytics development/validation ·· Comparability Studies ·· Stability studies (preliminary, GMP, cell banks) ·· Cell bank manufacture, characterization and storage ·· Stability cameras: +25°C, +5°C, -20°C, -80°C ·· QA & Regulatory support

Facilities & equipment The company operates a 4,707 m² state-of-the-art manufacturing facility which is equipped with a microbial fermentation production suite, with a capacity of 10L, 100L and 1,000L and a mammalian cell culture system fully segregated with a current capacity of 50L and 2 x 200L. The facility has all of the necessary utilities required for bulk biologics manufacturing, including purified water, WFI, clean stream, nitrogen and compressed air. A 4,700 SF (436 m2) cGMP warehouse also supports the operation.

Track record 3P Biopharmaceuticals celebrates in 2017 its 10th Anniversary. Over these 10 years of international activity, 3P has been helping small biotech/start ups and large biopharmaceutical companies from all around the world with specific focus in Europe and USA. 3P has been involved in GMP manufacturing projects starting from gene design up to clinical phase manufacturing and others involving Technology Transfer from several CMO s based in Europe, United States, Argentina and Australia and targeting late stage GMP manufacturing.

7 th european biotechnology guide 2017

16 | 17

Name · Abzena

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Babraham Research Campus, CB22 3AT, Babraham, Cambridge United Kingdom Sven Lee +44-1223903498 info@abzena.com www.abzena.com

LI 180 2014 | Immunogenicity assessment of proteins | Creation of fully deimmunised antibodies and proteins | Manufacturing cell line development | Antibody drug conjugate development and optimisation of pharmacokinetics | GMP manufacturing | Chemistry research

Abzena provides a suite of complementary services and technologies to R&D organisations to select and create better therapeutics with less risk of failure in clinical development.

Abzena has undergone a significant transformation in the past few years following the acquisition of Antitope in 2013 along with PacificGMP and TCRS in 2015.

Bringing together these companies allows Abzena to support customers’ projects seamlessly from lead optimisation and selection through to GMP manufacturing for clinical trials.

Services and technologies Immunogenicity assessment EpiScreen™ is an accurate and sensitive way to assess the potential immunogenicity of proteins and antibodies ex vivo by measuring CD4+ T cell responses, the primary drivers of memory-based immunogenicity. This method has been used across the industry to assess risk at the preclinical stage. Abzena also provides rapid high-throughput in silico analysis of MHC class II binding and T cell epitope location with iTOPE™ and TCED™.

Antibody humanisation and protein deimmunisation Composite Human Antibody™ and Composite Protein™ services are used to create biopharmaceuticals devoid of the T cell epitopes that lead to an adverse immune response while minimising the loss of antibody affinity or protein activity that can occur with standard protein engineering techniques.

Cell line development High-expressing mammalian cell lines are developed for the production of specific partner antibodies and proteins, including biosimilars, using Composite CHO™, NS0, Sp2/0 or other cell lines. Cell lines suitable for commercial manufacture can be transferred to Abzena’s own manufacturing facility or directly to your preferred GMP contract manufacturing organisation.

Abzena

Antibody drug conjugates Abzena has developed its range of novel ThioBridge™ linkers to efficiently conjugate drugs to antibodies to create less heterogeneous ADCs with better stability.

The proprietary technology uses site-specific conjugation to naturally occurring inter-chain disulfides avoiding the need for antibody re-engineering. Abzena also have a comprehensive toolbox of payloads and other linker technologies to support ADC projects.

Optimisation of pharmacokinetics Abzena’s proprietary PEGylation technologies enable polyethylene glycol (PEG) or other polymers to be conjugated to specific sites to extend the in vivo half-life of therapeutic proteins. TheraPEG™ conjugates PEG at disulfide bonds, HiPEG™ to poly-histidine motifs and CyPEG™ to a thiol on a free cysteine. Abzena has conjugated both linear and branched PEG to a variety of therapeutic proteins.

GMP biologics manufacturing Abzena provides cGMP production for recombinant proteins, antibodies, gene therapy products and vaccines for use in preclinical and phase I and II clinical trials. Abzena has extensive experience in the use of single-use technology which provides flexibility in the production process.

Chemistry research and manufacturing Abzena also provides comprehensive chemistry services to pharmaceutical, biotech and agrochemical companies as well as governmental and academic research institutes. The company has a strong background in synthetic organic chemistry and expertise in bioconjugation, including production and manufacture of antibody-drug conjugates.

Working with us Abzena offers a range of services and technologies to help you develop better antibodies, proteins and small molecules. We have over ten years of experience working with R&D scientists in a flexible and collaborative manner to reach project objectives.

7 th european biotechnology guide 2017

18 | 19

Name · Acidophil Ltd.

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

20 Station Road Suite 103 CB1 2JD Cambridge United Kingdom Dr Simon Aspland +44-1223-803827 info@acidophil.com www.acidophil.com

I 5 2012 Virtual Creation, management, and investment in innovative biotechnology products and companies to serve unmet needs in agriculture and health

External · Isomerase Therapeutics Collaborations Request for · Yes Further Collaborations

Acidophil is an innovation company that semi-serially develops, creates, manages, and invests in innovative biotechnology businesses. Acidophil Ltd is the UK affiliate of US-based Acidophil LLC. Acidophil was founded by the Nobel Laureate Dr Sydney Brenner and Dr Philip Goelet.

Acidophil works on unmet market needs in the areas of human health, animal health, and agriculture, including crops, through combinations of synthetic biology, synthetic chemistry, biotransformation, and biochemistry.

Our work is carried out using a virtual business model.

Intellectual property is invented by Acidophil and its network of consultants and collaborators. Inventions are reduced to practice at a combination of dedicated labs and technology partners and through work at contract research organisations. Companies co-founded

by Acidophil include Population Genetics Technologies, Ltd.(technologies to augment next generation sequencing), Arginetix, Inc. (therapies for endothelial disorders), ZuvaChem, LLC (renewable sources of feedstock for speciality chemicals), and AgriMetis, LLC (see below).

As an illustrative example, Acidophil co-founded and co-invested in AgriMetis in 2014 with Syngenta Ventures.

Acidophil then provided management to AgriMetis under contract throughout AgriMetis‘ Series A. AgriMetis‘ program to discover, develop, and deliver innovative, sustainable crop protection agents was supported by bridge financing from Acidophil, then with $10MM in Series A financing from a syndicate of investors, and more recently with $23.5m in Series B financing.

Acidophil

Acidophil is now preparing to launch a new animal health venture in 2017. Acidophil is interested in the following areas for collaboration: ·· Market research, financial valuation, and competitive intelligence ·· Synthetic biology, chemistry, fermentation, and biotransformation ·· Intellectual property analysis, innovation, patent protection, and licensing ·· Strategic partnering & licensing ·· Investment in opportunities that we are currently developing on For more information, please visit our website (www. acidophil.com) or contact us directly at info@acidophil. com.

7 th european biotechnology guide 2017

20 | 21

Name · Advanced Targeting Systems, Inc.

Address/P.O. Box · 10451 Roselle St, Ste 300 Postal Code/City · 92121 San Diego CA Country · United States European office: Joure, Netherlands Contact Person · Denise Higgins Telephone · +1-858-642-1988 Fax · +1-858-642-1989 Email Address · europe@atsbio.com Internet Website · www.ATSbio.com Social Media · L I Number of Employees · 9 Founded (year) · 1994 Type of Laboratory · Research supplies Areas of Activity · l Neuroscience l Oncology l Immunology l Biology l Biotechnology l Pharmaceutical l Drug development

Advanced Targeting Systems (ATS) is a San Diegobased biotechnology company dedicated to providing quality targeting reagents for scientific research and pharmaceutical development. ATS has an office in Europe and works with distributors throughout the rest of the world.

Targeting tools for research and drug development ATS is known as the “saporin people” and initially focused on providing research tools for the Neuroscience research community. Over the years these tools have been used in all areas of scientific research and drug development. The current product line includes targeted toxins, antibodies and custom services designed to assist scientists in the study of system functions, cell functionality, diseases and disorders.

Targeting tools include a ‘Knockout’ technology Advanced Targeting Systems pioneered the use of targeted conjugates for use in a technique called “Molecular Surgery.” These products include specific lesioning agents that permanently eliminate cells.

Targeted toxins offer the ability to develop “knockouts” through cell surface-based targeting that has several advantages over the gene-based approach. The “knockout” has a slight but important difference: instead of knocking out a particular protein from a set of cells (or even the whole animal), a particular cell type is eliminated. About 3–4 days after treatment, behavioral differences begin to show which usually become permanent after a week or so.

A targeting agent is conjugated to a payload. Here the conjugate is an antibody linked to a small molecule.

Advanced Targeting systems

In addition, ATS sells “secondary conjugates� which allow users to convert their own targeting agents into specific cytotoxic tools and to screen antibodies for internalisation.

Targeting tools you make yourself The targeted conjugate binds only cells specific to the antibody.

Binding causes the receptor to internalise the conjugate.

The internalised conjugate is digested by enzymes and the payload is released into the cytosol. It is then free to alter the cell.

ZAP (non-targeted saporin) products produced by ATS allow a large number of targeting agents to be screened quickly and cost-efficiently for specificity, functional binding, internalisation, and EC 50 determination. The wide selection of these secondary conjugates provide ideal tools for screening potential targeting agents. They are constructed using either species-specific polyclonal anti-IgG antibodies, or streptavidin (for use with biotinylated targeting agents), that are chemically attached to Saporin, the most potent of the plant ribosomeinactivating proteins. The ZAP product is simply mixed with the targeting candidate, and added to cells. This complex is bound by the targeted cells, internalised, and the Saporin protein is released within the cytosol to inactivate the ribosomes. Cells not expressing the target do not bind or internalise the ZAP-targeting agent complex, and are not affected. Saporin has no binding chain, and no means of getting into cells on its own.

Advanced Targeting Systems provides innovative, cutting-edge tools to accelerate and optimise research.

Scientists around the world have published exciting new data to advance knowledge of how specific cell types affect behavior and disease. With each new discovery, possibilities move closer to realities for unraveling the molecular basis for behavioral abnormalities and cures for devastating diseases.

7 th european biotechnology guide 2017

22 | 23

Name · AIT Austrian Institute of Technology

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · ·

Donau City Strasse 1 1220 Vienna Austria Dr Martin Weber +43-50550-4420 martin.weber@ait.ac.at www.ait.ac.at 1,260 2009 | Molecular biology laboratories | Chemistry laboratories | Physics laboratories | Clean room laboratories for thin film technologies Areas of Activity · | Molecular diagnostics | Biomarker research and development | Biosensor development | Bioinformatics | POC systems | Systems integration Total Revenue · € 131 m External · National and international clinical and Collaborations academics, e.g. | Imperial College London | Medical University Vienna | Medical University Graz National and international industry, e.g. | Abcodia | Biovendor | Scienion | Greiner BioOne | Oasis Diagnostics

Non-invasive molecular diagnostics Among the European research institutes, the AIT Austrian Institute of Technology, Austria’s largest nonuniversity research institute, is a specialist in the key infrastructure issues of the future. As an ingenious partner to industry and public institutions, AIT experts provide research and technologies to realise fundamental innovations in the fields of health & bioresources, environment, energy, mobility and digital safety & security.

The business unit molecular diagnostics focuses on minimally or non-invasive molecular diagnostics using body fluids.

Discovery and validation of new biomarkers, assay development, bioinformatics, diagnostic biosensors and innovative point-of-care systems are major core competencies. In the field of biomarkers, the two focus areas are methylated cfDNA based biomarkers and autoantibody-based biomarkers in serum, plasma and saliva. Indications range from cancer to lung diseases, diabetes and autoimmune disorders.

Autoantibody-based biomarkers for cancerous diseases are based on the following: cancer onset and progression produces aberrantly expressed proteins generally also termed as tumour-associated antigens (TAAs), which are able to evoke an immune response, resulting in the production of autoantibodies. These autoantibody can be detected months or years before the clinical diagnosis of cancer, thus, serving as biomarkers for the early diagnosis.

Saliva as a diagnostic medium A main research area is saliva diangostics. “As molecular methods have become increasingly sensitive, much information can nowadays be gained from saliva instead of blood analysis,” explains Dr Martin Weber, head of molecular diagnostics at AIT. Saliva contains nucleic acids and proteins, which can be used not only to distinguish between bacterial and viral infections but also to identify the presence of cancer, Alzheimer’s, Parkinson’s and cardiovascular disease at an early stage.

AUstrian institutE of technology

A major advantage is the non-invasive nature of this method: blood samples are no longer required, reducing the risk of infection.

AIT offers the following technical competencies and solutions to academic and industrial partners:

Sensor development AIT develops highly sensitive optical, magnetic and electrochemical biosensors for the analysis of liquids such as blood or saliva for different applications.

Biomarker development Biomarkers allow early diagnosis and therapy monitoring of complex diseases. The focus is on nucleic acid and protein-based biomarkers and biomarker screenings.

Additional services: ·· biomarker discovery ·· development of (multiplexed nucleic acid and autoantibody) assays to confirm and validate biomarkers for diagnostics

Assay development Development and validation of diagnostic assays as well as development of QC procedures for DNA, RNA and immunoassays.

Bioinformatics We support customers’ NGS projects and optimise methods of classification/pattern recognition in terms of diagnostic application to molecular biological data.

© Bernhard Rothkappel

Lab-on-a-chip and system integration AIT experts have extensive expertise in the integration of biomarkers, sensors, microfluidics, molecular detection reactions and readout electronics. System integration aims to achieve optimal interaction between the individual components, while also providing a simple and user-friendly overall system.

7 th european biotechnology guide 2017

24 | 25

Name · ARTES Biotechnology GmbH

Address/P.O. Box Postal Code/City State Contact Person

· · · ·

Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · ·

Elisabeth-Selbert-Straße 9 40764 Langenfeld Germany Dr Melanie Piontek (Business Development Director) +49-2173-27587-12 +49-2173-27587-77 info@artes-biotechnology.com www.artes-biotechnology.com 24 2002 S1 Development and technology transfer of biopharmaceutical production processes

Biological Patents · Patents and exclusive Licenses on: | Hansenula yeast expression platform | VLP based vaccine technology (METAVAX®) | Enhanced secretion via Chaperones | Fermentation processes | Protein isolation External · Co-developments: amatsiQBiologicals, Collaborations instrAction GmbH, PAC, (Peschek Analytic Consulting), Burnet Institute, PATH Request for · Customer excerpt: Johnson&Johnson, Further Collaborations PT Bio Farma, Boehringer Ingelheim Vetmedica GmbH, DuPont, Minapharm Biogenetics, Cadila Pharmaceuticals, Sun Pharmaceutical R&D collaboration and strategic partnerships with biopharmaceutical companies.

ARTES Biotechnology ARTES Biotechnology is a globally active R&D company, specialised in developing biopharmaceutical production processes.

Since 2002, ARTES has positioned itself as a valued partner for the pharmaceutical industry with several technology transfers successfully implemented worldwide at our partners’ sites.

Today, ARTES is a strong, well-established partner for the development of customer driven projects up to supply of pre-clinical material. In addition, we are developing own VLP based vaccine candidates up to proof-ofconcept in animals. ARTES is actively looking for partnerships to identify and to create new opportunities, especially in vaccine research as well as for out-licensing its own developments.

Process development and technology transfer Biopharmaceutical process development at ARTES typically starts with the generation of high yield production cell lines based on our proprietary microbial expression platforms Hansenula polymorpha and E. coli.

Up- and downstream process development is performed at lab and pilot scale. Fermentation processes are designed to ensure low-cost manufacturing with optimal productivity from fully synthetic media, avoiding expensive additives and extended fermentation times.

The purification process of the product aims at high titers of purified Active Pharmaceutical Ingredient (API).

Gram amounts of highly purified API for pre-clinical testing can be delivered from ARTES’ pilot plant.

By providing the full set of the documentation of biopharmaceutical process development and of the manufacturing of the pre-clinical material, ARTES ensures the smooth and direct transfer into large scale cGMP manufacturing. Arms-length assistance is available for the transfer of the process to the CMO or client´s plant.

ARTES has developed biopharmaceutical processes available for out-licensing, including bio-similar therapeutics such as interferon-alpha and hirudin, as well as vaccines such as HepB, and continues to expand this portfolio.

ARTES

Vaccine development platform (METAVAX® Technology) New vaccine candidates are developed based on our chimeric duckHepB virus like par ticle plat form METAVAX®. This technology platform is best suited for the development of highly immunogenic vaccines in human and animal health.

Vaccines build on our METAVA X ® Technology and manufactured in the WHO recommended, stable yeast platform Hansenula polymorpha build an economical approach to low-cost mass production of safe, effective and self-adjuvanting vaccines. We obtain chimeric VLPs using stable co-expression of multiple different genes in one and the same production cell line.

Currently, our METAVAX® Technology is applied in several client projects and in own developments of adjuvant-free vaccines. Internal R&D at ARTES focuses at present on veterinary (Classical Swine Fever, Bovine Viral Diarrhoe, West Nile Virus, Feline Leukemia Virus) and human vaccines (Malaria, Hepatitis C, Flu).

Partnerships and networking ARTES builds alliances with well renowned academic institutes and pharmaceutical companies around the world. We are involved in funded R&D projects (EuroTransBio, PATH Malaria Vaccine Initiative), collaborative research and in contract R&D projects.

Our key expertise is on development candidates and production processes based on yeast for recombinant sub-unit vaccines presented as highly immunogenic virus-like-particles. The METAVAX® Technology is a highly competitive platform for the development of vaccines for both human and veterinary applications.

Together with a network of collaboration partners (e.g. the Australian Burnet Institute, amatsiQBiologicals) ARTES offers the full range of competencies from cell line and process development, manufacturing and testing of preclinical samples and up-scaling/cGMP manufacturing.

ARTES is open to discuss individual business models, including fee-for-service contract R&D, milestone based collaboration (shared risk/shared benefit) and co-development.

7 th european biotechnology Guide 2017

26 | 27

Name · Aston University

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · ·

Aston Triangle B4 7ET, Birmingham United Kingdom Roslyn Bill +44-121-204-4274 r.m.bill@aston.ac.uk www.aston.ac.uk 1,393 1966 Academic Life and health and medical sciences, engineering and applied sciences

Annual Income · £ 150m in 2015/2016 Research Awards · £ 22m in 2015/16 Biological Patents · 92 External · Extensive Collaborations Request for · Yes Further Collaborations

Aston University is based in Birmingham – the UK’s second largest city – and has a long history of applying scientific research to real-world problems. The University grew out of the Birmingham Municipal Technical School, opened in 1895, which addressed a growing need to enhance Britain’s manufacturing industry with practical discoveries in science and technology. In the years after World War II, the burgeoning School (now a College of Advanced Technology) emerged as a leader in technical education. In 1966, it received a Royal Charter and officially became Aston University; to this day it maintains a reputation for high-quality research that brings direct benefits to the people and businesses of the UK and beyond.

Biotechnology is a thriving research area at Aston where academics work across a range of different, but related, disciplines. The University currently offers Biotechnology modules (in industrial food microbiology and gene therapy) within its BSc programmes, as well as an MSc in Molecular Biotechnology (covering enzyme biotechnology, recombinant protein biotechnology, stem cells, tissue engineering and drug discovery).

Overall, there is a focus on industrially-relevant biotechnology with academics also working in connected areas, such as biomaterials, informatics, pharmaceutics and immunology.

Molecular biotechnology

Member of

European Biotechnology NET WORK

Professor Roslyn Bill’s team focuses on making proteins for use as therapeutics (hormones, vaccines or antibodies, for example) or as templates for the development of new drugs (primarily membrane proteins). They develop yeast cells as “factories” to synthesise these proteins for further research and development. They focus on industrially-relevant proteins such as the aquaporin and G protein-coupled receptor (GPCR ) families.

Aquaporins regulate water balance in the human body and therefore have potential for the development of drugs to treat brain oedema, while 25 per cent of the top-selling drugs and 40–50 per cent of all clinically prescribed drugs currently target GPCRs. Professor Bill’s colleague, Dr Anna Hine works on ways in which proteins can be engineered to improve their properties. She was the 2013 winner of the prestigious Biotechnology and Biological

aston university

Sciences Research Council’s Commercial Innovator of the Year Award in recognition of her development of highquality gene libraries for use by the biotechnology and pharmaceutical industries now marketed as ColibraTM.

Industrial biotechnology Professor Christopher Hewitt’s team are experts in bioprocessing with a focus on scaling-up industrially important processes from the laboratory bench for direct industrial application. As bioprocess engineers, they develop scalable manufacturing technologies and processes for products including protein biopharmaceuticals, cell therapies and biofuels. These products are manufactured via traditional biotechnology as well as synthetic biology approaches. Dr Alan Goddard’s research focuses on protective changes that cells undergo to survive the often challenging conditions encountered in biotechnological processes. He works to identify fundamental biochemical and biophysical characteristics of the strains that can then be altered using synthetic biology approaches to enhance bioprocesses. The industrial biotechnology team runs projects in microbial fermentation, bio-remediation, bio-transformation, regenerative medicine bioprocessing and cell culture and has a strong record in industrial collaboration.

Biotechnology of healthcare-associated infections Within the EU, over four million patients contract a hospital-acquired infection each year, which accounts for an estimated 37,000 deaths, while costing the UK National Health Service alone over £1 billion annually.

Research carried out by Professor Anthony Hilton, Dr Tony Worthington and Professor Peter Lambert at Aston University has revealed that a much higher number of common pathogens were significantly reduced by copper than by other materials. As a result, Aston has been a partner in global clinical trials, where a range of products in hospitals – such as grab rails, door handles and light switches – have been replaced with copper surfaces. The latest data show that patients in intensive-care units fitted with antimicrobial copper surfaces have a 40 per cent lower risk of acquiring a healthcare-associated infection than those in rooms using other metals.

7 th european biotechnology guide 2017

28 | 29

Name · AXXAM

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Via Meucci 3 20091 Bresso (MI) Italy Lia Scarabottolo +39-022105621 +39-022105602 lia.scarabottolo.ls@axxam.com www.Axxam.com

I

80 2001 Molecular and Cellular BiologyBiochemistry-Electrophysiology Areas of Activity · Pharmaceutical Nutraceutical Agrochemical Cosmetics

Biological Patents · | EP1413584 WO2004/035620 | EP1858921 WO2006/094805 | EP1606622 WO2004/083803 | EP1664102 WO2005/035559

Discovery platform

External · | IMAX Collaborations | HDC | Mercachem | CD3 | INS

Member of

AXXAM S.p.A. is a privately owned innovative Partner Research Organisation (iPRO) and discovery company with a team of 80 highly skilled employees, most of them experienced scientists, located at OpenZone Science Park, Bresso (Milan, Italy). Since its inception in 2001, as a spin-out from the Bayer Group, Axxam has built up an integrated discovery platform called “Lead Engine”, which consists of “assay development”, “high throughput screening”, “hit follow-up” and “medicinal chemistry” modules. This streamlined industrial platform is used for the discovery of novel bioactive compounds and as such, is at the basis of discovery services provided by Axxam’s fully dedicated services unit. The company has developed a multi-year proven track record as a third party research and discovery services provider for the life science industry. Axxam has collaborated with more than 50 international partners, ranging from small biotechs to big pharma, agrochemical, fragrance and flavour companies, and a growing network of research institutions. In the last few years, Axxam has expanded its business model, by establishing its own suite of internal discovery programmes against attractive biomedical targets, which are then out-licensed at the lead candidate stage to a collaborative/licensing partner.

European Biotechnology NET WORK

Axxam’s discovery platform refers to a fully integrated drug discovery process ranging from target identification to generation of “qualified hits”. Axxam has proven expertise in assay development for the most relevant target classes of the life sciences industry, with specific focus on GPCRs, ion channels, but also transporters, ion exchangers, tyrosine kinase and cytokine receptors, nuclear hormone receptors, proteases, kinases and transferases. The company has set up an industrialised process for assay development which has produced high throughput screening assays for over 250 key drug targets. Recently, Axxam also successfully implemented the innovative technologies of gene editing nucleases and optogenetics tools, for the development of smarter “next generation” cellular assays. Axxam operates with highly customised state-of-the-art high throughput screening stations designed to run biochemical and cell-based assays. The screening stations

A xxam

are able to generate more than 50,000 test points per day. Axxam has implemented a comprehensive “hit follow-up” platform that maximises the results from a primary screening campaign. Activities include: hit confirmation; orthogonal assay testing, determination of relative potencies through dose-response assays, selectivity and proof of concept assays. The screening campaigns can be conducted using either the customer’s library provided or Axxam’s compound collection AXXDIV2.0, a new 240,000 compounds library characterised by a high level of diversity and novelty. Axxam has also an electrophysiology unit equipped with both manual and automated patch-clamp devices.

Laboratories and offices Axxam laboratories and offices cover an area of more than 1,800 m2, with modern and very functional furniture and services. At this site, Axxam has state-of-the-art-inhouse equipment for molecular biology, cell handling and for cell based and biochemical assay development, including: FPLC, fluorescence readers, sonicators, electroporators, thermocyclers, automated well dispensers, FLIPRTETRA readers, fluorescence microscopes, manual and automated (QPatch 16X) patch clamp devices, laminar benches and incubators; and two integrated screening stations, including CyBi® pipetting platforms for fully automated single- to multichannel liquid handling, fluorescence and luminescence FLIPR TETRA readers, BMG-Pherastar and Envision-PerkinElmer readers, plate sealer and peeler, automated plate washers, and Hamilton Starlet for versatile cheery-picking. Recently, Axxam acquired an automated compound storage. Axxam has also implemented the GeneData software for HTS analysis and software for chemoinformatic analysis and has created a proprietary data base for data storage and mining. Axxam has also implemented a HCS microscopy platform comprises an Operetta CLS system, which can process 384 well/microtiter plates, and has set up a laboratory dedicated to the development of biological radioactive assays and radioactive screening of compounds. The medicinal chemistry laboratories, fully dedicated to internal research projects, are equipped with all the instrumentation and software needed for modern synthetic organic chemistry and analytical chemistry.

7 th european biotechnology guide 2017

30 | 31

Name · Batavia Biosciences

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Zernikedreef 16 2333 CL Leiden The Netherlands v.franssen@bataviabiosciences.com +31-889950600 Info@bataviabiosciences.com www.bataviabiosciences.com

LI 95 2010 R&D, BSL-2/2+, GMP Preclinical biopharmaceutical development services and technologies l Cell line generation l Upstream process development l Purification development l Product characterisation l Assay development l Cell & virus banking l Stability studies l cGMP manufacturing l Consultancy

External · Collaborations with pharmaceutical Collaborations and biotechnology industry, academic and government institutions and charity organisations.

Request for · Interested in partnerships and consorFurther Collaborations tia to develop new technologies.

About Batavia Biosciences Batavia Biosciences is a biotechnology company with the mission to significantly contribute to ease human suffering from disease by improving the success rate in the translation of candidate medicines from discovery to the clinic.

Hereto, the company offers services and has developed a portfolio of technologies aimed to improve product yield, reduce process development time and increase product stability. These technologies have amply demonstrated to improve speed and reduce cost in biopharmaceutical development, accelerating the journey from bench to clinic.

Services Batavia Biosciences offers end to end services for large and small pharmaceutical companies, biotechnology companies, academia and non-profit organizations. Our services include viral vector and protein expression vector construction, generation of viral vaccine seed stocks, mammalian cell line and microbial strain generation, transient protein production, upstream and downstream process optimisation, medium development, assay development, product characterization and clinical manufacturing.

Technologies STEP® technology increases protein expression in CHO cells with at least 10-fold, taking a mere 14 weeks to generate stable cell clones. STEP® is a novel plasmid based expression platform. By means of a highly stringent selection our platform achieves extreme high protein expression levels in CHO cells without the need for gene amplification or time-consuming rounds of cell sub cloning.

The SCOUT® platform integrates scaled down, high throughput cell culture systems with high throughput purification and analytical capabilities. In combination with a comprehensive Design of Experiments (DoE) approach, we can rapidly generate functional product data, accelerating candidate selection and driving efficient process optimization. Rapid product quality analysis for example allows clone selection not only

Batavia biosciences

based on yield but also on product quality attributes such as glycosylation, aggregation and potency.

The SIDUS ® technology platform originates from our in-depth experience and complete protocol system concerning the manufacture of viral vectors for vaccines or gene therapy.

Experts Batavia Biosciences employs a highly educated staff with many years of experience in DNA cloning, mammalian cell line generation, upstream process development (mammalian, microbial & insect cell platforms), purification development, product characterization, and clinical manufacturing. As such the company is well positioned to take on any challenge associated with the development of complex biological medicines be it proteins, antibodies, vaccines or viral vectors.

Quality The Quality assurance team at Batavia Biosciences has ample track record in supporting successful IND and IMPD programs. The team works closely with its sponsors to ensure that the appropriate documentation is delivered in a timely manner according to the requirements defined in a Quality Agreement. The Batavia Biosciences QA and QC department is intimately involved in the release of your product. Batavia Biosciences has successfully supported a number of IND’s and IMPD’s covering diverse biopharmaceuticals both novel as well as biosimilar products.

Worldwide presence Batavia Biosciences was fully operational in Leiden, the Netherlands in January 2010. In 2012 we launched our US subsidiary in Woburn, MA. In 2015 the company opened an office in Hong Kong to serve the growing order portfolio in Asia.

In Woburn and Leiden, Batavia Biosciences currently occupies 27,500ft 2 of BSL-2 R&D facilities with dedicated mammalian and microbial vaccine and protein suites up to 100L production capacity.

Batavia Biosciences also offers a fully equipped BSL-2 GMP facility up to 200L scale.

7 th european biotechnology guide 2017

32 | 33

Name · Bayer AG Pharmaceuticals Biological Development Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Friedrich-Ebert-Str. 217 42096 Wuppertal Germany Dr Felix Oehme +49-202-36-7743 felix.oehme@bayer.com www.bayer.com

Company profile Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture.

Its products and services are designed to benefit people and improve their quality of life. To achieve this, in Pharmaceuticals we concentrate on the research and development of innovative drugs and novel therapeutic approaches, while at the same time, we are constantly improving established products. In this context, Bayer uses experience it has gained from the last 150 years in the business.

FL I  approx. 39,000 worldwide 1863 in Wuppertal, Germany Biological Development: S1 Focus on improving human health

Annual Turnover · €16,420 million in 2016 Relevant R&D Budget · €2,787 million in 2016 External · Contract development of biotechnologCollaborations ical processes from lab to large scale, and contract production of active ingredients, pharmaceutical intermediates, and biocatalysts.

Biotech development Bayer has more than 125 years of experience in developing and producing pharmaceuticals. An integral part of this expertise is the development of biotech products such as recombinant proteins and monoclonal antibodies, which we have successfully pursued for over 20 years. Today our well-established know-how together with our excellent infrastructure open up new opportunities in the area of modern industrial biopharmaceuticals. Our Biological Development center in Wuppertal is well established as a center of excellence for highly efficient biotech development and manufacturing. This includes some 10 years of experience in contract manufacturing. Overall, we have produced more than 200 target proteins for research, as well as more than 20 proteins under cGMP for diagnostic and therapeutic use. 120 highly trained employees at Biological Development in Wuppertal operate state-of-the-art laboratories for process development, as well as state of-the-art GMP facilities for microbial and cell culture technology.

Integration into the Bayer QA/QC system ensures strict compliance to cGMP regulations. Furthermore, you can take advantage of our high safety and environmental standards (ISO 14001).

Bayer

Microbial technologies Microbial cGMP fermentation is performed in a large multipurpose pilot plant using completely closed systems during fermentation up to the 3,000 l scale. The facility is registered for use of GMO on biosafety level 1.

Cell culture-based technologies The mammalian cell culture GMP plants offer the perfect environment for the production of monoclonal antibodies (grams to kilograms) under cGMP conditions. The capacity of the fermentation suites are up to 3,000 l fermenter for fed-batch and up to 200 l for continuous perfusion operation. Harvest processing of 500 to 1,000 l per day in case of continuous perfusion yielding several kilograms per fermenter unit per year, can be handled.

At a glance ·· Experienced multidisciplinary team ·· Licensed GMP facilities ·· Highly innovative microbial and mammalian cell culture technology ·· Downstream processing to bulk ·· Broad array of biomolecule analytics

Products ·· T herapeutic proteins and monoclonal antibodies manufactured under cGMP ·· Glycosylated and complex proteins ·· Diagnostic proteins ·· Research proteins ·· Biocatalysts

7 th European biotechnology guide 2017

34 | 35

Name · Biaffin GmbH & Co KG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website

· · · · · · · ·

AVZ 2, Heinrich-Plett-Str. 40 34132 Kassel Germany Dr Bastian Zimmermann +49-561-8044668 +49 561-8044665 info@biaffin.com www.biaffin.com www.proteinkinase.biz

Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · ·

FIQ 8 2001 Analytical, ISO 9001:2015 certified Service provider for biomolecular interaction analysis and enzymatic assays, supplier of recombinant proteins and reagents for kinase research and signal transduction

External · Collaborations with academic research Collaborations groups and industrial partners in EU funded projects Request for · Biaffin is generally interested in Further Collaborations joining publicly funded research projects and serves as a supplier for contract research for scientific institutions and industrial partners

Company overview Biaffin GmbH & Co KG is an ISO 9001:2015 certified bioanalytical service provider specialised in the application of biosensors based on surface plasmon resonance (SPR) for biomolecular interaction analysis (BIA). BIA technology is ideally suited for kinetic characterisation of any interacting molecules in real-time in a label-free state. Biaffin has extensive knowledge and many years of experience in various application areas and supports as a competent partner the drug development programs of pharma, biotech and generic drug companies, as well as scientific institutions worldwide. The service is performed by a highly specialised team (PhD level scientists) in a laboratory well equipped with several state-of-theart SPR instruments (Biacore). The company’s expertise is documented by a number of peer-reviewed publications in renowned scientific journals. Sufficient capacities in SPR instruments enable Biaffin to start interaction studies at short notice, to rapidly perform a number of projects in parallel and to obtain results on time.

Analytical services Biaffin’s SPR services in pre-clinical drug development comprise customised assay development, hit validation, secondary screening, kinetic profiling and lead optimisation of small-molecule drugs. Early ADME studies (serum protein binding) and detailed studies on the mode of action, including thermodynamic binding analysis, further support the drug development process.

In the field of therapeutic antibody and biosimilar development, Biaffin offers SPR services for qualitative kinetic ranking, comprehensive kinetic characterisation, determination of active concentrations based on binding activity (using calibration curves or calibration-free methods), batch to batch comparison, assay qualification/validation and stability analyses for diagnostic and therapeutic purposes. Pair-wise epitope mapping, tests for specificity, cross-reactivity, immune-reactivity, variances in binding kinetics based on species differences and interaction analysis with Fc gamma receptors (CD16, CD32, CD64) and neonatal Fc receptor (FcRn) complement Biaffin’s antibody services.

Biaffin

In addition, Biaffin offers customised SPR assay development and contract research elucidating specificity, selectivity, cofactor requirements, mechanism of action and thermodynamics of given interactions of proteins, peptides, nucleic acids, small molecules, carbohydrates and membranes. Biochemical and enzymatic assays based on microfluidic mobility shift technology (MMSA) and bioluminescence broaden the range of services to meet the complex issues of clients regarding inhibitor recognition by target enzyme, effects of small-molecule inhibitors on enzyme activity, substrate specificity and mode of action.

Catalogue products Apart from analytical services, Biaffin offers a broad range of products serving customers’ needs in kinase research and exploring cellular signal transduction pathways.

Biaffin’s high-quality products, available from the online shop www.Proteinkinase.biz, comprise recombinant proteins (kinases, phosphatases, cytokines, receptors, CD antigens), peptide substrates, specific inhibitors and antibodies, as well as biochemical assays (ATP determination kit, kinase assays) for customers’ in-house research.

Quality statement Biaffin has successfully implemented and maintains a Quality Management System certified according to ISO 9001:2015 international standard that enhances the ability to continually supply high-quality products and provide innovative services according to the highest quality standards, which consistently meet the needs and expectations of our clients.

7 th european biotechnology guide 2017

36 | 37

Name · BioArctic AB

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Warfvinges väg 35 SE-112 51 Stockholm Sweden Gunilla Osswald +46-8-695-6930 gunilla.osswald@bioarctic.se www.bioarctic.se

I 30 2003 R&D neuroscience

External · l Eisai Collaborations l AbbVie

With patients in mind BioArctic AB strives to improve the quality of life for patients with Alzheimer’s disease, Parkinson’s disease, and spinal cord injuries. This underpins everything we do. It reminds us why we exist as a company and helps us deliver on our objectives. It also sets the context for our employees’ activities and the roles of our teams, partners, and other collaborators.

We believe that science can alleviate the severe situation for patients suffering from Alzheimer’s disease and the chronic and progressive movement disorder of Parkinson’s. Today there are neither cures nor effective drugs to slow or halt the course of these devastating neurodegenerative diseases. There is also a huge and urgent medical need for an innovative treatment of complete traumatic spinal cord injury, a condition that currently lacks an effective remedy.

Our scientific approach BioArctic‘s proprietary technologies and dedicated personnel have made it possible to develop new immunotherapeutic approaches to neurodegenerative diseases.

We have developed a technology platform that proved successful when the company’s first drug candidate, the antibody (BAN2401) for Alzheimer’s disease, was developed. BioArctic’s technology is now applied to other CNS disorders such as Parkinson’s disease, and new antibodies are being developed.

The key molecular event in these diseases is protein misfolding and aggregation. The spread of soluble aggregates leads to neuronal dysfunction, cell death, brain damage and symptoms of disease. Each neurodegenerative disease is characterised by its unique aggregated protein. The hallmark of Alzheimer’s disease is amyloid-b (Ab), for Parkinson’s the signature protein is α-synuclein. An attractive treatment strategy is to eliminate these toxic proteins.

bioarctic

Business strategy and partnering

Brain images provided by PET-Centre, Uppsala University Hospital, Sweden, showing a normal brain (left) and an Alzheimer brain (right).

We realise that breakthrough science doesn’t happen in isolation. It happens through outstanding internal collaboration and successful external partnerships.

BioArctic was founded based on discoveries at Uppsala University and collaborates with researchers also at Karolinska Institutet, University of Gothenburg, Linköping University and Lund University, in Sweden.

Together with our partners we combine our best efforts, competencies, creativities, and resources to develop new innovative treatments for patients with large unmet medical needs.

The funding of development, clinical testing, and worldwide marketing is achieved by partnering with Big Pharma companies. BioArctic has so far partnered with Eisai, which is a leading company in the Alzheimer’s field, and in 2016 we entered into a partnership with AbbVie, concerning our Parkinson’s franchise. We strongly believe that current and future collaborations are the key to the continued success of BioArctic.

Rehabstation Stockholm, Sweden, showing robotic training used for rehabilitation.

7 th european biotechnology guide 2017

38 | 39

The information specialist

Name · BIOCOM AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Luetzowstr. 33–36 10785 Berlin Germany Dr Boris Mannhardt +49-30-264921-0 +49-30-264921-11 service@biocom.de www.biocom.de 32 1986 | Consulting | Publishing | Events

Biotechnology, life sciences, knowledge-based bioeconomy, medical technology: experienced industry and scientific specialists at BIOCOM have been tracking the development of life sciences from research to market for more than 30 years – content-driven and resultsoriented, enthusiastic about the subject and always committed to the customer.

To be close to its clients across Europe and optimally suppor t the media, event and ser vice activities, BIOCOM runs its headquarters in Berlin and has further offices in Brussels, Vienna and Zurich.

Consulting and studies As a leading information specialist in ­Europe, BIOCOM has extensive knowledge and experience in all life science areas, be it medtech, pharmaceutical development or the bioeconomy including agricultural innovation and industrial biotechnology. Building on this, the project management division offers a comprehensive range of services for companies and the public sector – wherever state-of-the-art biotechnology calls for specialised information and communication processes.

BIOCOM prepares market, financial and technologyspecific studies with the highest user value for its clients.

It conducts qualitative and quantitative analyses, developed closely with customers and delivering focused, accurate data. The result is clear, informative dossiers with highest quality information to effectively support professionals in industry and politics.

Industry surveys

Member of

European Biotechnology NET WORK

Consistent and internationally comparable statistics are a valuable tool for political decision makers to effectively support the life sciences. BIOCOM has longstanding experience in sector-specific surveys of both industry and academia. Based on global definitions such as the OECD’s biotechnology statistics framework, BIOCOM has so far performed surveys in several European countries. Survey results are kept in proprietary databases of the European life science sector and are aggregated and processed for publication.

BIOCOM AG

Publishing The unique feature of printed or electronic media published by BIOCOM is their relevance in practical work.

From magazines like European Biotechnology, up-to-date books, directories, internet platforms to videos, they are fact-based and strongly content-related – simply a must on many desks or screens.

Events Proprietary conferences, conventions and congresses have long been part of the company’s successful activities. BIOCOM events are a perfect example of content relevance and superb organisation. BIOCOM’s event management team also organises large and small events on behalf of customers: from focused workshops to large professional congresses and exhibitions with thousands of attendees and visitors.

Communication + dissemination In all research projects funded under the European Commission’s framework programme Horizon 2020, the work package of communication and dissemination is a key element. Progress of the project and relevant research results need to be published through various channels to make the project – and European funding activities as such – more visible. Under the COMDIS label, BIOCOM offers these services to research consortia across Europe.

To inform all stakeholders in a consortium as well as the interested public including policy makers about the objectives and results of the project, a coherent and clear communication strategy is essential. This is particularly true for large collaborative projects that involve many partners including universities and SMEs across Europe in a complex scientific approach over a long period of time. BIOCOM’s tasks in these projects comprise in particular: ·· Branding of the project and preparation of communication material ·· Creation and maintenance of the project website ·· Videos ·· Media work ·· Organisation of conferences and workshops 7 th european biotechnology guide 2017

40 | 41

Name · Bioengineering AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Founded (year) Areas of Activity

· · · · · · · · · ·

Sagenrainstrasse 7 8636 Wald Switzerland Stefan Lugert +41-55-25681-11 +41-55-25682-56 info@bioengineering.ch www.bioengineering.ch 1972 | Engineering & Design | Plants | Bioprocess control | Service | Lab & Pilot | Components

The visionary idea of providing the biotechnological industry and research community with equipment for excellence led to the foundation of Bioengineering AG in 1972. This idea has been put into practice by designing and constructing fermentation systems, including all components for large- and small-scale use. By expanding our product portfolio, based on new advancements in biotechnology, we are leading the company into the 21st century.

Bioengineering AG has been independent and autonomous since its establishment. Our approach has little in common with current corporate mindsets and the vast array of management models, which allegedly have answers for everything. Instead, we have the freedom to focus on a result-oriented commitment to process specifications. Our research and design teams know how to set customers’ ideas on the road to implementation and turn them into practical reality, based on optimised organisational structures and – not least – sound financial planning.

The best way to reach this goal is to involve us with a project – for instance the launch of a new product – as an initial partner right from the beginning. The internal operating structure of Bioengineering is based on the interaction of engineering disciplines (process consulting, planning, and design), measurement and control technology (process control sequences and plant automation), and production resources (processing and conversion of materials).

Product portfolio Our Lab & Pilot division manufactures standardised equipment for microbiological and cell cultivation from laboratory to pilot scale, ranging from 2L to 3,000L reactor volume. This division combines fixed product design concepts with the flexibility offered by a wide range of available options. The portfolio of Lab & Pilot is complemented by Components, which offers products for a complete Cleaning in Place (CIP) as well as solutions for media preparation and the Inversina Series of inversion tumbler mixers.

Bioengineering

The Bioprocess Control division specialises in all aspects of measurement and control required by modern biotechnology. It relies on our own System for Control and Data Acquisition, BioSCADA, which is based on GAMP5 Guidelines. BioSCADA is inspired by the need for on-line monitoring of the customer’s specific process. In addition to a variety of high-quality sensors it also features interfaces for the implementation of thirdparty equipment. Furthermore the expertise of Bioprocess Control lies in the automation of Bioengineering plants harmonised with the customer’s specifications.

Customers can take full advantage of the benefits of our modular design approach – reduced cost and rapid installation – thanks to prefabricated subsystems.

Our Design & Engineering division designs and builds facilities according to customer specifications and the requirements of the particular cultures in question. Our customers in research and biological industries such as pharmaceuticals, food processing, and chemicals appreciate this all-encompassing perspective. Providing customer consultation is an added service based on the background of our employees, which combines knowhow from biosciences and engineering disciplines. We accompany our customers through all stages: project management, project monitoring, general contracting, materials procurement and schedule monitoring, quality control, and acceptance testing.

Every customer enjoys the advantages of our modular design approach: cost-effective transport, rapid installation and streamlined testing, and quality control. Our quality-assurance manual is the control system that ensures unified monitoring and documentation of the entire production sequence, with precise specifications, instructions, and prescribed procedures. But the commitment to our customer does not end once the system is installed and qualified. For us, quality assurance also means providing our customers with aftersales service and replacement parts for many years to come. We have been honouring that commitment for every facility built

by Bioengineering since 1972.

7 th european biotechnology guide 2017

42 | 43

Name · BioMediTech – Institute of Biosciences and Medical Technology Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · ·

Biokatu 10 33520 Tampere Finland Juho Väisänen +358-40-1909834 info@biomeditech.fi www.biomeditech.fi >400 2011 Biosciences

Multidisciplinary research and education in life science BioMediTech, a joint institute of Tampere University of Technology (TUT) and University of Tampere (UTA), brings together a powerful mix of multidisciplinary expertise in life sciences and medical technology. At BioMediTech over 300 scientists conduct research and education in the fields of cell and molecular biology, genetics, biomaterials, biosensors, computational systems, biotechnology, biomedical engineering, and regenerative medicine. The institute aims not only to integrate and strengthen the local tradition of excellence in basic life-science research and teaching, but also to create new efficient platforms and processes for discovery and innovation.

Excellence in life science Our aim is to develop personalised medicine via new diagnostic and treatment methods. BioMediTech excels e.g. in biomaterials, stem cells, cancer, immunology, biosensors, imaging, and computational methods. The institute also houses FinMIT, the Academy of Finland Centre of Excellence in research on mitochondrial disease and ageing. During the first decade of 21st century the research groups of BioMediTech have produced close to 1,500 publications in international peerreviewed journals, produced nearly 100 patents and over 10 commercial spin-offs.

BioMediTech provides state-of-the-art laboratory and clean-room facilities, and implements relevant quality systems. These have enabled us, for example, to be among the first units in the world to initiate stem cell production in compliance with pharmaceutical manufacturing requirements (GMP standards) and, consequently, to produce stem-cell transplants for clinical use. Our adult stem-cell research group pioneered the generation of cranial bone derived from patients’ own fat tissue in 2007. Since then, over 20 patients have successfully received cranial and facial bone transplants created in this fashion.

Member of

European Biotechnology NET WORK

BioMediTech

BioMediTech developing human spare parts Tissue defects, invalidity and death caused by diseases and trauma cause not only annual costs worth billions of euros but also harm to people. For example, over 6,000,000 people suffer from osteoporotic bone defects in Europe annually and over 40,000 patients in Finland alone have dry type age related macular degeneration which currently can’t be treated with drugs or therapies.

Cell and tissue technologies are becoming the third most important form of therapy alongside medication and surgery. In the future these technologies may provide new solutions to diseases and trauma which currently don’t have effective treatments.

Human Spare Parts research programmme at BioMediTech is a world-class interdisciplinary research project in which people’s own cells can be used to build spare parts to replace damaged and degenerated body parts.

The aim of the project is to find better and more costeffective ways to build spare parts for people from their own cells. The programme combines 100 experts with top-level skills in biomaterials, sensor technology, biomedical engineering and stem cells to develop technologies and solutions leading to new therapies and drugs in the future.

The programme will produce solutions which in the future may be utilised, for example, in creating new bone tissue in cases of bone damage or nerve tissue in cases of spinal injury. Developed technologies will also enable to research among other things the cardiac side effects of medications and the development of new ophthalmological medications.

The Human Spare Parts programme has been granted over €20m research and infrastructure development funding from Tekes – the Finnish Funding Agency for Technology and Innovation, European Regional Development Fund through Council of Tampere region, City of Tampere, Tampere University of Technology and University of Tampere.

7 th european biotechnology guide 2017

44 | 45

Name · BIOTECON Diagnostics GmbH

Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Fax Email Website Social Media

· · · · ·

Hermannswerder 17 14473 Potsdam Germany Dr Kornelia Berghof-Jäger (CEO) Alois Schneiderbauer (CBO) +49-331-2300-200 +49-331-2300-299 bcd@bc-diagnostics.com www.bc-diagnostics.com

F I Q

Company profile BIOTECON Diagnostics, located in Potsdam, Germany, is one of the world’s leading companies for rapid microbiological testing methods for the food, feed, beverage, and pharmaceutical industries, as well as for other, related industries. Founded in 1998, the internationally operating biotechnology company develops, manufactures, and markets its foodproof® and microproof® product lines.

The high-quality products offer innovative rapid solutions for DNA/RNA extraction and detection of a wide range of test parameters based on real-time PCR.

foodproof ® products BIOTECON Diagnostics’ foodproof® product line ensures fast and accurate detection of pathogens, viruses, spoilage organisms such as beer spoilers or Alicyclobacillus, GMOs, and allergens, as well as animal species testing in all kinds of food, feed, and beverage matrices. The kits are used by producers of food and beverages, including some of the biggest food companies in the world, as well as by government laboratories, research facilities, and private custom service laboratories.

Many foodproof® kits for the detection of pathogens are validated and approved by independent institutions such as AOAC, NordVal, and MicroVal. These include the kits for Salmonella, Listeria monocytogenes, Cronobacter spp., E. coli O157, Enterobacteriaceae, and others.

foodproof ® automation solutions for the food industry The foodproof ® RoboPrep+ Series is a set of commercially available, fully automated DNA-extraction and PCR setup systems validated and certified for the food and beverage industry. The RoboPrep+ Series provides fully automated solutions for DNA extraction and PCR setup for all food testing applications and throughput demands, effectively reducing hands-on time and error sources, while significantly increasing laboratory efficiency. The systems have been optimized especially for the food industry and are applicable for the detection of all foodrelated organisms in various food matrices and environmental samples. Several foodproof® Magnetic Preparation Kits enable the automated extraction of DNA from

Biotecon diagnostics

food and feed samples for the detection of pathogens, GMOs, animal species, and allergens. The foodproof ® RoboPrep+ Series comprises different types of robots suitable for food testing applications, e.g. the KingFisher® Flex instrument, which isolates DNA from bacteria, GMO, or allergens within 45 minutes for up to 96 samples.

microproof ® products The microproof® product line offers highly specific and fast solutions for the pharmaceutical and cosmetic industries. For example, Staphylococcus, Micrococcus, and Corynebacterium are easily and simultaneously detected and identified in environmental monitoring samples with the microproof® Hygiene Screening System.

Certified quality BIOTECON Diagnostics is dedicated to providing the highest quality products and services. The company markets its products directly as well as through a continually growing network of local distributors and worldwide sales channel partners. Through certification and accreditation, the company builds trust and demonstrates transparency to customers. BIOTECON Diagnostics has been DIN EN ISO 9001 certified since 2003 and has maintained DIN EN ISO 17025 accreditation in the service sector since 2005.

Service testing & development The company’s ISO 17025 accredited custom service laboratory provides superior experience in microbiological and molecular biological service testing of food and beverages, water and disinfectants, as well as pharmaceutical and cosmetics products.

BIOTECON Diagnostics offers a customised contract development. Due to close contacts with many different industries, the company is well aware of customers’ current and future challenges in the fields of real-time PCR, MALDI-TOF-MS, microarrays, and sequencing.

BIOTECON Diagnostics is thus able to provide flexible solutions to production and processing companies through new, tailored, and economical approaches. For MALDI-TOF-MS the company provides own databases for specific food categories (e.g. dairy) and works in a close cooperation with a leading provider of this technology.

7 th european biotechnology guide 2017

46 | 47

BioVersys AG

Name · BioVersys AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Hochbergerstr. 60c 4057 Basel Switzerland Marc Gitzinger +41-61-633-22-50 +41-61-633-22-59 info@bioversys.com www.bioversys.com

L 10 2008 Classes 1 and 2 R&D of antibiotics

Biological Patents · Yes External · | GSK Collaborations | Wellcome Trust | Satt Nord (Université Lille, Institut Pasteur, INSERM) | Swiss TPH | NIAID | Beam Alliance | ZHAW | FHNW | University of Basel | APTUIT | PSI Request for · Collaboration and licensing partners Further Collaborations

Member of

European Biotechnology NET WORK

Bioversys AG is a privately held Swiss biopharmaceutical company located in the Technology Park Basel that focuses on the research and development of new drugs which switch off drug resistance within bacterial pathogens and restore the efficacy of approved antibiotics.

Spun out of the ETH-Zurich in 2010, the company has profound technological expertise that is based on solid IP. BioVersys has its own laboratory facilities and currently employs ten highly qualified people led by CEO Dr Marc Gitzinger, CSO Dr Sergio Lociuro and Dr Peter Sennhenn (VP Medicinal Chemistry). BioVersys has an ongoing collaboration with GSK and the Wellcome Trust for their lead project.

Combating antimicrobial resistance Aiming at the intracellular pathways responsible for bacterial resistance, BioVersys’ approach is based on the identification and inactivation of bacterial resistance factors in relevant pathogens. One of its lead series has already exhibited excellent characteristics in rendering multidrug resistant Mycobacterium tuberculosis sensitive again to an approved antibiotic. BioVersys’ lead project is currently in preclinical studies and has achieved proof-of-concept in animal models. Currently, the company is expanding its screening and compound portfolio to nosocomial bacterial strains (e.g. Enterobacteriaceae or Acinetobacter baumannii) that contribute not only to the escalating costs of patient care but also cause high numbers of casualties worldwide.

Antibiotic resistance – an urgent medical need There is an urgent medical need for new treatments against life-threatening bacterial infections. Many lifesaving antibiotics have lost their effectiveness due to the evolution of multidrug resistant bacteria. For example, in the USA, each year at least two million people become infected with bacteria that are resistant to antibiotics and about 23,000 people die each year as a direct result of these infections. Unfortunately, a lot of the major pharmaceutical companies have left the field of antibacterials and the pipeline for new treatments has dried up.

Bioversys

The high prevalence of resistant bacteria is considered a major public concern and there are governmental initiatives worldwide, such as the 6th Innovative Medicines Initiative in Europe and the Generating Antibiotic Incentives Now (GAIN) act in the USA, that recognise the need for new therapies. Recently, the 300 year-old prestigious Longitude Prize chose antibiotic resistance as the next humanitarian challenge for the 21st century.

The market Development of anti-infectives enjoys the highest success rate in drug development because animal data are more predictive of human efficacy and safety than in any other indication. The global antibacterial market is one of the biggest and accounted for sales of $39.6bn in 2013. The nosocomial (hospital acquired infections) segment is expected to dominate the market in the near term.

Examples of marketed drugs showing activity against multiple drug-resistant bacteria strains show the potential for BioVersys’ compounds: Daptomycin (introduced 2003) had sales of US$967m in 2013, Linezolid (introduced 2000) US$1.35bn, Tigecycline (introduced 2005) US$358m. BioVersys estimates that its compounds will serve a similar unmet medical need and, hence, have the potential to generate comparable peak sales.

Collaborations and network BioVersys continues their collaboration with GSK and the Wellcome Trust for their tuberculosis project. The collaboration is built on BioVersys’ proprietary TRIC technology (Transcriptional Regulator Inhibitory Compounds) and is developing a preclinical candidate for this highly underserved indication. In 2015 BioVersys AG joined the Beam Alliance. The BEAM Alliance will work to improve the regulatory, investment, and commercial environments in Europe for research, development, approval and market viability of new products combating antimicrobial resistance. Dr Gitzinger is serving as VP on the board of directors. The company also collaborates with a range of academic institutions in Switzerland (e.g. ZHAW, Swiss TPH, FHNW, University of Basel) and internationally (e.g. SATT Nord, France (comprising Université Lille, Institut Pasteur and INSERM) and the US NIAID). BioVersys is actively seeking new partners for collaboration and licensing.

7 th european biotechnology guide 2017

48 | 49

Name · BioWin asbl

Address/P.O. Box · Maison de l’Industrie – Rue Auguste Piccard 20 Postal Code/City · 6041 Gosselies Country · Belgium Contact Person · Amélie Moyaerts Email · amelie.moyaerts@biowin.org Website · www.biowin.org Number of Employees · 11 Founded (year) · 2006 Areas of Activity · | Health biotechnology & medical technologies | Biopharmacy & Vaccines | Cell Therapy & Regenerative Medicine | Biomanufacturing | Diagnostics (in vitro & in vivo) | Radiation applications in healthcare | Implanted medical devices | Non-implanted medical devices & instruments | Digital technologies External · Partnerships with: Collaborations | Massachusetts Life Sciences Center (USA) | Juke Biotech Park (China) |C ouncil of European BioRegions (CEBR) | European Diagnostic Clusters Alliance (EDCA) | Guangzhou Bio (China) | CQDM (Canada) | Alsace BioValley (France) | Eurobiomed (France) | Lyonbiopôle (France) | Atlanpole Biotherapies (France) | Medicen (France) Request for · | European program H2020 Further Collaborations | Regional and international calls for R&D and Skills Development projects

Cluster presentation BioWin is the Health competitiveness cluster of Wallonia (Belgium), and its mission is to support the growth and competitiveness of the sector by bringing together stakeholders participating in R&D innovative projects and/or skills development in the fields of health biotechnology and medical technologies.

The technological domains encouraged by the cluster cover all healthcare-related fields. The cluster gathers about 160 members (5 universities, 7 global leaders and 148 innovative SME’s).

Our services ·· Research & Development: supporting excellence while ensuring that the technologies/products developed meet market’s needs and can be launched as quickly as possible. Helping members to apply for regional calls (twice a year) as well as international calls including the European H2020 programme. Up to now, the BioWin portfolio counts 43 granted R&D projects for a total budget of €138 million involving 246 organisations (companies, research centers and universities). These projects are strongly supported by the Walloon Governement (up to 75% of public funding). ·· Skills Development: supplying integrated and centralised training offers to develop the technical, managerial and strategic skills of biotech companies to support the growth and competitiveness of the sector; offering a one-stop shopping platform including the complete portfolio of continuous trainings in Wallonia for the health sector. Encouraging regional calls for projects twice a year. In 2016, our portfolio counts 16 granted training projects. They generally focus on emerging jobs or jobs suffering from occupations and they target job seekers, academics and industrials.

biowin

unity mm o C

Visi bil ity

Team

ork Netw

in

ov es atio ea n rc h

in Tra g

In

E v e nt s

n r &

·· Internationalisation: organising networking activities, partnerships and technological matchmakings. Offering access to networks co-founded by the cluster: Wal-Dx (Wallonia in vitro Diagnostics), Rad4Med.be (Belgian network for Radiation Applications to Healthcare) and EDCA (European Diagnostic Clusters Alliance). As a result, we have bilateral agreements with 3 international clusters: CQDM (Canada), Alsace BioValley (France) and Massachusetts Life Sciences Center (USA). ·· Technological Platforms: promoting the creation of technological platforms and infrastructures. For example, MaSTherCell, first technological platform dedicated to the manufacturing of cell therapy products in Wallonia; the proton therapy platform dedicated to treatment and research; the BWB biobank platform incorporating the biobanks of university hospitals from the Wallonia Brussels Federation.

Become a member !

Your gateway to health biotech and medtech excellence in Wallonia

BioWin welcomes international members. You want to benefit from BioWin’s services? Contact us now! contact@biowin.org

7 th european biotechnology guide 2017

50 | 51

Name · Boehringer Ingelheim Biopharmaceuticals GmbH Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone · Fax · Email · Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · ·

Binger Strasse 173 55216 Ingelheim am Rhein Germany Matthias Kagerbauer Corporate Communications +49-6132-77-0 +49-6132-72-0 bioxcellence@boehringeringelheim.com www.bioxcellence.com  >47,500 in 2015 1885 in Ingelheim, Germany S1 Focus on human pharmaceutical and animal health businesses.

Net Sales · €14,798 million in 2015 Relevant R&D Budget · €3,004 million in 2015 Request for · Boehringer Ingelheim BioXcellence™ Further Collaborations seeks companies in need of biopharma development and GMP manufacturing services and helps customers to get their products to market on time.

Company profile The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 146 affiliates and more than 47,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros.

Boehringer Ingelheim Contract Manufacturing is represented by its brand Boehringer Ingelheim BioXcellenceTM your dedicated biopharma contract manufacturer. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience it has brought more than 25 biopharma products to market. Boehringer Ingelheim BioXcellenceTM offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA) and Shanghai (China).

Boehringer Ingelheim BioXcellenceTM can secure product supply throughout the entire product lifecycletransferring customer projects at any stage, delivering to almost any scale.

Boehringer Ingelheim BioXcellenceTM makes outsourcing easy.

Boehringer Ingelheim’s BioXcellenceTM services At our cell culture sites in Biberach (Germany), Fremont (USA) and Shanghai (China) we have a total capacity of up to 300,000 l with flexible scales for clinical and commercial supply of between 400 l and 15,000 l. At our microbial site in Vienna (Austria) we have more than 15,000 l with flexible scales for clinical and commercial supply from 200 l to 6,000 l.

Boehringer Ingelheim

We offer the following: ·· Genetic engineering ·· Cell line and strain development ·· Up- and downstream processing ·· Fast and tailored project transfers ·· Large-scale GMP facilities licensed by the EMA, the FDA and the MHLW ·· Formulation and pharmaceutical process development ·· Fill and finish (including innovative application devices) ·· Quality control and assurance

Boehringer Ingelheim’s BioXcellenceTM experience Boehringer Ingelheim BioXcellenceTM offers reliable world-class biopharmaceuticals contract manufacturing to the pharmaceutical and biotechnology industry.

We offer a complete range of services, from cell line and strain development through process development and large-scale manufacturing to fill and finish. Our extensive portfolio of capabilities and technologies includes the production of antibodies, recombinant proteins, nonantibody scaffolds, Fab fragments, as well as pDNA from both mammalian cell culture and microbial fermentation systems.

Opportunities for our partners ·· F rom DNA to drug product in one seamless, integrated process. ·· S mall- as well as large-scale cGMP production in multi-product facilities that are approved by the major authorities. ·· The confidence that you are working with a contract manufacturer that has helped bring 27 biopharmaceuticals to the market and an outstanding track record of >150 projects successfully optimised and transferred. ·· Transparent processes and first-class project management allowing you to step in at any stage of development.

7 th european biotechnology guide 2017

52 | 53

Name · Cambridge Cell Networks Ltd

Address/P.O. Box · St John’s Innovation Centre Cowley Road Postal Code/City · CB4 0WS, Cambridge Country · United Kingdom Contact Person · Gordana Apic Telephone · +44-1223-703-137 Fax · +44-1223-858-794 Email · gordana.apic@camcellnet.com Website · www.camcellnet.com Social Media · I Number of Employees · 10 Founded (year) · 2003 Areas of Activity · | Bioinformatics | Computing | Scientific databases | Systems biology research | Drug discovery, safety and toxicology | Consulting annotation services

Cambridge Cell Networks (CCNet) is a Cambridge UKbased technology company that has been providing solutions, databases and software for researchers and decision makers in the pharmaceutical, chemical, nutrition and agrochemical industries over the last ten years.

CCNet has a track record of maintaining the technical as well as scientific cutting edge and delivering reliable products and services to our customers. Our core management team has over 100 man years of experience in Pharmaceutical and Industrial R&D and our scientists have produced nearly 200 man years of high quality expert curated content for our databases helping our clients to make fast hypothesis about how chemicals act on biological systems.

With a strong expertise in computing, bioinformatics, Systems Biology and Toxicology, CCNet develops tools for scientists who need to better understand on- and -off target mechanisms of action of compounds and the links between genes, targets, chemicals and pathologies.

Annual Turnover · €500.000 External · FP7 Health programme: Collaborations projects – Notox, SYSCILIA, Nucleosome4D

Cambridge Cell Networks is a molecular knowledge enterprise, offering benefits from our solutions combining expert databases and analytical software to: ·· get a fast insight into chemical effect on biological systems ·· access hundreds of man years of expert curated information on chemicals, proteins and genes and their interactions ·· elucidate biological mechanisms underlying your observations ·· speeding up chemical safety assessment ·· prioritising candidate compounds early in their development ·· reduce animal testing and translate effects from model organisms to humans

Products and services

Member of

European Biotechnology NET WORK

Our exper t databases include products such as ToxWiz, where one can access millions of manually extracted observations related to mechanism of toxicity and find mechanistic details thousands of times faster than by traditional literature searching. We also

Cambridge Cell Network

offer an online version, ToxWiz Online, which allows rapid access to millions of manually extracted observations related to mechanism of toxicity and mechanistic insights anywhere you access the web.

Additionally, Sabida is a web-based solution for rapid identification of gene or protein biomarkers of chemically induced pathologies. The tool allows one to study particular pathologies for biomarker candidates and to analyse one’s own gene or protein expression datasets for overlaps with more than a thousand manually curated pathology signatures.

Consulting & annotation services Our scientific and technical consultants offer expertise and advice in analysing and assessing your research needs and providing solutions in the appropriate area.

We have a large team of scientists that can be assigned to a range of projects. This ranges from data mining, curation, extraction & analysis to software design and implementation.

Our specialities include: ·· mining & curation of molecular interactions & associations ·· mining & curation of toxicology relevant data ·· predicting mechanisms of toxicity using chemical, toxicogenomic or proteomic data ·· software development We aim to help you maximise the return on your investment, and ultimately improve your processes.

Technical solutions – either databases or software – can be deployed safely across your organisation, thus making your research and development process more effective.

7 th european biotechnology guide 2017

54 | 55

Name · Technological Cluster Campania Bioscience SCaRL Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email

· · · · · · ·

Via L. De Crecchio, 7 80138 Naples Italy Roberta Lauro, Luigi Pavia +39-0815667677 +39-0815667677 r.lauro@campaniabioscience.it l.pavia@campaniabioscience.it Website · www.campaniabioscience.it Founded (year) · 2013 Areas of Activity · l Biotech l Health l Agri-food External · l ALISEI – Italy’s Life Science Cluster Collaborations l European Biotechnology Network l Council of European Bioregions

Request for · Campania Bioscience is strongly Further Collaborations interested in: l exploring opportunities for cooperation with other EU clusters/ companies/research centres for technology/research/business cooperation l finding partners for joining EU projects (H2020; COSME and other opportunities) l exchanging of good practices with similar entities

Campania Bioscience operates as a Campania region institutional cluster, gathering together competences and facilities in the fields of Health, Biotech, and Agrifood with a commitment to valorising the regional life sciences ecosystem.

Our mission is to generate a positive impact within our national community by sharing innovative products and services and strengthening regional investment attractiveness and competitiveness, also by contributing to the training of highly qualified professionals in the field of life sciences.

The cluster is composed of seven research entities (universities and national research centres comprising about 1,000 researchers), 46 companies (both small/medium and large) and two technology transfer agencies.

Campania Bioscience’s key competences: ·· Pharmacogenomics ·· Bioinformatics ·· Industrial Biotechnologies ·· Gene expression and proteomics ·· Nutraceuticals, cosmeceuticals, and functional foods ·· Bioremediation and biodegradation ·· Molecular diagnostics ·· Gene therapy The cluster is responsible for the management and implementation of several projects funded by the Italian Ministry of Education, University and Research, with an overall value of €40 million.

We firmly believe that our initiatives play a crucial role in terms of social impact, and for this reason we foster a seamless debate with local and national institutions and stakeholders on how to tackle contemporary challenges with our science, innovation, and passion.

Member of

European Biotechnology NET WORK

Campania Bioscience

Technological trajectories and projects Design and production of cosmeceuticals and nutraceuticals ·· Novel formulations of functional/enriched food (oil, tomatoes) for the prevention and therapy of metabolic and cardiovascular pathologies ·· Delivery systems for the release of micro-molecules encapsulated with nutraceuticals/cosmeceuticals Diagnostics, biosensors, and innovative technologies for the biomedical industry ·· Genetic-molecular traceability and food monitoring ·· Innovative biomedical devices for the treatment of infected surgical wounds ·· Development and testing of medical devices for the treatment of skin lesions and processes of tissue regeneration Design and testing of new therapies ·· New therapies for the treatment of high-impact diseases (cardiovascular, oncology, neurological …) ·· Productive bioprocesses for molecules of pharmaceutical interest

Supporting new emerging industries in personalised health Together with 7 other European clusters, Campania Bioscience has won a prestigious EU Horizon 2020 project with a budget of €5 millions.

The INNOLABS project aims to foster collaboration, transfer of knowledge, and opportunities among SMEs belonging to the fields of ICT, Health, BIO, and Medicine from different countries in order to develop, improve, and deliver disruptive technologies mainly related to mHealth, personalised healthcare, and ageing populations. INNOLABS will select more than 100 innovative project ideas to accelerate and further support monetarily and with innovation services.

Starting on the 1st of January 2017, the project will last for 2.5 years and is supported by Horizon 2020, the EU Framework Programme for Research and Innovation.

7 th european biotechnology guide 2017

56 | 57

Name · Centre for Integrative Biology University of Trento Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Via Sommarive 9 38123 Italy Prof. Alessandro Quattrone +39-0461-282742 +39-0461-283937 cibio.research@unitn.it www.unitn.it/en/cibio 180 2008 University Research Centre | Cancer Biology & Genomics | Cell & Molecular Biology | Microbiology & Synthetic Biology | Neurobiology & Development

Request for · Research and SMEs partners for EU Further Collaborations projects and knowledge/technology transfer

The Centre for Integrative Biology (CIBIO) is a new interdisciplinary Centre at the University of Trento, one of the top-ranked academic institutions in Italy. CIBIO is the first initiative in molecular medicine and biotechnology in Trentino, an autonomous province of Italy characterised by a high level of public investment in innovation and research. CIBIO has recently grown to 33 laboratories headed by successful and international researchers and is rapidly expanding to become a University department.

The mission of the centre is to promote an integrative view of fundamental biological processes and of their derangement in disease, whereby basic science co-exists with biomedical oriented translational approaches.

Research at CIBIO covers research topics all emphasising experimental analysis at the various levels of biological organisation and focusing on four major research programmes: Cancer Biology & Genomics, Cell & Molecular Biology, Microbiology & Synthetic Biology, and Neurobiology & Development.

The research programmes established at CIBIO are interconnected by a high degree of internal cooperation, in the setting of a vibrant experimental environment characterised by the coordinated work of young independent group leaders and advanced postdoctoral fellows.

As a new centre, CIBIO has acquired state-of-the-art equipment covering all the tools necessary for biomedical projects to be carried out with the required level of technological sophistication with commonly shared instrumentation facilities operated by dedicated staff scientists, including:

Member of

European Biotechnology NET WORK

High-Throughput/High Content Screening Facility: Combining high technology instrumentation and large collections of screening compounds it allows to perform RNAi-based gene knock-down for genomic screens, in addition to chemical screenings with over 15000 drugs or drug-like small molecules. High Content Analysis and Screening are provided for phenotypic assays.

Cibio

Next Generation Sequencing Facility provides cutting edge next generation DNA/RNA sequencing technology operating on Illumina HiSeq 2000, Illumina MiSeq and Ion Torrent PGM, and is expanding with other applications on this platform.

Microarray Facility covering the processing of cell lines (for the extraction of total and polysomal RNA) as well as tissue samples for genome-wide hybridisation studies.

Cell Analysis and Separation Facility: An up-to-date laboratory for both flow cytometric analysis and cell sorting.

Key capabilities are rare-cell sorting, cell-sorting of small cell loads and single cell sorting and analysis.

Cell Technology Facility focusing on high-qualified techniques in the field of induced Pluripotent Stem Cells (iPSC) and genome editing.

Advanced Imaging Facility provides access to advanced biomedical imaging technology including state-of-theart microscopes, as well as image analysis software packages.

Bioinformatics Facility provides services for data storage and software requirements, and qualified assistance for data analysis.

Bioanalytical Mass Spectrometry Facility including nano/ analytical-flow-liquid chromatography systems coupled with high-resolution-MS and various platforms for purification and separation of proteins and peptides.

Protein Science Facility for protein expression, structural and functional characterisation, and protein complexes studies Advanced Molecular Diagnostics (AMD): an independent decision-making structure and service, offering molecular diagnostic services on biological samples from hospitals or clinical structures. It also performs research to develop new diagnostic techniques and to implement and optimise existing techniques.

7 th european biotechnology guide 2017

58 | 59

Name · Cinfa Biotech

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · ·

Travesía de Roncesvalles, 1 31699 Olloki (Navarra) Spain Dr Ruediger Jankowsky +34-948-33-50-05 info@cinfabiotech.com www.cinfabiotech.com 20 2013 | Development | Manufacturing | Commercialisation Areas of Activity · Biosimilars

The company Cinfa Biotech is the biosimilar company of the Spanish Infarco group, with headquarters in Pamplona, Spain and offices in Munich, Germany. The Company is committed to developing, manufacturing and commercialising high-quality biosimilars for oncology and inflammatory diseases, addressing the growing need for affordable therapies based on proven science, quality, safety, and efficacy. Cinfa Biotech’s biosimilars will widen the spectrum of therapeutic options, taking into account the special requirements of patients, physicians, pharmacists, healthcare service providers, and business partners.

Cinfa Biotech is backed by a powerful parent company, Infarco, which provides 50 years of experience in the development, manufacturing, and commercialisation of pharmaceuticals. Infarco’s first subsidiary, Laboratorios Cinfa, has become a successful developer and manufacturer as well as a recognised leader in the Spanish pharmaceutical market. Laboratorios Cinfa offers a broad portfolio of quality drugs and is the laboratory with the strongest presence in Spanish homes. The founding of Cinfa Biotech and the initial investment underline Infarco’s determination to now apply its successful business model to biosimilars.

Cinfa Biotech shares the innate values of the Infarco family, aiming at the pharmacists’ credibility and professional excellence, inspired by innovation. A deep understanding of protein-based therapeutics and disease biology has enabled the team at Cinfa Biotech to define efficient biosimilar development programmes, based on actual scientific and regulatory considerations. The team of renowned experts with decades of in-depth biosimilars experience in different indications, supported by a worldwide partner network, ensures that Cinfa Biotech’s development gains further momentum.

cinfa biotech

Products Cinfa Biotech is creating a pipeline of high-quality biosimilars for several indications in oncology and inflammatory diseases. Product development, clinical studies, manufacturing, and quality control are conducted in Europe according to the highest European standards.

The company’s lead product candidate is B12019, a biosimilar version of Neulasta ® (pegfilgrastim) to treat chemotherapy-induced neutropenia. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) receptor agonist, is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infection in patients undergoing chemotherapy. B12019 entered clinical development in the fourth quarter of 2015. The clinical development programme is based on scientific advice from the European Medicines Agency (EMA). In December 2016 at the annual conference of the American Society of Hematology (ASH) and in January 2017 at the European Cancer Congress (ECCO), Cinfa Biotech presented data showing the comparability of pharmacokinetics, pharmacodynamics, and bioavailability of B12019 in comparison with Neulasta®, its reference product.

Results of a 2nd clinical trial are expected in 2017.

A GMP production process has been established for B12019 at commercial scale.

Partners Cinfa Biotech is seeking professional partners with a strong footprint in their local market and disease expertise in oncology and inflammatory diseases. The company has the structure, flexibility, and entrepreneurial knowhow to develop solutions tailored to the needs of partners and customised for local markets. Cinfa Biotech’s cooperations are guided by the experience that simple business solutions often harbour the highest potential for future development.

6 th european biotechnology guide 2016

60 | 61

Name · Clariant

Address/P.O. Box · Postal Code/City · Country · Contact Person · Telephone · Fax · Email Address · Internet Website · Social Media Number of Employees · Founded (year) · Areas of Activity ·

Semmelweisstraße 1 82152 Planegg Germany Dr Martin Vollmer +49-89-710-661-0 +49-89-710-661-122 biotech@clariant.com www.clariant.com

FL I G   17,442 (group) 1995 (group) Clariant’s four business areas: l Care Chemicals l Catalysis l Natural Resources l Plastics & Coatings Group BIO’s areas of activities: l Biorefinery l Biocatalysis l Cellulosic ethanol l Biobased chemicals l Enzyme and strain development

Annual Turnover · CHF 5,847 bn (group) External · Among others, Bio-based Industries Collaborations Public-Private Partnership

Company profile Clariant is a globally leading specialty chemicals company, based in Muttenz near Basel/Switzerland. In 2016 the company employed a total workforce of 17,442. In the financial year 2016, Clariant recorded sales of CHF 5,847 billion for its continuing businesses which consist of the following four business areas: Care Chemicals, Catalysis, Natural Resources, and Plastics & Coatings.

Clariant’s corporate strategy is based on five strategic pillars: focus on innovation through R&D, add value with sustainability, reposition of the portfolio, intensify growth, and increase profitability.

In 2015, Clariant opened its new Clariant Biotech Centre (CBC) – a dedicated biotechnology and renewable research and development site – in Planegg near Munich.

Clariant’s Group Biotechnology focuses on developing tailor-made biotechnological processes for the economic and sustainable production of bio-based chemicals and biofuels and offers its customers one-stop system solutions ranging from renewable feedstock, biocatalytic, catalytic, and chemical conversion to downstream processing.

For example, Clariant has developed the sunliquid ® process, which uses enzymatic hydrolysis followed by fermentation to efficiently and sustainably produce cellulosic ethanol from agricultural residues such as wheat straw, corn stover, and sugarcane bagasse.

Since 2012, Clariant is operating Germany’s largest plant for cellulosic ethanol production, in Straubing. The plant represents the complete production chain, including pretreatment, process-integrated production of feedstock and process-specific enzymes, hydrolysis, simultaneous C5 and C6 fermentation, and energy-saving ethanol separation. The process itself is energy neutral, yielding cellulosic ethanol with an approximately 95% reduction of CO2 emissions. Moreover, the process is flexible for use with different feedstock and different production plant concepts. Additionally, the technology opens up a pathway to a second-generation sugar platform to ultimately produce green chemicals for a wide range of applications.

Clariant

Together with Mercedes-Benz, one of the world’s largest car manufacturers, and Haltermann, a leading producer of high-performance hydrocarbons, Clariant launched a twelve-month field test applying sunliquid® cellulosic ethanol in high-quality E20 fuel (sunliquid®20). The fleet test proved the high quality and excellent properties of the sunliquid®20 fuel: 20% cellulosic ethanol in series cars leads to a significant increase in the sustainability of the fuels, as it reduces 50% of particle emissions compared to the EU reference fuel EU5. In comparison to fossil fuels, sunliquid® cellulosic ethanol saves around 95% in greenhouse gas emissions, without being in competition with food- and feed production. The fleet test also demonstrated that the fuel is market-ready and technically compatible in series vehicles.

In another project with Scania, one of the top heavyduty vehicle manufacturers, Clariant started using second-generation ethanol as part of the fuel in operating the Ecotrucks in 2016. This ethanol is manufactured from sugar cane bagasse using the innovative sunliquid® technology.

Both tests show that second-generation biofuels based on agricultural residues are now technologically ready and available, not only in production but in application as well.

In 2016, Clariant, in cooperation with Werner & Mertz, the producer of Frosch® products, launched a project which expands the possible applications of bioethanol made from agricultural residues to detergents, cleansers, and cleaning agents.

7 th european biotechnology guide 2017

62 | 63

Name · CRS Clinical Research Services Andernach GmbH Address/P.O. Box Postal Code/City Country Subsidiaries

· · · ·

Lohmannstrasse 2 56626 Andernach Germany l Andernach l Kiel l Lübeck l Berlin l Wuppertal l Mönchengladbach l Mannheim

Contact Person · Dr Volker Menschik SVP Business & Corporate Development Telephone · +49-30-859-949-401 Fax · +49-151-52-64-16-33 Email Address · info@crs-group.de Internet Website · www.crs-group.de Number of Employees · 285 Founded (year) · Merger 2006, Foundation of Legacy up to 1977 Type of Company · Full-Service CRO Areas of Activity · l Consultancy l Project Management l Clinical Conduct l Quality Assurance l Clinical Trial Supply Management l Clinical Data Management l Statistics l Medical Writing l Laboratory/Bioanalytical Services by external partners

Your european expert in clinical trials CRS is one of the leading European full-service CRO in early clinical development (FIH, FIP, FIC) and has almost 40 years of experience in the performance of clinical trials.

Six German Clinical Pharmacology Units (CPUs) of CRS are located in metropolitan areas to ensure fast recruitment and the availability of a large pool of volunteers and patients. Thus, the timely and cost-efficient conducts of clinical trials, including standard human pharmacology trial designs in numerous therapeutic fields of expertise as well as in special (patient) populations, is guaranteed. Through the strictly standardised Phase-I environment and the internal QA/QC procedures existing in the CPUs, CRS is able to handle multi-centre settings within its company.

The excellent quality of CRS’s services is demonstrated by a track record of more than 2000 successfully completed trials. CRS is regularly audited by sponsors and inspected by authorities (FDA, EMA, BfArM, AFSSAPS, ANVISA, etc.).

An outstanding part of CRS’s business is the conduct of Early Phase patient trials. The close connection of the CPUs to university hospitals provides access to patients of various therapeutic areas and to further hospital infrastructure. The CPU Lübeck is directly situated on the campus of the University Hospital Schleswig-Holstein (UKSH), the one in Kiel close by. The CPU Mannheim is located in a region housing famous research institutes such as the German Cancer Research Centre (DKFZ) as well as the renowned University Hospitals of Heidelberg and Mannheim.

In-house Capacity · 275 beds Request for · Our team of business development is Further Collaborations happy to discuss your project and to propose tailor-made solutions for the clinical development of your product.

Please do not hesitate to contact us: info@crs-group.de

Whereas the CPU in Kiel has excellent experience in the conduct of clinical trials in renal & hepatic impaired patients, the other CPUs of CRS focus on further therapeutic areas and populations.

CRS

Special fields of expertise

Lübeck

Berlin

·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Renal & hepatic impairment Respiratory/inhalation devices Medical devices High-precision QTc trials (updated ICH E14 Guideline) Interaction trials (food, drug, & genotype) Women’s health/gynaecological examinations Dermal & transdermal applications/skin safety Controlled drugs (e.g. opioids) Nutritionals Vaccines Diabetics

Infrastructure – Locations – Expertise Wuppertal

Andernach, headquarters of CRS, coordinates the activities and provides access to one of the leading transdermal drug delivery providers.

Kiel, a 26-beds CPU located in close proximity to the University Hospital, is focused on patient trials in renal and hepatic impairment.

Lübeck, a 12-bed CPU enables clinical trials in a University Hospital setting and has direct access to patients and hospital infrastructure.

Berlin, a CPU with 36 beds, has outstanding expertise in clinical trials concerning women’s health, including gynaecological examinations on-site.

Wuppertal, a CPU with 45 beds, has a focus on metabolic & cardiovascular diseases and is experienced in complex ECG trial designs.

Mönchengladbach, a CPU with 54 beds, is specialised in trials regarding men’s & women’s health, skin safety, cardiovascular diseases, and nutritionals.

Mannheim, the largest CPU with 102 beds, provides special expertise in respiratory research and in challenging trial designs, e.g. first-in-man & thorough QT. Medical writing, data management, statistics & QA/QC as modular services are also offered.

7 th european biotechnology guide 2017

64 | 65

Name · Drooms GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Eschersheimer Landstraße 6 60322 Frankfurt Germany Luisa Jacinto Fragata +49-69-478 640-246 +49-69-478 640-1 l.fragata@drooms.com www.drooms.com

L I Q 110 2001 | M&A | Life Sciences/Biotech | Legal | Real Estate

Drooms is the leading provider of data rooms in Europe, facilitating highly secure access to confidential documents as well as the ability to exchange them with third parties around the globe. Drooms allows for the transparent and secure management of confidential business processes in the pharmaceutical and biotechnology industry, such as mergers and acquisitions, the protection of intellectual property, and company communications.

Intellectual property at the core of business processes Originally, the protection of intellectual property was ensured by limiting access to confidential information to a smaller circle of people within a company. Today, as work processes such as data sharing dematerialise, keeping control over confidential information has become increasingly challenging. This is even truer for companies that pay little attention to the technologies they use for sharing documentation with third parties.

Risk scenarios in the life sciences There are at least five scenarios in the biotech industry where the protection of intellectual property is at stake: ·· Drug development, a process lasting potentially up to six years, requires a high degree of confidentiality. ·· Financing rounds are needed for the development of a product as well as for its marketing. Each of these phases carry risks. For instance, in the post-development phase, competitors might want to steal the information to monetise that product, thereby saving time and money. ·· In M&A transactions, the complete company information has to be made available to potential investors and bidders for due diligence. ·· Licence negotiations are highly international projects requiring information to be shared with several outside interests around the globe. ·· Secure storage enables the effective management of company information and of the entire history of product development.

Drooms

De

M

loit

os

te Fa st5

0

t In n ov ativ

Common data-sharing methods, such as email, CDs, or SFTP servers, are risky because they do not encrypt information. A simple but clear safety rule is to make sure the encryption has a 256-bit key length and is Thawte-certified. European cloud providers with servers in Europe should be prioritised for their strong data protection regulations.

e

Defending intellectual property with Drooms NXG

Le

ga

l A quisitio

ns

Sharing knowledge with the KLJKHVW FRQȴGHQWLDOLW\

GURRPV FRP _ RɝFH#GURRPV FRP

With our next generation data room, Drooms NXG, the sharing of information has never been so easy, fast, and secure: ·· Users can access the platform worldwide and simultaneously, with the tool ensuring 99.9% stability and faster document upload speed. ·· The access of every user can be controlled and monitored through detailed reporting, IP address monitoring, dynamic watermarks on each page, and two-factor authentication. Additionally, all data room activity can be reported to the second. ·· Several technical highlights make the workflow more pleasant, i.e. fast upload of documents through “drag and drop” functions, as well as displays in full-screen and split-screen modes. ·· A sophisticated Q&A tool assures that the entire project-related communication does not leave the secure environment of the data room. ·· It combines a high-performing and intuitive interface with thorough and personalised customer support. ·· A dedicated project manager helps to build a relationship of mutual trust around the clock in five languages.

When not tracked, every piece of information leaving a company is under threat. With Drooms, it is possible to control the distribution of confidential documents by the second. We have more than fifteen years of experience and research targeted to building the safest, easiest, and fastest data room environment for the biotechnology industry.

7 th european biotechnology guide 2017

66 | 67

Name · Enzymicals AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Walther-Rathenau-Straße 49a 17489 Greifswald Germany Dr Ute Liebelt +49-3834-515470 +49-3834-515473 info@enzymicals.com www.enzymicals.com 16 2009 l Chemistry and biocatalysis labs l Multipurpose fermentation labs l S1 biotech labs l Genetic engineering labs

Areas of Activity · l Development and production of enzymes l Tailor-made fine chemicals, intermediates, and APIs l Customer specific solutions in enzyme technology, biotransformation, process development, and piloting Biological Patents · IP protected by international patent applications and granted patents External · l BBG Braun Beteiligungs GmbH Collaborations l BRAIN AG l Herbrand PharmaChemicals GmbH l National and international enterprises of fine chemical and pharmaceutical industry l Broad international academic R&D collaboration

Company profile Enzymicals was founded in August 2009 and specialised in providing integrated solutions for biocatalytic applications. The focus of the independent biotechnology SME is the development and production of enzymes, as well as the biocatalytic synthesis of fine and specialty chemicals. Both core areas are combined to find tailor made solutions for custom development and manufacturing.

Products & services Enzymicals offers a broad selection and is an outstanding resource of enzymes suitable for diagnostics, research, and development, as well as for commercial production. Our enzyme portfolio contains a continually expanding biocatalytic toolbox, with innovative biocatalysts from the class of transaminases, monooxygenases, halohydrin dehalogenases, imine reductases, and hydrolases at desired quality grades to solve customer-specific problems at best performance.

We deliver concept-to-completion comprehensive solutions to create and develop high-performance proteinbased products and processes. For this, we discover and produce enzymes based on the demands of our partners. Our technology platform covers the identification of novel enzymes from strain collections and metagenome libraries and their cloning, and functional expression in a range of microbial hosts.

enzymicals

Dedicated to designing, developing and implementing innovative, cost-effective, and scalable chemo-biocatalytic routes to fine chemicals & APIs, Enzymicals offers recognised expertise in the use of enzymatic processes for complex chemical synthesis. We develop scalable strategies for the biotransformational synthesis of your desired compound, which includes feasibility studies, as well as the process development and its piloting.

After identification of a suitable catalyst for the production of your target compound, we can optimise the enzyme via our protein engineering technology to offer the best performance available. Together with our network partners, our service extends to ASMF filing, regulatory affairs, cGMP production, and bulk scale supply.

The combination of best catalysts with optimised chemistry and the integration of processing aspects has enabled us to increase the speed of delivery of effective solutions and expand our business along the entire value chain of the white biotechnology industry.

Management Dr Ulf Menyes (CEO)

7 th european biotechnology guide 2017

68 | 69

Name · Eurofins BioPharma Product Testing Munich GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · ·

Behringstraße 6–8 82152 Planegg near Munich Germany Dr Bettina Katterle +49-89-899-650-0 +49-89-899-650-11 info-munich@eurofins.com www.eurofins.com/pharma-services 1984 GMP/GLP Facilities Testing services for bio-/ pharmaceutical and medical device companies External · BSL BIOSERVICE Collaborations Scientific Laboratories Munich GmbH

Global BioPharma Product Testing within your reach As the largest international network of harmonised GMP product testing labs, Eurofins BioPharma Product Testing delivers a true local service experience.

Eurofins BioPharma Product Testing offers the most complete range of testing services, harmonised quality systems and LIMS to more than 2,000 pharmaceutical and biopharmaceutical companies worldwide.

In our world, global is local Our local presence ensures personal service backed by a unique global breadth of harmonised capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation, and quality control.

With a global capacity of more than 65,000 square metres and 24 facilities located in Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, UK and the US, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. Further, we have teams of scientists placed at more than 60 client facilities throughout Europe and the US through our award-winning Professional Scientific Services (PSS) insourcing programme.

Experience our expertise Eurofins BioPharma Product Testing offers complete testing services for the pharma and biopharma industries, including all starting material, process intermediates, drug substance, drug product, and manufacturing support, as well as broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry, and Microbiology.

Our focus in Germany lies on bioassays/Biacore, microbiology, in vitro toxicology, immuno- and bioanalytical

Eurofins Biopharma Product testing

studies. Additionally we work in close cooperation with BSL BIOSERVICE Munich, an international active contract research organisation, to assess biological safety and activity of bio-/pharmaceuticals and medical devices.

Eurofins BioPharma Product Testing acts as a one-stopshop, covering the whole range from standardised test to special requirements and tailor-made studies with focus on early development as well as release and stability testing strategies for small and large molecules.

Our services for pharmaceuticals, biologics and ATMPs at a glance ·· Toxicology/Pharmacology/Biocompatibility ·· Bioanalytics ·· Immunoanalytics ·· Bio-/Pharmaceutical Lot Release and Stability Testing (GMP) ·· Microbiology ·· Bioassays/Biacore ·· Professional Scientific Services

International presence means global regulatory compliance Operating under the same strict quality procedures, our worldwide laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP) and Japanese Pharmacopeia (JP), as well as specific customer methods.

Our philosophy The fundamental philosophy of Eurofins BioPharma Product Testing is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.

7 th european biotechnology guide 2017

70 | 71

Name · EuropaBio, the European Association for Bioindustries Address/P.O. Box Postal Code/City Country Contact Person

Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · ·

Avenue de l’Armée 6 1040 Brussels Belgium Cosmin Popa (Communications & National Associations Manager) +32-2-739-11-73 +32-2-735-49-60 c.popa@europabio.org www.europabio.org

· · · · · FL I · 15 · 1996 · EuropaBio is the European Association for Bioindustries and was created in 1996 to represent the biotech industry in Europe. EuropaBio’s mission is to promote an innovative and dynamic biotechnology-based industry in Europe.

Our membership is composed of 80 corporate and associate members and bio regions, and 17 national biotechnology associations representing over 1800 European SME biotech companies.

In an independent survey by APCO and EurActiv in 2013, EuropaBio was ranked as the most effective trade association in Brussels.

External · Member of the International Council Collaborations of Biotech Associations Request for · We welcome cooperation with stakeFurther Collaborations holders from industry, European and national policymakers, media, academia and civil society to promote and advance the benefits of biotechnology for European citizens.

The leading voice for biotech in Europe No other industrial sector enhances quality of life, knowledge, innovation, productivity and environmental protection like biotechnology, while also being beneficial for the economy. From new drugs that can address unmet medical needs and fight epidemics and rare diseases, to industrial processes that use renewable feed stocks instead of crude oil, to drought-resistant crops that allow farmers around the world to feed more people under ever-harsher climatic conditions, promoting and investing in biotech pays economic, social and environmental dividends.

For such reasons biotechnology has been a cornerstone of Europe’s competitiveness in terms of research and innovation as well as in terms of industrial growth, number of jobs and new companies created in Member States for numerous years. EuropaBio’s purpose is to ensure this will continue, and that Europe not only remains the world’s biotech research hub, but that European citizens also reap the benefits of innovative biotech products derived from that research.

Driving and sharing industry insights What is required firstly to realise biotech’s potential for and in Europe is sound policy that supports innovation and entrepreneurial risk-taking, together with regulatory structures that reward long-term investment in research and development over short-term gain and quick consumption. To support such policies and structures, EuropaBio set out key recommendations around research and development, assessment and approval, and market access in the industry’s 2014-2019 Manifesto (available online at bit.do/biotechmanifesto).

Fostering biotech awareness Secondly, familiarisation of all parts of society with biotech and how it is helping to create a healthier, greener, more productive, and more sustainable economy is paramount. To this end, EuropaBio showcases these benefits through a wide range of activities and events in the three specific sectors (healthcare, agriculture, and industry) as well as a series of cross-sectoral initiatives such as:

org): a yearly weeklong series of events, activities = $1. >;89.*7 28=.,1 '..4 @@@ +28=.,1@..4 org): a yearly in weeklong events, activities and initiatives Memberseries Statesofexplaining and cel8;0 * B.*;5B @..45870 <.;2.< 8/ .?.7=< *,=2?2=2.< and initiatives in Member States explaining and celebrating biotech across Europe. *7- 272=2*=2?.< 27 .6+.; #=*=.< .A95*27270 *7- ,.5 ebrating biotech across Europe. ¡ The EuropaBio BeneďŹ ts Event features short pres350 million patients Seeking to relieve ¡ .+;*=270 +28=.,1 *,;8<< >;89.

The EuropaBio BeneďŹ ts Event features short presentations

by CEOs of leading biotech companies on 350 million patients already benefiting Seeking to relieve Europabio 20 to 30 million = $1. >;89* 28 .7. =< ?.7= /.*=>;.< <18;= 9;.< entations by CEOs of leading biotech companies 350 patients already benefiting from million treatment Seeking to relieve rareto disease patients 20 30 million concrete examples of where biotech has madeon a .7=*=287< +B < 8/ 5.*-270 +28=.,1 ,869*72.< 87 from treatment already benefiting rareto disease patients 20 30 million concrete examples of society, where biotech has made a positive contribution to as well as â&#x20AC;&#x2DC;testimonifrom treatment rare disease patients ,87,;.=. .A*695.< 8/ @1.;. +28=.,1 1*< 6*-. * Targeted treatments positive to experiencing society, as well as â&#x20AC;&#x2DC;testimonialsâ&#x20AC;&#x2122; fromcontribution end-users on biotech beneďŹ ts for many diseases Targeted treatments 98<2=2?. ,87=;2+>=287 =8 <8,2.=B *< @.55 *< D=.<=26872 50% alsâ&#x20AC;&#x2122; from end-users on experiencing biotech beneďŹ ts ďŹ rst-hand. for many diseases Targeted treatments Insulin, Factor VIII coagulant for haemophiliacs, 50% of all medicines *5<E /;86 .7- ><.;< 87 .A9.;2.7,270 +28=.,1 +.7. =< ďŹ rst-hand. antibodies for cancer, orphan medicinal products for many diseases Insulin, Factor VIII coagulant for haemophiliacs, ¡ EuropaBioâ&#x20AC;&#x2122;s Most Innovative European Biotech SME 50% will from of allcome medicines for rare diseases, vaccines, advanced therapies that antibodies for cancer, orphan medicinal products ;<= 1*7- Insulin, Factor VIII coagulant for haemophiliacs, ¡ Award: EuropaBioâ&#x20AC;&#x2122;s Most Innovative European Biotech SME biotech in from 2015 repair skin, bones and cartilage damagethat will of allcome medicines d[ Vaa bZY^X^cZh a yearly award recognizing European biotech for rareorgans, diseases, vaccines, advanced therapies antibodies for cancer, orphan medicinal products =

>;89* 28E< 8<= 778?*=2?. >;89.*7 28=.,1 # biotech in 2015 repair organs, skin, bones and cartilage damage will come from XVbZ [gdb Award: a yearly award recognizing European biotech for rare diseases, vaccines, advanced therapies that SMEs that have developed innovative solutions to biotech in 2015 repair organs, skin, bones and cartilage damage W^diZX] ^c '%&* @*;- * B.*;5B *@*;- ;.,8072C270 >;89.*7 +28=.,1 SMEs that have developed innovative solutions to ¡¡ The European Biotech Week (www.biotechweek.org): societal challenges. # < =1*= 1*?. -.?.589.- 2778?*=2?. <85>=287< =8 societal challenges. weeklong Forum series of activities and ini¡a yearly The European onevents, Industrial Biotechnology <8,2.=*5 ,1*55.70.< ¡tiatives The European Forum on Industrial Biotechnology in Member States explaining and celebrating and the Biobased Economy (EFIB, www.eďŹ bforum. = $1. >;89.*7 8;>6 87 7-><=;2*5 28=.,178580B and the Economy (EFIB, www.eďŹ bforum. com): anBiobased event providing insight in the exciting and biotech across Europe. *7- =1. 28+*<.- ,8786B @@@ . +/8;>6 AGRICULTURAL BIOTECH com): an event industrial providingbiotech insight landscape in the exciting rapidly evolving that and has AGRICULTURAL BIOTECH ,86 *7 .?.7= 9;8?2-270 27<201= 27 =1. .A,2=270 *7- rapidly evolving industrial biotech landscape that has AGRICULTURAL BIOTECH become a part of the process of building a stronger, ¡¡ The EuropaBio Benefits Event features short presen;*92-5B .?85?270 27-><=;2*5 +28=.,1 5*7-<,*9. =1*= 1*< become a part of the process of building a stronger, more sustainable European biobased economy.

18 million tations by CEOs of leading biotech companies on +.,86. * 9*;= 8/ =1. 9;8,.<< 8/ +>25-270 * <=;870.; Built-in protection farmers more sustainable economy.

18 million concrete examples European of where biobased biotech has made a globally on Built-in protection against insects farmers 68;. <><=*27*+5. >;89.*7 +28+*<.- .,8786B 18 million globally on BEING PART OF THE positive contribution to society, as well as â&#x20AC;&#x2DC;testimoniagainst insects Built-in protection farmers 175 million hectares BEING PART on OF THE globally on against insects hectares 175 million EUROPABIO STORY alsâ&#x20AC;&#x2122; from end-users experiencing Equivalent to Less fuel ! "$ $ biotech benefits EUROPABIO STORY 175 million hectares Our membership is composed of 60 corporate mem7.8 million to first-hand.

Equivalent LessC0fuel and Reduced 2 %" ! #$ "( of 60 corporate memOur membership composed less cars to 7.8 million Equivalent LessC0fuel and Reduced bers, 13 associateismembers and Bio regions, and 17 soil erosion 2 less cars >; 6.6+.;<129 2< ,8698<.- 8/ ,8;98;*=. 6.6 7.8 million bers, 13 associate members and Biowho regions, and 17 and C02 Reduced soil erosion national biotechnology associations, in turnSME repre¡¡ EuropaBioâ&#x20AC;&#x2122;s Most Innovative European Biotech less cars +.;<

*<<8,2*=. 6.6+.;< *7- 28 ;.0287< *7-

soil erosion national biotechnology associations, who in turn repreLess toxins 6% to 30% sent more than award 1800 small and medium sized biotech Award: a yearly recognising European biotech 7*=287*5 +28=.,178580B *<<8,2*=287< @18 27 =>;7 ;.9;.

Less in foodtoxins 6% to 30% more yield sent more than 1800 small and medium sized biotech companies in Europe.

Members of EuropaBio aretoinSMEs that have developed innovative solutions Less in foodtoxins 6% to 30% more yield <.7= 68;. =1*7 <6*55 *7- 6.-2>6 <2C.- +28=.,1 companies in Europe.

Members of EuropaBio are involved in research, development, testing, manufacturin food societal challenges. more yield ,869*72.< 27 >;89. .6+.;< 8/ >;89* 28 *;. 27 volved in research, development, testing, manufacturing and commercialisation of biotechnology products ?85?.- 27 ;.<.*;,1 -.?.5896.7= =.<=270 6*7>/*,=>; ing and commercialisation of biotechnology products and processes.

Our on corporate members have aand wide ¡¡ 270 *7- ,866.;,2*52<*=287 8/ +28=.,178580B 9;8->,=< The European Forum Industrial Biotechnology and processes.

Our corporate members have a wide range of activities: human and animal health care, the Biobased Economy (EFIB, www.efibforum.com):di*7- 9;8,.<<.< >; ,8;98;*=. 6.6+.;< 1*?. * @2-. range of activities: human and animal crop health care, diagnostics, bio-informatics, an event providing insight inchemicals, the exciting andprotection, rapidly ;*70. 8/ *,=2?2=2.< 1>6*7 *7- *726*5 1.*5=1 ,*;. -2 INDUSTRIAL BIOTECH agnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and evolving industrial biotech landscape that has beINDUSTRIAL BIOTECH *078<=2,< +28 27/8;6*=2,< ,1.62,*5< ,;89 9;8=.,=287 agriculture, food and environmental products and services.

INDUSTRIAL BIOTECH come a part of the process of building a stronger, *0;2,>5=>;. /88- *7- .7?2;876.7=*5 9;8->,=< *7- services.

Spares 33 million tonnes Greener transport EuropaBio also welcomes such as more sustainable Europeanassociate biobasedmembers economy.

Spares 33 million tonnes <.;?2,.< Greener transport thanks to biofuels, of CO2 emissions.

EuropaBio also welcomesďŹ nancial, associateasset members such as international commercial, management rubber tyres, Spares 33 million tonnes Greener transport thanks to biofuels, emissions. of CO2Equivalent >;89* 28 *5<8 @.5,86.< *<<8,2*=. 6.6+.;< <>,1 *< to the energy use international commercial, ďŹ nancial, asset management bioplastic parts rubber to tyres, and other companies, thanks biofuels, of CO2Equivalent ofemissions.

2.5 million per use year to homes the energy Being partservice-providing of EuropaBio story regional bio27=.;7*=287*5 ,866.;,2*5 7*7,2*5 *<<.= 6*7*0.6.7= bioplastic parts and other service-providing companies,and regional biorubber tyres, of 2.5 million per use year technology development organisations Equivalent to homes the energy Members of EuropaBio are involved in research, scientiďŹ c develbioplastic parts *7- 8=1.; <.;?2,. 9;8?2-270 ,869*72.< ;.0287*5 +28 of 2.5 million homes per year Materials technology development organisations and scientiďŹ c More effective detergents institutes.

The common denominator among all our opment, testing, manufacturing and commercialisation Materials More allow effective =.,178580B -.?.5896.7= 8;0*72<*=287< *7- <,2.7=2 , to save detergents up to 30% (including plastics) made institutes.

The common denominatorat among all our members is the use of biotechnology any stage Materials More of effective detergents the electricity used on of 27<=2=>=.< $1. ,86687 -.78627*=8; *6870 *55 8>; biotechnology products and processes. Our corpo- of from renewable resources allow to save up to 30% (including plastics) made members is the use of biotechnology at any stage of 30°C laundry by washing at instead of fossil fuels of the to electricity used on research, development manufacturing. from renewable resources allow save up to 30% (including plastics) made rate members have a wideorrange of activities: human 6.6+.;< 2< =1. ><. 8/ +28=.,178580B *= *7B <=*0. 8/ 30°C laundry by washing at on instead of fossil fuels research, development or manufacturing. of the electricity used from renewable resources We lead an innovative diagnostics, and dynamic bio-informatics, industry and memand animal healthcare, laundry by washing at 30°C instead of fossil fuels ;.<.*;,1 -.?.5896.7= 8; 6*7>/*,=>;270 We anthe innovative and dynamic industry and memberslead have opportunity to play an activeand roleenviin EuropaBioâ&#x20AC;&#x2122;s main biotech sector councils (healthcare, chemicals, crop protection, agriculture, food '. 5.*- *7 2778?*=2?. *7- -B7*62, 27-><=;B *7- 6.6 bers have the opportunity to play an active role in EuropaBioâ&#x20AC;&#x2122;s main biotech as sector councils agri-food and industrial), well as in other (healthcare, expert com- ronmental products and services. ;89* 28E< 6*27 +28=.,1 <.,=8; ,8>7,25< 1.*5=1,*;. agri-foodworking and industrial), ascommunications well as in other expert com- +.;< 1*?. =1. 8998;=>72=B =8 95*B *7 *,=2?. ;85. 27 > mittees, groups, initiatives 5 EUROPEAN BIOTECHNOLOGY GUIDE 2015 *0;2 /88- *7- 27-><=;2*5 *< @.55 *< 27 8=1.; .A9.;= ,86 mittees, working groups, communications initiatives 5 EUROPEAN BIOTECHNOLOGY GUIDE 2015 and in developing EuropaBio policy agenda as well EuropaBio also welcomes associate members such as 62==..< @8;4270 0;8>9< ,866>72,*=287< 272=2*=2?.< %" ! $ ( %

and in and developing EuropaBio policy agenda as well events networking opportunities. international commercial, financial, asset management and *7- 27 -.?.589270 >;89* 28 9852,B *0.7-* *< @.55 events and networking opportunities. other service-providing companies, regional biotechnol.?.7=< *7- 7.=@8;4270 8998;=>72=2.< ogy development organisations and scientific institutes.

] ] ]

HEALTHCARE BIOTECH HEALTHCARE BIOTECH HEALTHCARE BIOTECH

EUROPABIO

â&#x2122;Ľ â&#x2122;Ľ â&#x2122;Ľ

TH TH

$

EuropaBio opening the Euronext markets on 27 September 2016

2 \Ă&#x;3 2 \Ă&#x;3 2 \Ă&#x;3

We lead an innovative and dynamic industry and members have the opportunity to develop EuropaBioâ&#x20AC;&#x2122;s policy agenda and to play an active role in our main biotech sector councils (healthcare, agri-food and industrial), expert committees, working groups, and communications initiatives including events and networking opportunities.

7 th european biotechnology guide 2017

72 | 73

Name · Evotec AG

Address/P.O. Box · Manfred Eigen Campus Essener Bogen 7 Postal Code/City · 22419 Hamburg Country · Germany Contact Person · Gabriele Hansen VP, Corporate Communications & Investor Relations Telephone · +49-40-56081-255 Fax · +49-40-56081-222 Email Address · info@evotec.com Internet Website · www.evotec.com Social Media · L I Number of Employees · >1,200 (as of 31 December 2016) Founded (year) · 1993 Type of Laboratory · l Chemical

Areas of Activity ·

Annual Turnover · Relevant R&D Budget · Biological Patents ·

External · Collaborations

l Biological l Cell culture S1, S2 Drug discovery and development alliances as well as proprietary research with focus on CNS/neurology, diabetes and complications of diabetes, pain and inflammation, oncology and infectious diseases €127.7m (2015) €18.3m (2015) A broad portfolio of patent families relating to compounds, targets, and assays. Evotec has nearly 80 patent families under its full control.

The company is now working with more than 250 Pharma and biotech companies, not-for-profit organisations and foundations on a global basis.

Request for · Our team of business development Further Collaborations managers would be happy to discuss our R&D solutions, in- and outlicensing opportunities and how we can assist you in meeting your needs in drug discovery and development.

For more information, please contact us at info@evotec.com.

Company profile With its 23-year corporate history, Evotec is a drug discovery partnership company providing drug discovery solutions to pharmaceutical and biotechnology companies, academic institutions, as well as to foundations and not-for-profit organisations. With a large pool of highly experienced scientists, state-of-the-art technology platforms, first-class scientific operations, and key therapeutic expertise in the areas of neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, and infectious diseases, Evotec aims to identify and develop best-in-class and first-inclass differentiated therapeutics for collaborators or for its own internal pipeline development.

Today, Evotec drives research and development projects in numerous alliances and partnerships with Pharma and biotech companies as well as academia. Its strategy follows a clear goal: achieving the leadership position in high-quality drug discovery solutions and building a partnered product pipeline based on the highest-quality drug discovery science and innovative collaborations.

Evotec AG is a publicly listed stock corporation operating under German law, with headquarters in Hamburg, Germany. Including the newly acquired Cyprotex sites, additional major operating sites in the UK, Germany, the USA, and France handle Evotec’s international business development activities, which are closely integrated with the Group’s operations. Evotec has more than 1,200 employees worldwide.

Building on this expertise in the field of drug discovery services, the Company has evolved into a drug discovery engine in its own right, with its two business segments EVT Execute and EVT Innovate.

EVT Execute – speed, expertise, and new technologies The EVT Execute segment provides stand-alone or integrated drug discovery solutions for collaborators’ targets and programmes on a typical fee-for-service basis or through a variety of commercial structures including research fees, milestones, and/or royalties.

Evotec

Projects are selected to match Evotec’s expertise and technology. In these projects, EVT Execute contributes efficiency, project management, and speed in the drug discovery process. The Company is continuously upgrading its platforms in building a systematic, unbiased, and comprehensive discovery platform accessible to its customers, partners, and academic institutions alike.

Furthermore, new licences (e.g. Trianni, CRISPR) are enhancing Evotec’s platform.

EVT Innovate – source of new pipeline entries The EVT Innovate segment focuses on investing and developing its own internal assets, including early-stage discovery programmes as well as more advanced drug candidates, which are subsequently positioned for partnering with Pharma companies. EVT Innovate partnership agreements usually include upfront and research payments as well as milestones and product royalties. Evotec’s internal programmes focus on firstin-class and best-in-class projects based on innovative biology. These so-called Cure X or Target X initiatives largely follow indication areas that are firmly established at Evotec. Projects are also selected to optimally leverage Evotec’s drug discovery platform. Over the last five years, Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility, and robustness, to reach the highest industrial standards.

Discovery and development alliances Evotec has been involved in more than 250 partnerships since its inception in 1993 and has delivered more than 30 pre-clinical candidates and 20 clinical candidates both in partnerships and within its own proprietary drug discovery efforts. Evotec’s partners consist of the Top 20 pharmaceutical companies, many biotechnology and mid-sized pharmaceutical companies, academic institutions, foundations, and not-for-profit organisations.

7 th european biotechnology guide 2017

74 | 75

Name · FILTROX AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Moosmühlestrasse 6 9001 St. Gallen Switzerland Ralph Daumke +41-71-272-9111 +41-71-272-9100 r.daumke@filtrox.ch www.filtrox.com ~ 250 1938 Microfiltration and treatment of high value liquids | Depth filtration | Single-use cell removal | Activated carbon filter

External · | ZHAW Wädenswil, Switzerland Collaborations | FH Trier, Bioverfahrenstechnik, Prof. Kampeis, Germany | HES-SO, Institute of Lifetechnology, Switzerland Request for · Partners for business and Further Collaborations product development

As a global market leader in microfiltration, FILTROX offers complete solutions for filtration of high-value liquids. We are experts in the development, manufacturing, and supply of Swiss top-quality products for a wide range of applications in pharmaceuticals, biotechnology, chemicals, and cosmetics, as well as in food and beverages. Since 1938, we have been developing and manufacturing filter media and filtration equipment inhouse.

Based on this experience, we can offer our customers a complete range of products.

FILTROX’s worldwide distribution network and comprehensive technical support will help you optimise your filtration process.

Products Depth filter sheets and lenticular filter modules: PURAFIX® filter sheets and lenticular filter modules with low ion and pyrogen content for pharmaceutical/biotech applications.

FIBRAFIX® filter sheets and lenticular filter modules for raw materials and food & beverage applications SYNTHAFIX TM filter sheets and lenticular filter modules for application with high-enzymatic reactions or for the filtration of aggressive chemicals.

CARBOFIL®: activated carbon filter sheets and lenticular filter modules for decolonisation of liquids.

Plate and frame filters and module housing: NOVOX® plate and frame filters in sizes of 200x200mm and 1200x1200mm depth filter sheet size.

DISCSTARTM housing offers a closed system for filtration SECUROX® housing for use with cartridge filters FILTRODISCTM BIO SD Single-use depth filters for cell removal Also used for highly toxic applications and removal of activated carbon powder

Filtrox

Service ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Process development and optimisation Laboratory trials Field tests Scale-up support Validation support FILTROX Academy Filtration seminars Individual trainings Filtration audits Spare parts service Upgrading of existing equipment Customer service Commissioning

Locations FILTROX AG St. Gallen, Switzerland: Headquarters of the FILTROX Group, with manufacturing facilities for depth filter media (filter sheets and modules) as well as filtration equipment.

FILTROX North America, USA: Sales Office FILTROX MICRO FILTRACIONES, SA de CV, Mexico: Sales Office FILTROX (Shanghai) Filtration System Co., Ltd., China: Sales Office and logistics centre FILTROX UK & Northern Europe, Barnoldswick, UK: Sales Office FILTROX Southern Europe, Sant Adrià de Besòs, Spain: Sales Office FILTROX France s.a.r.l., Beaune, France: Sales Office FILTROX Asia-Pacific Pte. Ltd., Singapore: Sales Office

7 th european biotechnology guide 2017

76 | 77

Name · Fundación MEDINA

Address/P.O. Box · Avda Conocimiento 34, Health Sciences Technology Park Postal Code/City · 18016 Granada Country · Spain Contact Person · Dr Olga Genilloud Telephone · +34-958-993-965 Fax · +34-958-846-710 Email · olga.genilloud@medinaandalucia.es Website · www.medinadiscovery.com Social Media · FL  Number of Employees · 38 Founded (year) · 2008 Type of Laboratory · Non-profit research organisation Areas of Activity · l Natural products drug discovery: infectious and parasitic diseases, cancer, neurodegenerative rare diseases l Natural products microbiology: microbial diversity, fermentation and secondary metabolism, genome mining, and metagenomics l Natural products chemistry: isolation and structural elucidation, analytical profiling l ADME and Bioanalytics: pharmacokinetics, early safety, toxicology l Metabolomics and biomarkers External · Pharma and biotechnology companies Collaborations in human health, agri-food and cosmetics; academic centres, universities and hospitals; EU consortia and PPPs Request for · New collaborations/business opportuFurther Collaborations nities in the discovery of novel drug leads and enzymes with applications in pharma and other industrial sectors (crop protection, agri-food, and cosmetics). New partners in synthetic biology with genome mining interests to explore MEDINA’s microbial collections.

Member of

European Biotechnology NET WORK

Fundación MEDINA is a non-profit public-private partnership between Merck Sharp & Dohme de España S.A., the Regional Government of Andalucía, and the University of Granada to discover innovative compounds and therapies for unmet medical needs.

MEDINA was established in 2008 in the Health Sciences Technology Park in Granada from the former Basic Research Centre of MSD de España (CIBE-MSD) in Spain, one of the longest operating and most successful natural products (NPs) drug discovery programmes in the pharmaceutical industry.

Leveraging this industrial-derived experience, highly qualified research team and cutting-edge technology platforms, MEDINA is a Centre of Excellence for research and development in drug discovery and highvalue biotechnology products. MEDINA scientists have been attracted from the pharmaceutical, biotech, and academic sectors, and they operate as part of a multidisciplinary team with skills in molecular and cell biology, industrial and clinical microbiology, informatics and automation, compound management, analytics, and NPs chemistry.

“Natural products are pivotal in inspiring chemists and providing innovative chemistry for novel therapeutic agents.”

MEDINA is an internationally recognised leader in drug discovery from microbial natural products. MEDINA makes available for screening one of the world’s most productive and diverse collections for discovery of NPs (more than 190,000 strains and a library of 135,000 extracts) and for mining for new genes and unique enzymes with broad biotechnological applications.

MEDINA focuses its discovery programmes on the search for novel drugs for infectious and parasitic diseases, oncology and immunomodulation, neurodegeneration, and rare diseases. MEDINA has extensive experience in high throughput screening (HTS) with libraries of microbial NPs extracts and synthetic compounds in a large diversity of formats, and is currently developing collaborative research in all these areas with internal or competitive funding from national and European programmes.

fundación MEDINA

MEDINA is developing unique NP library modules in source diversity and chemical space, to be used in drug discovery. Based upon our record of identifying druglike compounds from microorganisms, we offer opportunities to discover neglected and novel scaffolds unknown in synthetic libraries. MEDINA offers to its partners in the scientific community and the pharmaceutical, biotechnology, cosmetics, and agrochemical sectors access to a unique platform for NPs discovery derived from a superbly diverse microbiological arsenal.

MEDINA is developing internal and collaborative drug discovery research programmes with international academic institutions, biotechs and big Pharma.

MEDINA is actively seeking to establish collaborative agreements that could bring lead candidates into the preclinical stage: “Our public-private model offers a privileged position to establish successful partnering relationships with research groups in the academic and biopharmaceutical sectors”.

MEDINA provides contract research services including access to its libraries and the NP drug discovery platform with expertise in HTS and structural elucidation of complex small molecules, and a high throughput preclinical ADME/safety platform for the evaluation of potential cardiovascular liabilities and adverse drug metabolism effects and PKPD of early development drug candidates.

MEDINA bioanalytical and metabolomic platforms perform both discovery and new biomarkers identification studies in collaboration with international research communities. The LC-MS platform allows high throughput analysis of liquid and tissue biopsies from clinical and animal models samples, as well as plant and microbial extracts. Statistical analysis and predictive models are applied for patient stratification and to identify metabolic pathways involved in key biological processes.

7 th european biotechnology guide 2017

78 | 79

Protein expression technologies

Name · Geneva Biotech

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Founded (year) Type of Laboratory

· · · · · · · · · ·

La Tulipe, Avenue de la Roseraie 64 1205 Genève Switzerland Daniel Fitzgerald +41-22-372-38-33 +41-22-594-81-42 contact@geneva-biotech.com www.geneva-biotech.com 2012 Molecular Biology and Cell Culture

Biological Patents · 4 External · SME and University Collaborations Request for · SME and University Further Collaborations

The development of recombinant protein expression technologies was one of the first offshoots of the DNA cloning revolution that was initiated in Stanford University in the 1970’s. Advances in recombinant DNA protein production technologies were responsible for subsequent groundbreaking shifts in the way the pharmaceutical industry carried out discovery, and more recently biopharmaceutical manufacturing, led by cutting edge methodologies to both discover and manufacture fully humanised monoclonal antibodies.

Geneva Biotech company vision Technical limitations in today’s protein production technologies rules out the development or production of a wide range of potential products, or renders them prohibitively expensive. Geneva Biotech’s vision is to develop a portfolio of intelligent protein expression technologies- focusing on biotechnology and industrial biotechnology applications, taking advantage of the latest enabling tools of synthetic biology. Geneva Biotech specialises in developing multiprotein expression technologies – meaning heterologous DNA production codes that enable e.g. simultaneous production in one cell of whole metabolic pathways.

University spinoff Geneva Biotech was founded in 2012 as a spinoff of the European Molecular Biology Laboratory (EBML).

Member of

European Biotechnology NET WORK

Geneva Biotech

Technology solutions Geneva Biotech markets protein production platform technologies across the full spectrum of popular host cell types, and specialises in delivery of solutions for high degree of difficulty protein production problems.

Traditional technologies do not allow for convenient coexpression of multiple proteins in a single cell. Multiprotein expression is used to produce protein complexes, such as multivalent vaccines, or multiple individual proteins in the same cell, such as for signaling pathways used in drug discovery. Multiprotein expression systems are also the key enabling technology for the synthetic biology industry, where heterologous metabolic pathways are created to produce a wide variety of molecules, from industrial chemicals to biofuels.

Platform technologies MultiBac™ uses DNA recombination to allow for easy, high-throughput compatible construction of baculovirus vectors for multiprotein expression in insect cells.

MultiMam™ Stable and MultiMam™ Transient are modular plasmid-based DNA recombination systems for generating stable or transiently expressing mammalian cell lines. MultiColi™ is a multiprotein expression system for bacterial cells. MultiBacMam™ is a gene delivery system for mammalian cells, which allows for rapid, recombination based assembly of DNA cargoes of up to 40 kbp. Geneva Biotech markets kits of these and other protein expression technologies to academic and non-commercial users. The company issues licenses for the technologies to commercial users as single site or multisite nonexclusive sublicenses.

7 th european biotechnology guide 2017

80 | 81

Name · HealthCapital – Cluster Healthcare Industries Berlin-Brandenburg Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Email Website Social Media Areas of Activity

· · · · ·

Fasanenstr. 85 10623 Berlin Germany Dr Kai Bindseil, Clustermanager HealthCapital Berlin-Brandenburg +49-30-46302-463 info@healthcapital.de www.healthcapital.de L #HealthCapitalBB l Technology transfer between science and industry l Initiation and support of networks l Support for technology-oriented start-ups l Funding support for innovative project concepts l Providing and presenting regional life sciences information l Building and coordinating of scientific and interdisciplinary networks l Establishing contacts between experts from all disciplines l Organisation of events and seminars, Public Relations work for the life sciences region

External · l Member of the Council of European Collaborations Bioregions l ScanBalt and European Diagnostic Clusters Alliance l Cooperation Platform with the Region Cheongchungbuk-do, Korea (Chungbuk Technopark) l Member and contact point in Berlin for Enterprise Europe Network (EEN) l Collaborations with European Life Science clusters and SMEs in several FP6 and FP7 projects and other activities

The Berlin-Brandenburg BioRegion … … a Leading Hub for Life Sciences The Berlin-Brandenburg region is one of the leading, international locations for life sciences. The area concentrates on clinical research via a dense and compact healthcare network, and boasts a state-of-the-art IT infrastructure. It is no coincidence that the region is Germany’s ‘health capital’ as it is home to both the German government, as well as the centre for healthcare industries.

The region’s distinction is anchored in its unique research and clinical landscape, as well as its ability to closely link the key players in the life sciences and healthcare. Biotechnology, in particular, is a strong driving force within the Berlin-Brandenburg healthcare industries cluster – HealthCapital – generating innovation and growth there and beyond. Through networking the pharmaceutical, diagnostics and medical technology sectors completely new fields of business are created.

More than 240 biotechnology and around 30 pharmaceutical companies are located in the German Capital Region. They include market leaders like Bayer AG, Bausch & Lomb, B. Braun Melsungen, Berlin-Chemie, Pfizer, Sanofi and Takeda. Along with the sector’s many small and mid-sized companies, they benefit from close cooperation, both with science and with more than 130 hospitals – above all, one of Europe’s largest university hospitals: Charité – Universitätsmedizin Berlin. Customers from research and industry have access to patient cohorts of urban and rural populations of about 180 ethnicities, covering all medical indications. The many technology parks and networks in the various branches of modern biotechnology create the excellent infrastructure and technological support that characterize the Berlin-Brandenburg life sciences area. Focus of biotech activity within the region are biomedicine and diagnostics, therapeutics and regenerative medicine as well as industrial biotechnology.

HealthCapital

… connected to the European Hotspots Active cooperation in the networks of Europe’s BioRegions has played a central role in the internationalisation efforts in the region. The region is a member of the Council of European Bioregions (CEBR) and ScanBalt – the biotech network of the Baltic Sea states. Through the Center for Molecular Diagnostics and Bioanalytics (ZMDB), the region is also a member of the European Diagnostic Clusters Alliance (EDCA), a network of leading European diagnostics clusters. Berlin-Brandenburg is regarded as one of the most high-performing regions in the alliance as regards both the number of companies and research facilities engaged in diagnostics development and the structures already established here.

… offering Service and Support for Life Sciences in the Capital Region The central contact and coordination office for all issues concerning life sciences in the German Capital Region is HealthCapital. At the interface of business, science and clinics, the HealthCapital cluster management drives networking and the technology transfer and supports companies interested in relocating to the region.

Berlin Partner for Business and Technology and ZAB Brandenburg Economic Development Board are responsible for managing the cluster.

Meet us 2017! conhIT, April 25–27, Berlin BIONNALE, May 17, Berlin BioJapan, October 11–13, Yokohama BIO-Europe, November 6–8, Berlin Medica, November 13–16, Düsseldorf

BERLIN – the place to be for BIO-Europe 2017

7 th european biotechnology guide 2017

82 | 83

Name · Heidelberg Pharma GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · ·

Schriesheimer Str. 101 68526 Ladenburg Germany Prof. Dr Andreas Pahl +49-6203-1009-0 +49-6203-1009-764 a.pahl@hdpharma.com www.heidelberg-pharma.com 48 2004 l Chemistry l Molecular biology l Pharmacology l Bioanalytics

Areas of Activity · l Drug development l ADC technology platform l Provider of preclinical services Request for · Antibodies with high specificity Further Collaborations to conjugate with Amanitin, ADC collaborations

Company profile The biopharmaceutical company Heidelberg Pharma GmbH is a wholly-owned subsidiary of WILEX AG, which is listed on the Frankfurt Stock Exchange.

ADC technology platform Heidelberg Pharma is developing the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugates (ATAC) technology. Amanitin has a unique biological mode of action which could be used as the basis for developing highly effective, innovative drugs. Amanitin is a member of the amatoxin group of natural poisons, which occur in the death cap mushroom (Amanita phalloides). It works by selectively inhibiting RNA polymerase II, which results in apoptosis. All other chemotherapy drugs used to date, including other Antibody Drug Conjugates (ADC), either function as what are known as “spindle poisons” (tubulin inhibitors) or work via binding to DNA, which makes them dependent on cell division. RNA-Polymerase II inhibition is a novel principle in cancer therapy and offers the possibility of breaking through drug resistance or destroying dormant tumour cells, which could produce major clinical advances.

This proprietary technology platform is being applied to create a variety of ATAC candidates in third-party collaborations as well as to develop the Company’s own therapeutic ATAC pipeline.

Heidelberg Pharma is granting licenses for ATAC technology and its application on antibodies provided by customers. Integrated into license agreements, toxin linker prototypes will be made available, conjugated to their antibodies and tested biologically. Heidelberg Pharma also provides its partners technological support in the manufacturing and purification of the conjugates, the production and delivery of the compound, as well as selected preclinical research necessary in relation to designing, optimising, profiling, and manufacturing new ATACs.

Heidelberg Pharma

In product partnerships, Heidelberg Pharma contributes the toxin linker technology to the cooperative partnership as a contribution in kind, while other biotechnology companies contribute antibodies or innovative antibody formats. Together, novel ATACs will be developed up to preclinical stage, in which their efficacy and tolerability can be meaningfully assessed. A decision will later be taken with the partner in question as to whether joint clinical development is possible or whether direct licensing or sale of the product to third parties is preferable.

In addition to collaborating with partners, Heidelberg Pharma is increasingly working on the development of its own ATAC candidates. It has begun to develop its lead ATAC product candidate, HDP-101, for multiple myeloma using a BCMA-antibody. Strong efficacy and good tolerability of this candidate have already been demonstrated in several animal models. The data available thus far confirm the hope that the advantages of products based on Amanitin can be transferred also to specific ATACs for use in different cancer indications.

Preclinical services business The Company also has the expertise and required infrastructure for in vivo pharmacology and bioanalytics, and offers preclinical research services in the fields of cancer, as well as inflammatory and autoimmune diseases.

Its services are focused on early-stage research (e.g. lead structures to be optimised) up to the profiling of preclinical candidates.

7 th european biotechnology guide 2017

84 | 85

Name · IBA GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Rudolf-Wissell-Str. 28 37079 Göttingen Germany Dr Wolf Jockusch +49-551-50672-0 +49-551-50672-181 info@iba-lifesciences.com www.iba-lifesciences.com

FL I G >50 1990 S1 l Cell Selection & Expansion l Protein Production & Assays l Custom Oligos & Predefined DNA/RNA

Biological Patents · l Strep-Tactin®XT l Strep-Tactin® l Twin-Strep-tag® l Streptamer ® External · Numerous in- and out-licensing Collaborations contracts Request for · Further distributors worldwide; mamFurther Collaborations malian expression systems/vectors; peptide tags for handling and delivery of proteins; diagnostic and therapeutic as well as HTS applications for existing products

IBA GmbH – Solutions for Life Sciences For more than two decades IBA has provided innovative technologies for life sciences applications, including tools for cell selection & expansion, protein production & assays, and custom oligos & predefined DNA/RNA.

Product portfolio Cell selection & expansion Automated cell selection via TACS technology directly from whole blood is possible using IBA’s design awardwinning FABian® device. Customised protocols depending on the cell type, the sample volume, and the intended yield allow for convenient fully automatic cell isolation. Strep-tagged Fab fragments (Fab-Streps®) reversibly capture and release the target cells during the selection process. This delivers label-free, non-activated target cells in a standardized man­ner of highly reproducible quality. Isolated cells are suitable for all further immunological or cell biological investigations, including cell-based diagnostics or assays, e.g. pharmacological analysis of drug levels in the isolated cell fraction. As an alternative to FABian® we offer gravity flow columns for manual cell selection based on the same technology.

For T cell stimulation, we offer completely novel reversible reagents, the Streptamers® for cell expansion, which provide unique flexibility for cell research.

Protein production & assays The Strep-tag® technology is IBA’s proprietary and versatile protein purification, detection, and immobilisation platform. It is one of the most widely used systems for affinity purification, providing exceptionally pure proteins.

Recently the third generation of the Strep-tag® system was launched, based on the new Strep-Tactin®XT and Twin-Strep-tag®. Strep-Tactin®XT is a further developed Strep-Tactin® with extra tight binding to Twin-Strep-tag®, which now enables Strep-tag® technology to be used in applications where extra tight binding is a requirement.

With this feature, the third generation Strep-tag® technology now enters the field of assay development and screening, opening new possibilities in the pharmaceutical and biotech sector for, e.g. screening of new diagnostic targets and the development of diagnostic assays.

IBA

Custom oligos & predefined DNA/RNA IBA’s nucleic acid division focuses on specialised nucleic acid custom services. The tailor-made DNA and RNA oligonucleotides, including modified and labelled nucleic acids, require particular care in synthesis and are of the highest quality. Applications can be found in e.g. real-time PCR, FRET, gene silencing studies, immobilisation, FCCS, or high-resolution microscopy. The innovative Click Chemistry enables additional dye combinations with unsurpassed labelling densities. More than 200 fluorescent labels and more than 80 modifications are available. With our expertise, we can also produce custom DNA and RNA aptamers according to your individual specifications.

Business model ·· Development and commercialisation of proprietary products that are marketed worldwide ·· Contract service activities based on IBA’s innovative technologies ·· Licensing products and/or technology for research, diagnostics, and therapy ·· Serving international markets through a network of distributors and the IBA US Distribution Center

People Dr Mike Rothe (Chief Executive Officer) Dr Joachim Bertram (Chief Scientific Officer) Dr Herbert Stadler (Head of the Advisory Board)

7 th european biotechnology guide 2017

86 | 87

Name · Infrapark Baselland AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Rothausstrasse 61 4132 Muttenz Switzerland Dr Gaudenz Furler +41-61-469 75 85 +41-61 469 59 49 info@infrapark-baselland.com www.infrapark-baselland.com 180 2011 Chemical park

Infrapark Baselland AG is offering real estate and services to the chemical and life science industries. The site is ideally located close to Basel in the centre of Europe.

To date 18 companies active in the field of the production and development of specialty chemicals are based at Infrapark.

Basel region: one of the world’s leading destinations in life sciences Basel is one of the most dynamic economic regions in the world. In the Basel area you will find an enormous concentration of innovative companies involved in the life sciences and many research groups from renowned research institutes worldwide, an open-minded culture, an international environment, business-friendly conditions, and a quality of life that will fulfill the most stringent requirements.

Excellent network to life sciences and biotech industries and research institutes Thanks to the network of Infrapark, companies located in our chemical park can tap an unrivalled life sciences/ biotech talent pool. The Basel area is home to worldfamous life sciences and chemical companies, making the Basel region one of the most successful life sciences locations in the world. More and more companies are developing not only chemical but also biological processes for the manufacturing of active ingredients.

This includes the big global companies in the Basel region, namely Novartis, Roche, and Syngenta, but also companies like Actelion, Basilea, Evolva, Bachem, etc., as well as promising biotech and start-up companies.

Real estate offer of Infrapark Infrapark provides the chemical and life sciences industry with 32 hectares of outstanding developed real estate. Besides existing buildings, which can be converted to meet actual demand, around 5 hectares of free plots are available to interested companies.

Infrapark baselland

Custom-tailored services To allow customers of Infrapark to concentrate on their core business activities, we provide a comprehensive range of services: ·· Facility management ·· Utilities (energy products and resources) ·· Waste disposal (incineration of solid, liquid, as well as gaseous waste, including source exhaust air, unique waste water pretreatment) ·· Health, safety, and environment: Experts provide solutions-led advice to our customers for their individual projects, as well as support the completion of the groundwork and documents required to ensure the viability of their investment planning for submission to the authorities ·· Analytics (with ISO 17025 accreditation) ·· Logistics (storage & handling of hazardous & dangerous goods) ·· Technical services (engineering, repair, and maintenance)

Our Services > Facility Management > Utilities > Waste Disposal > Waste Water Pretreatment AVORA > Analytical Services > Logistics > Health, Safety, and Enrivonment > Engineering > Workshops

Speed According to our customers, one of the decisive factors in basing their enterprise at Infrapark site Muttenz is the speed with which they can realise their business, wether obtaining a permit to start construction of a production building or a permit to start manufacturing chemical products. Compared to other European locations the authorities show a pragmatic approach in dealing with special requests and are very familiar with the processes in the chemical and pharmaceutical industry.

Infrapark: home for the chemical, pharmaceutical, and biotech industry In summary, the chemical park Infrapark Baselland offer, all the advantages that are well known from other chemical parks in Europe but with the added benefit of a very pro-business environment. In addition, hardly any other region in the world demonstrates a comparable concentration of industrial companies and research institutes in the chemical and life sciences industries like Basel. The chemical, life sciences, as well as biotech industries are at home here – and at Infrapark Baselland.

7 th european biotechnology guide 2017

88 | 89

I

Intravacc is a renowned, not-for-profit R&D organisation with 100+ years’ experience in vaccine development. We optimise vaccines, vaccine processes, and vaccine technologies. Our aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

We accomplish this through strategic collaborations with academia, public health organisations (WHO/BMGF) and biotech and pharmaceutical companies.

150 Institute for Translational Vaccinology

Viral vaccine technology

Name · Intravacc

Address/P.O. Box Postal Code/City Country Telephone Email Address Internet Website Social Media Number of Employees Type of Laboratory

· · · · · · · · ·

Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven The Netherlands +31-30-7920-300 info@intravacc.nl www.intravacc.nl

Biological Patents · On request External · On request Collaborations

Our viral vaccine platform is based on Intravacc’s established and well-characterised WHO pre-qualified Vero cell line. For new viral vaccine development, we use a scalable platform production process based on an available scale-down process for IPV. Our proven technology is based on Intravacc’s long-standing experience with oral and inactivated poliovirus vaccines and includes the recovery of virus seed strains from synthetic viral genomes, cell and virus culture technology, virus harvest and clarification, purification, formulation, and freeze-drying, with all analytical assays required for inprocess controls and product release. In this way, proofof-principle of a pilot process for various viral vaccines, as recently shown for Sabin-IPV, OPV, RSV, EV71, and Rota vaccine concepts, can be demonstrated quickly using a science-based quality by design approach.

Bacterial vaccine technology For the development of vaccines against bacterial pathogens, Intravacc has developed, alongside conjugate vaccine technologies, a strong platform based on outer membrane vesicles (OMVs). OMVs are spherical particles with natural adjuvant properties that harbour many antigens. Using genetic engineering, the OMVs can be decorated with the desired antigen(s) in the required amounts that maintain their native conformation.

Heterologous OMVs are a suitable alternative for pathogens that require a high containment, that are difficult to cultivate, or that contain viral and/or parasitic proteins. The antigens of choice are placed in an “empty” OMV. We have developed genetic tools to in-

intravacc

crease yield, reduce toxicity, and achieve the desired antigenic composition. A robust scalable GMP compliant production process is in place.

Vaccine development chain Discovery

Preclinical

Research

Process & Assay Development, Scale-up

Phase I

Phase II

Phase III

Animal Models (Pilot) ProducƟon, Quality Control & Quality Assurance

Licensure

Vaccine design Our broad technological capabilities, including (physico-) chemical analyses, molecular biology, proteomics, immunological read-out, mass spectrometry, and production techniques – allow us to guide your innovative vaccine concept through the development chain. Special focus points are vaccine delivery and vaccine formulation.

Clinical & Regulatory

Intravacc

As a front runner in applied research on mucosal and intradermal delivery we can create value with promising delivery technologies. Our formulation team can help to produce safe, affordable vaccines by using the right ingredients. The production of combination vaccines, lyophilisation and spray-drying, stabilisation, and the use of proprietary adjuvants (like modified aluminum and our detoxified LPS mutants) can serve to complement your concept.

Animal models and 3Rs Intravacc has three state-of-the-art animal facilities for housing different species of experimental animals, e.g. (transgenic) mice, rats, cotton rats, ferrets, guinea pigs, rabbits, etc. In addition it is Intravacc’s ambition to replace the use of animals for routine lot release testing of vaccines with innovative animal-free techniques and to improve the scientific substantiation of these methods.

Therefore Intravacc has developed several methods based on the 3R’s (reduction, refinement, & replacement).

If you want to know more about our products, services, and opportunities, please contact us.

7 th european biotechnology guide 2017

90 | 91

Name · Information Processing Laboratory

Address/P.O. Box · Dpt. of Electrical and Computer Engineering Faculty of Engineering, Building C, Aristotle University of Thessaloniki Postal Code/City · 54124, Thessaloniki Country · Greece Contact Person · Dr Fotis E. Psomopoulos Telephone · +30-2310-99-6359, +30-6977-722-856 Fax · +30-2310-99-6398 Email · fpsom@issel.ee.auth.gr Website · ipl.ee.auth.gr Number of Employees · 20 Founded (year) · 2001 Type of Laboratory · Academic Laboratory (in silico research) Areas of Activity · | Bioinformatics | Databases and Knowledge Discovery | Intelligent Software Agents and Multi-agent Systems | Software Engineering | Semantic Web Technologies | Environmental Informatics | Intelligent Image and Video Processing and Analysis | Semantic Multimedia Analysis and Retrieval | Sensor-based analysis of human behavior | Big data analytics for medical applications | Biomedical Knowledge Bases | Extraction of 3D Shape from Motion External · | Centre for Research and Technology Collaborations Hellas | EGI (European Grid Infrastructure) | I nventeurs du Monde Numérique (INRIA) | Instituto de Tecnologia Química e Biológica (ITQB) | Karolinska Institute IPL is looking for partners among Request for · Academic Institutions and SMEs that Further Collaborations are willing to help us achieve our mission and research goals Member of

European Biotechnology NET WORK

The Information Processing Laboratory (IPL) belongs to the Department of Electrical and Computer Engineering, in the School of Engineering of the Aristotle University of Thessaloniki and consists of two labs, the Intelligent Systems and Software Engineering Lab (ISSEL) and the Multimedia Understanding Group (MUG). IPL is an active research group in the intelligent systems field, with interests covering a wide range of artificial intelligent applications and a significant focus on bioinformatics algorithms and their deployment on large scale computational infrastructures (such as the European Grid Infrastructure). Moreover, IPL has recently established a quality management system with the scope of “Software Development for Information Processing and Data Analytics” that is in conformance with the International Standard EN ISO 9001:2008.

ISSEL, headed by Prof. Pericles Mitkas, includes Assistant Professor Dr. Andreas Symeonidis, four postdoctoral researchers, six PhD students and a number of technical/programming staff members. The group’s R&D activities have been in the areas of: ·· Bioinformatics ·· Software Engineering ·· Energy/Smart Grids ·· Intelligent Agents ·· Robotics ·· Semantic web & linked data ·· Social network analysis ISSEL provides expertise in theoretical and technical issues regarding the design and development of agentbased software and agent-based simulations for decision support, semantic storage, querying and integration of knowledge sources and data mining techniques for knowledge extraction.

MUG, headed by Associate Professor Anastasios Delopoulos, is teamed by a postdoctoral researcher, five PhD students and a number of technical/programming staff members. Its R&D activities lie in the areas of: ·· Sensor-based analysis of human behavior ·· Big data analytics for medical applications ·· Intelligent Image and Video Processing and Analysis

IPL

·· ·· ·· ··

Multiple-Cue Human-Computer Interaction Semantic Multimedia Analysis and Retrieval Biomedical Knowledge Bases Extraction of 3D Shape from Motion

The group also has long experience in projects involving the design of algorithms, methods and systems in the broader areas of computer vision, signal processing and machine learning for applications such as multimedia search engines, knowledge extraction from medical databases, behavioural monitoring and analysis and decision support systems.

Mission ·· ·· ·· ··

Research – Development – Innovation High Quality Scientific Research Collaboration with Research Centres and Universities Collaboration with the International & National Industry

Research goals The development, assessment and the standardisation of innovative research and educational product systems and services, as well as the creation of spin-offs for the support and uptake of innovative applications and products in Information Technology form the basic research goal of IPL.

Some indicative European and national projects ASSIST: Association Studies Assisted by Inference and Semantic Technologies Funding: European Commission, IST-4-027510-STP Duration: 01/2006–12/2008, IPL Role: Project Coordinator SPLENDID: Personalised Guide for Eating and Activity Behaviour for the Prevention of Obesity and Eating Disorders (splendid-program.eu) Funding: European Commission, FP7 Program Duration: 10/2013–09/2016, IPL Role: Project Coordinator S-CASE: Scaffolding Scalable Software Services Funding: European Commission, FP7 Program (scasefp7.eu), Duration: 11/2013–10/2016, IPL Role: Project Coordinator 7 th european biotechnology guide 2017

92 | 93

Name · IRBM

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

via Pontina km 30600 00071 Pomezia Italy Massimiliano Salerno +39-06-91093-413 +39-06-91093-654 m.salerno@irbm.it www.irbm.it 180 2009 Preclinical R&D (chemistry, biology, bioanalysis) Drug discovery and development and services

Biological Patents · >5 External · Pharma, biotech, research institutes Collaborations Request for · Pharma, biotech, academia, Further Collaborations non-profit foundations

The privately owned IRBM Group today represents a diversified preclinical drug discovery group that provides integrated solutions from screening to preclinical candidate selection within the biotech and pharmaceutical sector.

IRBM, the parent company, was created in 2009 as a spin-off of the Italian Merck Research laboratories. The team delivered 25 preclinical candidates over nine years, including small molecules, peptides and synthetic vaccines, currently in clinical development. One of these molecules is Isentress, a First-in-Class HIV integrase inhibitor, winner of the Prix Galien USA 2008 as “Best Pharmaceutical Agent”. Other success stories are Grazoprevir, HCV protease inhibitor FDA-approved for the treatment of chronic hepatitis C, and Niraparid, PARP inhibitor in clinical development as an antitumor agent.

The company is committed to accelerating the discovery and preclinical development of disease modifying small molecules and peptidic drug candidates. Therapeutic areas of expertise include, amongst others, neurodegenerative, oncology and viral diseases.

Small molecule drug discovery Hit ID ·· Automated state-of-the-art sample repository ·· >100,000 compound collection including fragment library ·· Virtual screening (structure and ligand based approaches) ·· HTS screening platform (384, 1536 format) with multiple detection technologies ·· NMR-driven fragment-based approaches ·· Dotmatics data management Lead ID ·· Targeted libraries/exploratory SAR ·· Computer-aided drug design ·· Multi-objective optimisation ·· Complex synthesis including multi-chiral compounds ·· SFC analytical and preparative chiral separation ·· In vitro pharmacology

Member of

European Biotechnology NET WORK

Candidate ID ·· PK in all preclinical species ·· Drug-drug interaction and Met ID

IRBM

·· ·· ·· ·· ··

Cell permeability and transport Plasma protein binding, blood/plasma partition Oral absorption and first pass extraction Clearance and absorption mechanisms 2500 m2 Laboratory Animal Resources

Peptide therapeutics Phage Display (Peptide and antibodies) ·· Lead identification ·· Epitope discovery, Epitope mapping, Mapping protein-protein interactions ·· Selection and Screening random Peptide Libraries ·· Affnity selection & biopanning ·· Sequence analysis to confirm target binding and Synthesis of the isolated specific peptides Peptide Lead and Candidate ID ·· Targeted chemical libraries, virtual screening and structure-based driven combinatorial libraries ·· NMR studies of peptide sol. confs ·· Conformationally constrained libraries with proprietary uncoded AA ·· Libraries on protein domain ·· Chemoselective conjugations of peptides to proteins, small molecules, polymers, ligands ·· Multiparameter optimisation for activity, efficacy, selectivity ·· PK enhancing approaches & peptide conjugates IRBM is one shareholder of Advent, a joint-venture with Okairos Italia, a GMP facility producing novel investigational biologics, such as vaccines and gene therapy products, using adenoviral vectors.

IRBM Group inlcudes Promidis, a Milan-based medicinal chemistry-oriented SME with a strong track of record both as a high quality CRO and a developer of proprietary R&D. IRBM represents the Italian innovation hub and in 2010 created a public-private consortium, named CNCCS (Collezione Nazionale di Composti Chimici e Centro Screening), together with the Italian National Research Council (CNR) and the Istituto Superiore di Sanità (ISS) to expedite precompetitive innovative projects.

7 th european biotechnology guide 2017

94 | 95

Name · Innovation and Start-up Center for Biotechnology IZB Fördergesellschaft IZB mbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Am Klopferspitz 19 82152 Martinsried Germany Dr Peter Hanns Zobel +49-89-5527948-0 +49-89-5527948-29 info@izb-online.de www.izb-online.de 28 1995 S1 and S2 labs | Biotechnology | Life Sciences

Number of Firms · over 60 companies External · Collaborations with the scientific Collaborations institutes on the Campus Martinsried

Hotspots for life science start-ups The IZB, founded in 1995, is the operating company for the Innovation- and Start-up Centers for Biotechnology located in Planegg-Martinsried and Freising-Weihenstephan, and has developed into one of the top ten biotechnology centers in the world. Currently, in an area totaling 26,000 m 2, over 60 biotech companies with over 650 employees are located. An essential criterion for the success of the IZB is its close proximity to outstanding research at the Ludwig-Maximilians-University (LMU) and renowned biotechnology research establishments on the Campus Martinsried, such as the MaxPlanck-Institutes für Biochemistry and Neurobiology.

Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m2, has accommodated Start-ups focusing on medical biotechnology. Since 2002, the IZB in Freising-Weihenstephan with 3,000 m2 of space offers optimal conditions for establishing companies in the sector of life sciences.

Here, young entrepreneurs and company founders come upon an optimal infrastructure for transforming their products or services into business propositions, within a competence cluster for life sciences that is one of the best in the world. S1 and S2 labs for fair rental prices, internal property management, close contact to the venture capital scene, as well as joint location marketing are also factors for our success, as is the flexibility to adapt space requirements to the development of our tenants.

Top research at the Campus Martinsried Today the scientific and business Campus Martinsried is one of the largest centres in Europe where teaching, basic scientific and clinical research, as well as technology innovation are combined on one campus. Located in the direct vicinity are other institutes such as the MaxPlanck-Institutes for Biochemistry and Neurobiology, the HelmholtzZentrum Munich Hematology Unit and the following institutes of the LMU: the Biology Faculty, the Clinical Center Grosshadern, the Pharmacy and Chemistry Faculty, the Neurological Research Center, the Center for Neuropathology and Prion Research (ZNP),

IZB

the Gene Center and Institute for Biochemistry, the Biomedical Center, the BioSysM Bavarian Research Network for Molecular Biosystems and the Surgery Center of the Clinical Center Grosshadern.

The close proximity of the scientific institutes around the Campus Martinsried confers a huge competitive advantage. Young scientists can profit from incorporating expertise in science and research into their own business enterprises; short distances promote interaction and cooperation between biotech companies – in terms of globalisation both factors are essential requirements for successfully entering world markets.

IZB Residence and Faculty Club G2B The 28-meter high IZB Residence CAMPUS AT HOME that opened in October 2014 is the architectural and communicative centre point of the Campus Martinsried.

The sevenstorey building with 42 rooms and its own restaurant will accommodate visiting scientists from all over the world. The core element is the Faculty Club G2B. Its purpose is to promote the transfer of research results into marketable products and services, and intensify the dialogue between top class scientists.

IZB – in brief ·· 2 6,000 m2 laboratory and office space for start-ups and growing companies ·· Home for more than 60 start-ups ·· Business development support ·· In-house estate management ·· Center of an impressive research campus ·· Access to an international network ·· Flexible lab and office structures ·· Close contacts with investment partners ·· Joint location marketing ·· Attractive, modern conference rooms, also for external booking ·· Competitive leasing rents ·· IZB Residence CAMPUS AT HOME (42 Rooms) ·· Faculty Club G2B ·· Restaurants: SEVEN AND MORE and Café Freshmaker ·· 2 day care centres (BioKids & BioKids2) 7 th european biotechnology guide 2017

96 | 97

Name · JPT Peptide Technologies

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Volmerstrasse 5 12489 Berlin Germany Holger Wenschuh (CEO) +49-30-6392-5500 +49-30-6392-5501 info@jpt.com www.jpt.com

F  LI Q

60 2004 Biochemistry, Organic Chemistry, Medicinal Chemistry, Biology, Immunology Areas of Activity · Peptide-based products, services and research collaborations for immunotherapy, immune monitoring, biomarker discovery, proteomics and drug discovery Biological Patents · PepStarTM – Custom peptide microarrays PepSpotTM – High-throughput peptide synthesis PepMixTM –

Antigen-spanning peptide pools SpikeTidesTM – Peptide standards for proteomics SpikeMixTM – Stable isotope-labeled peptide pools PepTrackTM – Flexible custom peptide libraries External · Neo-Epitope Qualification (BioNTech Collaborations AG, Germany); Proteomics Kits (TU Munich, Germany; MSKCC, USA); Chronic Fatigue Syndrome Biomarkers (Charité, Germany) Request for · Immunotherapy development, cellular Further Collaborations and humoral immune monitoring, seromarker discovery, neo-epitope prioritisation, peptide lead discovery and optimisation, immune diagnostics, biomarker quantification

JPT Peptide Technologies is an ISO 9001 certified and GCLP compliant service provider and R&D partner for peptide-related projects in immunotherapy development, proteomics and drug discovery. Together with our US subsidiary, we serve a worldwide customer base in the pharmaceutical and biotechnology industries as well as at universities, governmental and non-profit organisations.

Innovations for immunotherapy & proteomics JPT’s proprietary technologies and corresponding product portfolio have helped to advance research efforts in the development of new immunotherapies against infectious and autoimmune diseases, allergies and cancer. JPT’s high quality peptide arrays, peptide pools and GxP peptides enable the development of novel immunotherapeutic applications as well as sophisticated immune monitoring. For the first time, broad and epitope resolved analysis and correlation of the cellular and humoral immune responses of diverse patient populations is feasible. This provides a basis for neo-epitope qualification, monitoring of epitope spreading, patient stratification and development of novel immune diagnostics and therapeutic approaches. In addition, our SpikeMixTM platform permits multiplexed and differential quantification of protein targets from biological samples.

JPT’s core technologies PepSpot™ – ultra-high-throughput peptide synthesis PepStar™ – patented peptide microarray technology PepMix™ – peptide pools spanning entire antigens PepTrack™ – flexible peptide libraries for T cell assays GxP Peptides – high quality peptides for immunotherapy SpikeTidesTM – peptide standards for proteomics SpikeMixTM – stable isotope labeled peptide pools

JPT

Products, services & collaborations Services: ·· Fast & low cost peptide libraries for neo-epitope qualification ·· Custom antigen peptides & pools for clinical immune monitoring ·· Custom GxP synthesis of peptides and peptide pools ·· Serological profiling using biological and clinical samples ·· Customised peptide standards for proteomics ·· Profiling of enzymatic activities ·· Tailored proteome-spanning peptide libraries and microarrays Catalogue products: ·· PepMix™ peptide pools from hundreds of antigens ·· RepliTope™ peptide microarrays for pathogens and tumour associated antigens ·· Enzyme substrate sets and microarrays for kinases, proteases, acetyltransferases, phosphatases etc. ·· Histone code peptide sets and microarrays ·· SpikeTidesTM Sets & SpikeMixTM for biomarker quantification using mass spectrometry Collaborations: ·· Neo-epitope-based immunotherapies ·· Neo-epitope qualification ·· Peptide lead identification and optimisation ·· Seromarker and epitope discovery and validation ·· Development of affinity ligands for therapeutic protein purification ·· Enzyme substrate discovery and qualification ·· Development of peptide kits for multiplexed biomarker quantification

Strategic outlook JPT is a key player in the constantly evolving and dynamic world of immunotherapy, immune profiling and proteomics. In addition to high quality GxP peptides for clinical applications, our comprehensive peptide toolbox for neo-epitope qualification, epitope discovery and immune monitoring adds value to the most essential development phases of novel immune therapeutics and diagnostics.

7 th european biotechnology guide 2017

98 | 99

Name · The Knowledge Transfer Network Ltd

Address/P.O. Box · Offices in London, Harwell, Edinburgh, Horsham Registered Office: Unit 218, Business Design Centre, Postal Code/City · Islington, London N1 0QH Country · United Kingdom Contact Person · Dr Terry O’Neill, Head of Health Email · enquiries@ktn-uk.org Website · www.ktn-uk.org Social Media · L Number of Employees · 150 Founded (year) · 2014 Areas of Activity · Knowledge Transfer for all sectors

The Knowledge Transfer Network (Health Community) The Knowledge Transfer Network (KTN) helps businesses get the best out of creativity, ideas and the latest discoveries, to strengthen the UK economy and improve people’s lives.

KTN links new ideas and opportunities with expertise, markets and finance through our network of businesses, universities, funders and investors.

From health to autonomous systems and from materials to design, KTN combines in-depth knowledge in all sectors with the ability to cross boundaries.

KTN is a network partner for Innovate UK, connecting with us can lead you to ·· potential partners, ·· horizon-expanding events, ·· bespoke support and ·· innovation insights relevant to your needs.

The KTN Health Team provides a single port of call for companies who contribute to life sciences and who require access to university research, investors, clinical expertise and research and technology organisations.

We do this by providing networking opportunities and events and access to specialist groups in strategic clinical or technology areas that enables companies to interact with ready-made, dynamic communities, in our key priority areas: ·· Regenerative medicine ·· Emerging medical technologies ·· Stratified/Precision medicines ·· Anti-microbial resistance ·· Independent living ·· Medicines manufacture ·· Digital health ·· Biosciences (Incl. Agri food, industrial biotechnology)

Member of

European Biotechnology NET WORK

K TN

Opening doors to UK and global networks The KTN Health Team open doors to wider networks.

We provide technology and market knowledge in a global context.

To understand more about the KTNâ&#x20AC;&#x2122;s role in H2020 visit: www.h2020.org/what-is-the-ktn

7 th european biotechnology guide 2017

100 | 101

Name · LEITAT Technological Center

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

C/ de la Innovació, 2. Terrassa 08225 Barcelona Spain Izabel Alfany, PhD +34-93-78823-00 +34-93-78919-06 international@leitat.org www.leitat.org

F IV

250 1906 microbiological, molecular biology and biochemical Areas of Activity · Oncology, Health and Wellbeing, Nutrition, Cosmetics, Skin biology, Toxicology (nano), Toxicological risk assessment, biocatalisis, bioprocess, biofilm, waste valorisation, environmental bioremediation Annual Turnover · h17 million

Biological Patents · WO2011157724A1; WO2014167030; WO2012098124A1 External · University College London, Karolinska Collaborations Institute, Allmirall, B Braun, CEA Leti, Newcastle University, Fraunhofer, Philips, Oryzon, BASF, Nestle, VTT. Request for · LEITAT acts as Technological Partner Further Collaborations by signing collaboration agreements to join efforts to meet the industrial technology challenges set out and promoting enterprising capacity and technology transfer. Moreover, LEITAT has wide experience with EU-Projects and look forward to build up new collaborations for H2020 framework projects.

Member of

European Biotechnology NET WORK

LEITAT is a Technological Center specialised in production technologies. LEITAT develops R&D activities in the areas of biomedicine, biotechnologies, environment, surface treatments, materials sciences and renewable energies with deep knowledge and experience in technological transfers to several industrial sectors. LEITAT takes part each year in many projects financed by the regional and national governments, participates in projects co-funded by the European Commission, and develops private R&D projects funded by industrial partners. LEITAT is recognised by the Spanish Government as a CIT (Centre of Technological Innovation) and is one the five Technology Centers that is accredited by the Regional Government of Catalonia. It is member of FEDIT (Federation of Technological Centers in Spain) and the IT (Technology Innovation) Network of the Catalan Regional Government.

LEITAT has six Knowledge Divisions, three of them are are specialised in Biotechnology sector: The Biomed Division of LEITAT’s R&D Department has its origins in the Bioinvestigation laboratory that Merck had in Barcelona, now Merck-Serono. The previous experience of the group accounts with more than fifteen years of preclinical investigation in oncology in a multinational pharmaceutical concern.

The currently Biomed’s objectives are: analysis of the therapeutic efficacy of new drugs; cancer therapy – new therapeutic targets, generation of drugs and its characterisation; diagnosis of diseases, infections, allergies, food: biomarkers, reagents, tools, and devices (LFD, biosensors).

Moreover, this Division counts with the following Technological Platforms: ·· Monoclonal antibodies (Mab): basic research, diagnosis and therapy. Recombinant proteins, polyclonals, production & purification (3 g), F(ab’)2, Fab, scFv. ·· Genetic engineering of Mabs: chimerisation, humanisation, fusion proteins, biosimilars, nanobodies. ·· Biogenomics, siRNA, DNA hairpins. ·· In vitro cell models: efficacy, MoA, cancer stem cells in oncology and inflammation. ·· In vivo animal models: efficacy, biodistribution, noninvasive imaging, pre-tox, pre-pk in oncology.

Leitat

The Safety & Sustainability Division of LEITAT has a broad expertise in the development of in vitro assays for efficacy, biokinetics and toxicity evaluation of substances. Such assays can be complemented by shortterm in vivo toxicity and biokinetic studies by different routes of administration. In addition, the division recently initiated its activities in the field of environmental toxicology, with new facilities and incorporating experts in soil and aquatic toxicity.

During the last years, a part of this group has devoted its activities on nanotoxicology. A broad range of in vitro tests of relevance for nanomaterial hazard assessment can be provided, including cell viability, inflammation, phagocytic activity, genotoxicity, membrane permeability, and stability in different biological fluids, as well as in vivo biokinetic and repeated dose toxicity studies. The team benefit from the highly interdisciplinary nature of LEITAT and the common infrastructure on nanomaterial research, which allows the thorough physicochemical characterisation of nanomaterials used along toxicological tests.

The Environmental & Bio Technologies Division of LEITAT has a broad expertise in the development of biofilm models onto biotic and abiotic surfaces. In addition, this group has wide expertise in identifying alternative antimicrobials for different industrial applications.

Besides, the group is also focused on the application of Industrial Biotechnology for obtaining more efficient processes and innovative products from commercial or renewable substrates (derived from biomass, waste, etc.).

Biocatalysis for the development of more sustainable processes as an alternative to chemical synthesis.

Moreover, the group has broad expertise in the application of enzymes as active ingredients in innovative fast moving consumer goods.

The group is also focused on the sequential combination of biotechnolgical and physico-chemical technologies allowing the maximum processes yields and obtaining new products on a comprehensive strategy applicable to biomass, municipal, industrial, or mixed waste.

Finally, the group has expertise in soil and water bioremediation in both industrial and natural environments.

7 th european biotechnology guide 2017

102 | 103

Name · Lonza Cologne GmbH

Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · ·

Nattermannallee 1 50829 Cologne Germany Dr Karl Clasen Dr Claus-Dietmar Pein +49-221-99199-0 +49-221-99199-111 Info.cologne@lonza.com www.lonza.com

FL I  105 1998 S1 | BioAssay products and services | Electrophoresis and analysis | Mycoplasma detection and prevention | Pluripotent stem cells | Primary cells and media | Transfection | QC testing solutions

Company profile Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech, and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitisers, from vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria, and other pathogens.

Founded in 1897 in the Swiss Alps, Lonza today is a global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 employees worldwide. The company is organised into two marketfocused segments: Pharma&Biotech and Specialty Ingredients.

Integrated solutions Lonza Pharma&Biotech provides the biotech market with the tools life science researchers use to develop and test therapeutics, from basic research to final product release. Lonza’s bioscience products and services range from cell culture and discovery technologies for research, to quality control tests and software to ensure product quality. Lonza Bioscience Solutions serves research customers worldwide in pharmaceutical, biopharmaceutical, biotechnology, and personal care companies, as well as academic and government research institutions.

Research tools for biologically relevant results At the BioCampus Cologne, Lonza Bioscience Solutions develops and commercialises non-viral gene transfer products for primary cells and hard-to-transfect cell lines. Primary cells more accurately reflect the condition and behaviour of cells within an organism when com-

Lonza cologne

pared to commonly used laboratory cell lines. Therefore, they are important model systems for both basic and clinical research.

One of Lonza’s latest innovations, the RAFT™ 3D Cell Culture System, offers simple protocols that allows setup of 3D cell cultures within an hour. The versatility of the RAFT™ System is beneficial in certain applications such as development of corneal models or blood-brain barrier models, where a multi-layer co-culture set-up is difficult to achieve with conventional methods.

Human Bronchial Smooth Muscle Cells in RAFT™ 3D Cell Culture

The 4D Nucleofector™ Core Unit

With Lonza’s highly efficient Nucleofector™ Technology, the functionality of different genes can be analysed in biologically relevant cell types. These results help identify possible new pharmaceuticals and therapies, for example to fight cancer or cardiovascular diseases.

Building on that standard Lonza recently launched the 4D-Nucleofector™ LV-Unit, uniting small- and largescale transfection applications in one system. The new unit expands the proven system to closed, larger scale transfection without the need for re-optimisation.

Lonza’s cell production facility can produce billions of Cells on Demand™ including passaging, feeding, and cryopreservation. Quality-tested cells are delivered assay ready in the requested format. Furthermore our service can develop specific assays for produced cells. Thus laboratory managers can focus on their experiments instead of cell provision and assay development.

QC tests from people who use them Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin, mycoplasma, and microbial detection products, as well as paperless QC microbiology, software, and services that support the critical needs of regulated manufacturing environments in the Pharma&Biotech market.

Cells on Demand™ Transfection Services

7 th european biotechnology guide 2017

104 | 105

Name · M+W Central Europe GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Lotterbergstr. 30 70499 Stuttgart Germany Ilga Palfner +49-711-8804-1800 +49-711-8804-1888 contact.ce@mwgroup.net www.ce.mwgroup.net 850 1995 | Consulting | Engineering | Construction | Process systems | Qualification & Validation | Commissioning | Technical Facility Management

Company profile M+W Central Europe GmbH, a wholly owned subsidiary of the M+W Group, is one of the leading engineering and construction companies for the pharmaceutical, life sciences, chemical and other high-technology industries. Clients include both large and medium sized enterprises as well as start-up companies. The needs and requirements of our customers are our key priorities – we are the right partner for you when it comes to biotechnology.

Facilities & equipment M+W Central Europe has the experience and the knowhow for planning and execution of all types of biotechnology production systems, providing expertise for research plants and industrial facilities, mono-product or multi-product plants, variable single-use systems and large-volume stainless-steel production units.

M+W Central Europe customers gain individual or fullservice in complete process and facilities solutions from concept and design to construction of a new production facility.

Services & solutions The portfolio includes: ·· Consulting (EU-GMP, FDA, benchmarking, FDA audits) ·· Design (concept, basic, detail) ·· Process engineering ·· Customised process systems ·· Cleanroom technology ·· Modular delivery ·· Building services ·· Construction management ·· Realisation/Construction ·· Qualification/Validation ·· Technical facility management Whether you require a turnkey construction, design & build (EPC) or an EPCMV realization of a new production

SLF /HRQ 1DQRGUXJV

'HVLJQ DQG FRQVWUXFWLRQ RI SURGXFWLRQ IDFLOLWHV

SLF *(+&

:HOO LQWHJUDWHG SURFHVV HTXLSPHQW

0RGXODU GHVLJQ IRU ƃH[LEOH PDQXIDFWXULQJ

ZZZ FH PZJURXS QHW t %ULQJLQJ WKH IXWXUH RI WHFKQRORJ\ WR OLIH

SLF *OD[R6PLWK.OLQH

M+w Central europe

facility, laboratory and/or the conversion or extension of an existing facility, M+W Central Europe will find the best and most economical solutions to meet your deadlines.

Your requirements are our focus. Experienced project teams are your local professional partners delivering benefit on every continent.

GMP certified M+W Central Europe will realise your entire project under best quality demands – based on current EU GMP / FDA guidelines and other international standards. Following analysis of the requirements, these are subsequently implemented in a pragmatic manner with the aid of risk analyses. Solid basis of our work is an implemented quality management and EHS system.

References (Selection) Abbott · Astellas · Aenova · AVON · AYANDA · Baxter · Bayer · Beiersdorf · Biomm · Boehringer Ingelheim · B. Braun · Catalent · Chr. Hansen · CureVac · CSL Behring · Daiichi Sankyo · Danisco · Dr. Kade · DSM · Evonik · Ferring · Fresenius · Gambro · Gedeon Richter · GE Healthcare · GlaxoSmithKline · Hermes · Hexal · Innovacell · Intervet · Klosterfrau · Leon Nanodrugs · Merck · Merckle · Merz · Nestlé · Novartis · Oxea · Pfizer · Polpharma · Qiagen · Roche · Salutas · Sanofi · Sandoz · Sanfarm · Solvay · Steigerwald · Takeda · TEVA · Unilever · Vetter Pharma · WDT · Ypsomed

Locations Germany: Stuttgart (HQ), Berlin, Biberach, Dresden Ludwigshafen, Leverkusen, Marburg, Nuremberg, Penzberg, Schwarzheide, Schwedt Austria: Vienna Switzerland: Allschwil/Basel, Schlieren/Zurich Belgium: Melsele/Antwerp Poland: Gdansk, Wroclaw, Warsaw Russia: Moscow, St. Petersburg Serbia: Belgrade

7 th european biotechnology guide 2017

106 | 107

medicines for europe

better access. better health.

Name · Medicines for Europe

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)

· · · · · · · · · ·

50 Rue d’Arlon 1000 Brussels Belgium Trudy Beks +31-6-41190824 trudy@medicinesforeurope.com www.medicinesforeurope.com/event

LI 20 1993

In brief · Medicines for Europe began over 20 years ago as the European Generic Medicines Association (EGA) with the goal of representing the emerging generics industry, later growing to include biosimilar medicines in its portfolio. As the pharmaceutical industry and the healthcare environment within which it operates have evolved, so has our Association.

When the EGA was first launched back in 1993, generic alternatives to branded medicines made up a fraction of the market. As more of these medicines have come offpatent, and the benefits and value of generics to both patients and healthcare providers have become clearer, so has the provision of generic medicines increased dramatically.

Our members provide the essential medicines that European patients, healthcare professionals, and healthcare systems rely on to treat the most acute and chronic conditions and ailments, covering a wide range of diseases from cardiovascular to diabetes and cancer. Improved access to the most effective therapies means millions more patients are getting better and living longer, while healthcare inequalities are being reduced.

We now supply over 56% of all medicines in Europe, and over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas. For the treatment of high blood pressure alone, almost 50 million patients are taking generics each day, and 20 million people across Europe are now being treated for diabetes with generics.

Technological advances and innovations have had a massive impact on the pharmaceutical industry, including the development of new and highly innovative biological medicines – medicines whose active substance is produced by or extracted from a biological source. We have responded to this opportunity with biosimilar medicines – medicines that are highly similar to existing biological medicines, without any meaningful difference in terms of efficacy. With more than 10 years of positive patient and treatment experience in the market, the first biosimilar medicine was approved by the EU in 2006, and the use of biosimilar medicines is expected to result in savings of up to €33.4 billion for 8 EU countries by 2020.

More recently, we have expanded into value added medicines aimed at optimising, rethinking, and reinventing existing medicines based on known molecules, to address the unmet medical needs of patients through improved care delivery systems. Value added medicines

Medicines for Europe

deliver relevant additional improvements for patients, healthcare professionals, and/or payers. Benefits include an improved efficacy, safety, and tolerability profile, better adherence, better quality of life, better convenience of use, and/or patient preference.

Medicines for Europe also organises different conferences on recent developements and updates in the generic, biosimilar, and value added medicines sectors.

The following events will be taking place in 2017: The 13th Medicines for Europe Legal Affairs Conference from 22–23 March 2017 in London will be a forum of high-level discussions between leading industry executives and experts, counsel, and European institution officials on the latest IP legal landscape developments with regard to generic, biosimilar, and value added medicines in Europe and worldwide.

The 15th Biosimilar Medicines Conference has become, over the years, the annual gathering of international experts in the field of biosimilar medicines and a flagship event for an ever-growing number of stakeholders. The Biosimilar Medicines Group will organise its 2017 annual conference ‘Biosimilar Medicines: a game changer for healthcare sustainability’, in London on 23 & 24 March.

The Conference will provide insight into the current state of play in the EU and will stimulate debate, in a multistakeholder setting, on the important role of biosimilar medicines in the sustainability of healthcare systems. In addition to providing a comprehensive outlook of key European market access policies, a panel of renowned international regulators will outline the key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions.

The Joint 23rd Medicines for Europe and 20th IGBA Annual Conference held from 14–16 June in Lisbon will unite over 300 experts from the generic and biosimilar sector to provide market trends, innovative commercial strategies, new updates, and opportunities for growth for affordable medicines. At this unique event the participants will not only gain new information but will also have the opportunity to enjoy many enjoyable networking get-togethers in the beautiful surroundings of Portugal’s capital Lisbon!

7 th european biotechnology guide 2017

108 | 109

Name · Microsynth AG Subsidiaries: Microsynth Austria GmbH Microsynth Seqlab GmbH ecogenics GmbH Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Fax Email Website

· · · ·

Founded (year) · Type of Laboratory ·

Areas of Activity ·

Schützenstrasse 15 9436 Balgach Switzerland Dr Markus Schmid Christof Wunderlin +41-71-722 83 33 +41 71 722 87 58 info@microsynth.ch www.microsynth.ch www.microsynth.at www.ecogenics.ch www.microsynth.seqlab.de 1989 ISO 9001:2008, ISO 17025:2005 (refers to NGS, Sanger and genotyping labs) GMP certified Sanger sequencing lab 1. Synthesis of DNA/RNA oligonucleotides 2. DNA sequencing (Sanger, NGS), DNA/RNA isolation, qPCR and genotyping analyses 3. Contract research/outsourcing

Request for · Microsynth is looking for Further Collaborations collaborations in the field of molecular diagnostics where we will provide our DNA synthesis and analytics knowhow, while relying on the know-how of the partner(s) in medical and regulatory affairs.

The company is open to any new collaboration with pharma/biotech companies, public or academic institutions with the objective of getting involved in innovative or challenging scientific projects (e.g. EU projects).

Company mission It is Microsynth’s mission to be a leading service and solution provider for molecular biologists who require either high-quality DNA/RNA oligonucleotides, sophisticated DNA/RNA sequencing & analysis solutions, or want to outsource entire research projects.

History Microsynth was founded in 1989 by Dr Tobias Schmidheini and is currently active in three different business areas. When Dr Schmidheini started to produce DNA oligonucleotides on behalf of Swiss academic institutes and the pharma industry in 1989, he became one of the pioneers in this area. Meanwhile the company is offering its worldwide customers any kind of DNA/RNA oligonucleotides. By 1992, the company had entered the business field of DNA sequencing. Today, Microsynth is well-positioned also in this area, and is able to offer its customers both traditional Sanger sequencing services, as well as state-of-the art next generation sequencing (NGS) services. The third business area (contract research/outsourcing) is essentially a combination of DNA/ RNA synthesis with DNA sequencing alongside other expert areas such as DNA/RNA isolation, qPCR and genotyping. Customers can rely on application specialists with outstanding track records in academia as well as Microsynth’s expertise in high-throughput logistics.

Products & services 1. Synthesis of DNA/RNA Oligonucleotides ·· DNA and RNA oligonucleotides for various research purposes ·· siRNAs and antisense oligonucleotides for gene silencing (e.g. 2’ MOE gapmers) ·· DNA oligonucleotides for molecular diagnostic applications ·· Large-scale oligonucleotides up to kg quantities (e.g. for pilot scale production) ·· Primers for NGS applications (e.g. Illumina primers)

We Enrich Your Research …

Microsynth

The Best Thing That Can Happen to a DNA

Our Know-How For Your Success: Since 1989!

2. DNA/RNA Sequencing and Analysis ·· DNA Sanger sequencing services (single-tube & plate sequencing, primer walking) for various research purposes ·· GMP-compliant and GLP-like Sanger sequencing including documentation ·· Next generation sequencing, including bioinformatics and project consulting with focus on ·· Small genome and eukaryotic model organism sequencing ·· Transcriptome analysis (e.g. RNA-Seq) ·· Amplicon deep sequencing (e.g. CRISPR/Cas9) ·· Metagenomics sequencing ·· Real-Time PCR analysis, including assay development for ·· Food testing (species, allergens, GMOs etc.) ·· Veterinary-medical applications (e.g. eradication of BVD) ·· Gene expression analysis ·· Genotyping of plants and animals (e.g. GBS) ·· Paternity testing and cell line authentication testing ·· DNA/RNA (high-throughput) isolation from diverse biological sources 3. Contract Research/Outsourcing ·· Design and execution of all kinds of DNA/RNA related research projects (see our website for project examples and customer references)

Management and personnel Dr Tobias Schmidheini (Chairman of the Board) Dr Markus Schmid, Christof Wunderlin (Co-CEOs) Dr Christoph Grünig (Head Contract Research/Outsourcing) Microsynth employees a team of internationally trained scientists and technicians with strong backgrounds primarily in the area of molecular biology (almost half of Microsynth’s staff hold a PhD). We believe that our specific expertise, in combination with our mission, makes us a qualified and reliable partner for empowering molecular biology research.

7 th european biotechnology guide 2017

110 | 111

THE POWER OF IMMUNOTHER APIES

Name · MOLOGEN AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · ·

Fabeckstr. 30 14195 Berlin Germany Claudia Nickolaus +49-30-841788-0 +49-30-841788-50 info@mologen.com www.mologen.com ~60 1998 Clinical drug development in the areas of cancer and infectious diseases

Annual Turnover · +/- €0m Relevant R&D Budget · ~€17m Biological Patents · Comprehensive international patent protection for our product candidates External · l Freie Universität Berlin, Germany Collaborations l Aarhus University Hospital, Denmark l The University of Texas MD Anderson Cancer Center, USA Request for · Partnering opportunities for our comFurther Collaborations pounds

MOLOGEN AG – Technology leader in targeted immunotherapies With new and unique technologies and active substances, MOLOGEN is one of the pioneers in the field of immunotherapies. Our product development helps combat some of the most threatening diseases. Apart from the core focus on oncology, we also develop immunotherapies for the treatment of infectious diseases.

Our approach concentrates on drug candidates for which there is high medical need. As a bio-pharmaceutical company, MOLOGEN is oriented toward closer-tomarket proprietary product candidates which have advanced beyond the basic research stage. Our foremost objective is the successful out-licensing and marketing of our products, particularly our lead product lefitolimod (MGN1703).

All products are based on the same active principle: they activate the human immune system to combat the disease itself. It is a highly promising approach which we are driving forward with great confidence and from which patients who are reliant on innovative treatment options stand to benefit. Without exception, our products have demonstrated good efficacy and excellent tolerability, which is a particularly noteworthy characteristic for cancer therapies.

DNA-based TLR9 agonists The focus of our development work is on MOLOGEN’s proprietary platform technology: the product family of DNA-based TLR9 agonists. This includes our lead product, the immunotherapeutic lefitolimod, and its follow-up molecules EnanDIM®. Since the summer of 2014, lefitolimod has been subject to a Phase III pivotal study for colorectal cancer. The results of this are expected in 2019. This means that lefitolimod is one of the few product candidates in the field of immuno-oncology to be close to market. Furthermore, lefitolimod is also being tested in a Phase II trial in small cell lung cancer (SCLC). The results for this are expected by mid-2017.

In 2015, a Phase I/II study in a non-oncological indication was launched for the first time: with focus on HIVpositive patients. In addition, lefitolimod is being inves-

Mologen

tigated with the checkpoint inhibitor Yervoy ® (ipilimumab) in various cancer indications within the scope of a Phase I combination study.

Cell-based therapeutic vaccine Our product portfolio includes another proprietary cellbased therapeutic vaccine, MGN1601, to treat advanced renal cancer. The further development of MGN1601 has been shelved for the time being. It is anticipated that this will be re-initiated at a later date, for example following the successful out-licensing of lefitolimod.

Partnering We offer pre- and clinical drug candidates in the highly attractive field of immunotherapies. Due to their known or expected good safety profile they offer as well a tremendous potential for combination therapies to enhance the efficacy of other immunotherapies.

MOLOGEN is primarily seeking licensing partners for the TLR9 family with its compounds lefitolimod and EnanDIM® – with the option for flexible cooperation arrangements.

7 th european biotechnology guide 2017

112 | 113

Name · NBE-Therapeutics AG Technology Park Basel Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Hochbergerstr. 60C 4057 Basel Switzerland Dr Ulf Grawunder, CEO +41-61-633-2230 +41-61-633-2231 info@nbe-therapeutics.com www.nbe-therapeutics.com 14 2012 Cell & Molecular Biology Development of Antibody Drug Conjugates (ADCs)

Annual Turnover · h6.0 m Relevant R&D Budget · h5.0 m Biological Patents · WO2014013026 / EP2692865B1, WO2014140317, WO2016102679, WO2016128410 External · undisclosed Collaborations Request for · ADC co-development collaborations Further Collaborations

NBE-Therapeutics is a privately held Swiss Biotechnology start-up company that was incorporated in 2012 and is located in the Technology Park Basel, Switzerland. The company focuses on the development of next-generation antibody drug conjugates (ADCs) for improved treatment of cancer. Antibody drug conjugates combine the principle of specific targeting of cancer cells via antibodies with chemotherapy. To do this, ADCs contain highly potent small-molecular weight cytotoxic compounds of even higher potency than standard chemotherapeutic drugs, tightly coupled to an antibody specific for a given cancer type. This principle results in the targeted delivery of highly potent cellular toxins, specifically to cancer cells, with significantly fewer side-effects, because the ADC is designed to deliver its toxic payload to the cancer cell only once it has bound to its target.

The vision of NBE-Therapeutics – and of its founder, Dr Ulf Grawunder, and his team – is to develop a portfolio of ADC product candidates to clinical validation in cancer patients. In the four and a half years since incorporation, NBE-Therapeutics has raised about €25m in funds from investors, as well as various research grants for collaborations with top-tier academic institutions, such as The Scripps Research Institute (USA) ETH-Zürich, and the University of Basel. The investors consortium is led by the Boehringer Ingelheim Venture Fund (BIVF), in Germany, and PPF, in the Czech Republic, and also includes Swiss and German private investors.

Meanwhile, the company has grown to 14 employees and is managed by Dr Ulf Grawunder as CEO and Dr Roger Beerli as CSO. In order to develop best-in-class ADC product candidates, NBE-Therapeutics leverages three proprietary technology platforms, including an antibody discovery platform (Transpo-mAbTM display), a sitespecific conjugation technology (SMAC-technologyTM, SMAC= sortase mediated antibody conjugation), and an ultra-potent anthracycline-based toxin platform.

NBE-Therapeutics

In comparison to first-generation ADCs usually generated by chemical conjugation, the NBE-Therapeutics next-generation ADCs are highly homogeneous, stable, and exhibit superior efficacy in murine tumour models with human tumour cell lines (CDX-models) or tumor biopsy material (PDX models) in comparison to benchmark ADCs generated with conventional technologies.

In addition, the companyâ&#x20AC;&#x2122;s ADCs have been shown to trigger a strong immune-protection against the targeted tumour, preventing tumor relapse in immunocompetent tumour models, lending hope that this durable antitumour effect can be achieved in cancer patients and in future clinical trials as well.

NBE-Therapeutics is currently active in developing nextgeneration ADCs against four different cancer targets, that address cancers of high unmet medical need: cancers of the lung, colon, breast, and pancreas. These activities are supported by collaborations with top-tier academic partners, and first commercial collaborations utilising the companyâ&#x20AC;&#x2122;s ADC development capabilities have been initiated as well. NBE-Therapeutics has developed highly potent ADC lead candidates for two of its four ADC target programmes and plans to enter a first ADC product candidate into IND-enabling preclinical development and cGMP production in 2017. Based on these developments, it is planned to commence clinical trials in cancer patients with one or two of the ADC lead candidates in 2019.

7 th european biotechnology guide 2017

114 | 115

Name · Novaliq GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Im Neuenheimer Feld 515 69120 Heidelberg Germany Dr Christian Roesky +49-6221-502590 +49-6221-5025921 info@novaliq.com www.novaliq.com 60 2004 Chemical, pharmaceutical Ocular drug delivery, ophthalmology pharma

Biological Patents · 23 patent families in the area of topical drug formulations External · Universities of Cologne, Collaborations Mannheim, Vienna, Munich, Queens University Belfast, University of Auckland Request for · Novaliq offers its own OTC and clinical Further Collaborations development products for licensing to suitable marketing and distribution partners worldwide that are capable of performing registration studies in their territory. Novaliq also welcomes invitations from interested parties to enter into discussions about partnership development opportunities.

The organisation Novaliq GmbH, based in Heidelberg, is a drug delivery company developing a superior generation of innovative ocular formulations for poorly soluble drugs using its unique drug carrier platform and proprietary EyeSol® technology. The patented ocular formulations are based on semi-fluorinated alkanes (SFAs), highly biocompatible and non-aqueous liquids, which can be easily applied in the form of topical eye drops. A new generation of both prescription and consumer ocular products is possible through the unique and proprietary properties of SFAs as the delivery vehicle. Since its establishment, Novaliq has obtained 53 million euros from its major shareholder, dievini Hopp Biotech Holding, the investment vehicle of SAP founder Dietmar Hopp.

Business strategy Novaliq’s strategy is to establish an innovative portfolio of consumer and prescription drug products for the major ophthalmic indications Dry Eye Disease, Glaucoma, and Retinal Diseases.

Technology Novaliq has developed a new and proprietary technology called EyeSol®, a non-aqueous, and preservativefree drug delivery system. The physicochemical properties of the technology enhance the solubility, suspensibility, and stability of poorly formulatable drugs. The EyeSol technology has an established ocular safety profile from two decades of use in the anterior and posterior segment.

Product pipeline Novaliq GmbH currently has several product candidates with excellent market potential in various stages of development. Novaliq’s most advanced product candidates are described below.

Novaliq

NovaTears®/EvoTears™ Lubricant eye drops for dry and irritated eyes NovaTears®, based on Novaliq’s EyeSol technology, is the company’s first ophthalmic product which received the CE mark. NovaTears has superior wettability compared to all other available eye drop technologies due to its significantly reduced surface and interface tension.

NovaTears OTC is a multi-dose, non-aqueous, nonblurring and preservative-free topical eye drop for lubrication of the ocular surface.

Several observational studies with NovaTears OTC eye drops have been successfully completed, showing excellent clinical performance and safety in patients with hyper-evaporative dry-eye disease and meibomian gland dysfunction. The product has been partnered with Ursapharm and has been commercially available under the brand name EvoTears ® in Europe since October 2015. Novaliq is in the process of partnering the product to other geographic regions.

CyclASol® An SFA-based Cyclosporine A solution to treat Dry-Eye Disease (DED) Novaliq has employed its SFA-based proprietary EyeSol ophthalmic drug delivery technology to develop CyclASol® – a novel, proprietary, non-aqueous solution of cyclosporine A to treat moderate to severe DED. As a completely nonaqueous system, it is provided preservative-free even in multi-dose units. A clinical phase 1 study for CyclASol (CYS-001) was successfully conducted. In a phase 2 US study with 200 patients CyclASol showed significant improvement in a sign, earlier onset of action than an active comparator drug and an excellent safety profile. Pivotal clinical studies are planned for 2017.

Management Dr Christian Roesky, CEO Dr Oliver Schlüter, CFO Bernhard Günther, Co-Founder & CIO Dr Hartmut Voss, CBO Dr Frank Löscher, CTO 7 th european biotechnology guide 2017

116 | 117

Name · NSF International

Address/P.O. Box · The Georgian House, 22/24 West End, Kirkbymoorside Postal Code/City · YO62 6AF, York Country · United Kingdom Contact Person · John Johnson Telephone · +44-1751-432-999 Email · johnjohnson@nsf.org Website · www.nsfpharmabiotech.org Social Media · I Number of Employees · <50 Founded (year) · 1944 Areas of Activity · l Auditing l Consulting l Training l Testing

The company NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, training and clinical testing on a global basis.

Recent public health concerns and challenges have underscored regulators’ proactive pursuit of compliance in the pharmaceutical industry. The market’s need for outsourced, independent, third-party pharmaceutical and biotech support services has been recognised by industry experts. NSF offers solutions tailored to your industry requirements and company-specific objectives. Our staff of former EU and FDA officials, in addition to our industry experts, enables us to combine global regulatory knowledge with industry best practices to help our clients achieve what they need to, all whilst remaining updated during increasingly turbulent times of change.

Our not-for-profit status means we act in your long-term best interest based on good science, expert experience, and common sense. We care about you, our clients, which is why over 87% come back for more.

Our specific services Providing you with solutions across the product lifecycle. ·· Customised education programmes that will change behaviours, improve performance and ‘future proof’ your organisation. You are only as good as your people! ·· Qualified Person education. More people have become “QPs” in Europe through our training programme than any other training provider. ·· Remediation consultancy. Helping you successfully manage warning letters, consent decrees, import alert notifications, WHO delisting and removal of manufacturing and marketing licenses in the EU. With us you will become better prepared and emerge as a stronger company. ·· Quality System simplification, implementation, compliance assessment and benchmarking against best industry practice. We want you to have a Quality System that will provide you with commercial advantage. One that is simple and effective. ·· Regulatory inspection readiness and mock inspections. We will help you to succeed in your next FDA, EU, or WHO inspection.

NSF International

·· Data integrity assessments. Let us help you find and close the gap before it’s too late. ·· Helping you to error-proof your processes and systems and drive continuous improvement. ·· Leadership development and coaching. ·· Auditing of third parties and suppliers. Let us help you to sleep easy at night! ·· Due diligence audits. We will help you spend your money wisely. ·· Auditor certification. We will independently “certify” your GMP auditors so you can be confident of their findings. ·· GMP remediation. Programmes that provide a sustainable, proportionate, and comprehensive roadmap to survive and then thrive in the field of bio and biosimilar manufacturing. ·· Corporate due diligence, risk assessment and specialist consultancy when acquiring or merging with bio production facilities outside your organisation.

Why choose NSF’s pharma biotech services?

MEET OUR TEAM

Peter Gough Executive Director

Martin Lush Global Vice President

John Johnson Executive Director

Mike Halliday UK Vice President

Rachel Carmichael Executive Director

Our clients tell us we’re different, which is why they stay with us. ·· Our people are the best; experienced and pragmatic.

They have been in your shoes. They understand your world and they care, a lot. ·· We treat you as partners, not clients. We work with you and stick with you, no matter what. ·· We want to make your life easier and your business better. We will tell you what you must STOP doing in order to succeed. ·· We believe in preparing you for the future, not for a world that no longer exists. ·· We will help you simplify, not complicate. ·· With offices in five continents we understand the different languages and cultures better than most.

We will help you enhance and embed the right culture throughout your organisation.

The right people. The right solution. The first time.

For more information about NSF’s pharma biotech services, visit www.nsfpharmabiotech.org, email pharmamail@nsf.org or call +44 1751 432 999.

7 th european biotechnology guide 2017

118 | 119

Name · OPIS srl

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Palazzo Aliprandi – Via Matteotti, 10 20832 Desio Italy Raphaela Schnurbus +39-0362-633-381 +39-0362-633-633 raphaela.schnurbus@opis.it www.opis.it

I > 250 1998 Premium support for Clinical Drug Development

Annual Turnover · > 26 million External · | Pharma Collaborations | Biotech | Medical device companies | Nutraceutics

The company OPIS is an international CRO (Contract Research Organization) providing clinical research services to Pharmaceutical, Biotechnological and Medical Device industries.

With nine subsidiaries across Europe, OPIS is a trusted, cost-competitive solution for managing all aspects of clinical trials. Our services include assistance and scientific advice in the developmental phase, front-end services such as monitoring and study management and centralised services including Data Management, Statistics, Pharmacovigilance and other e-Clinical services (phases I–IV).

With significant experience in the major therapeutic areas and more than 1,100 trials completed, we guarantee quality, ISO 9001 and ISO 27001 compliant services in line with Good Clinical Practice (ICH-GCP) guidelines and standard operating procedures (SOP).

Our priority is to protect the rights, the safety and the welfare of the patients as well as ensuring the integrity, transparency and reliability of the data collected.

The OPIS Clinical.NET study portal has been validated in accordance with FDA 21CFR part 11 regulatory requirements.

Study types ·· ·· ·· ·· ·· ··

Proof of Concept Phase I–IV studies Observational studies Investigator Initiated Trials Medical device studies OTC, Consumer Healthcare

OPIS

Services ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··

Medical writing Site selection Trial start-up Monitoring Study management Quality management Pharmacovigilance Document management e-Clinical services Data management Statistics Scientific advice Training

Company strength

Your partner for digitalized trials

Full geographic coverage ·· Nine subsidiaries ·· Local and international studies Study management and local regulatory/start-up experts ·· Assistance in appropriate site selection ·· Validated resources to conduct early phase studies Biometry centre of excellence ·· Scientific advice and statistical consultancy ·· Highly qualified and experienced staff e-Clinical solutions ·· In-house developed, web-based solutions ·· Specialised clinical IT team

www.opis.it

7 th european biotechnology guide 2017

120 | 121

Name · PharmaCell B.V.

Address/P.O. Box Postal Code/City Country Contact Person

· · · ·

Telephone Email Address Internet Website Number of Employees Founded (year) Areas of Activity

· · · · · ·

Oxfordlaan 70 6229 EV Maastricht The Netherlands Alexander Vos (CEO) Dr Soenke Brunswieck, (Director Business Development and Project Management) +31-43-35-09910 info@pharmacell.nl www.pharmacell.nl 70 2005 l Contract manufacturing for cell & gene therapies l Clinical trial manufacturing from Phase I to Phase III l Commercial manufacturing of advanced medicinal products (ATMPs) l Process development, up-scaling and automation l QC testing l Fill and finish l Storage and distribution of clinical trial material l GMP consultancy

External · l Founding Member of Alliance for Collaborations Advanced Therapies (AAT) l Alliance for Regenerative Medicine (ARM) l International Society of Cellular Therapies (ISCT) l Collaborations with American and European Life l Science companies and academic institutes in several FP7/Horizon 2020 projects and other activities l Collaborations with Brightland Chemelot Campus B.V. in cooperation with Maastricht Health Campus

PharmaCell – a leading CMO for cellular & gene therapies in Europe Since the foundation of PharmaCell B.V. in 2005, the company has become one of the leading Contract Manufacturing Organisations (CMO) focused on cell & gene therapies. As a Centre of Excellence, PharmaCell is helping to unlock the potential of cellular therapies for the benefit of patients. PharmaCell aims to be the leading European CMO and cell therapy provider of human therapeutic cell therapy products to the global life science industry.

PharmaCell focuses solely on cell & gene therapy manufacturing and brings experience with autologous and allogeneic manufacturing for clinical programmes for clients to provide solutions in the design of clinical programmes.

With a proven track record, PharmaCell works with European and US-based biotechnology companies on preclinical preclinical development to commercial projects projects. PharmaCell covers the full range of manufacturing services. Starting from GMP consultancy, process development, fill and finish, QC testing, storage and distribution of clinical trial materials, and clinical trial manufacturing from Phase I to Phase III, we are also equipped to support and manufacture commercial cell therapy products for the European market & beyond.

In order to help to unlock the potential of cell therapies for the benefit of patients, PharmaCell’s CMO services range from thorough transfer of technologies, QP release of products and controlled temperature transportation to process development, including cell culture scale-up know-how and manufacturing of ATMPs (advanced therapy medicinal products).

PharmaCell aims to provide flexibility to clients, by ·· Designing a Technology Transfer project to the requirements of the clients ·· Structuring a manufacturing capacity programme in line with patient recruitment ·· Having project teams and cleanroom available 24/7

pharmacell

PharmaCell is located in the centre of Europe at approximately one hour driving distance from Brussels, Antwerp, Cologne, and Dusseldorf. PharmaCell operates two state-of-the-art cGMP-licensed facilities for human cell & tissue culturing in Maastricht and Geleen (The Netherlands). PharmaCell’s two GMP cell manufacturing facilities combine more than 6,500m² (70,000 sqft), offering the full range of flexibility and scalability.

PharmaCell’s international team consists of experts related to all quality aspects, manufacturing, engineering, process development, and project management.

Each department has a representative in a dedicated core team that is committed to manufacturing your product and becomes involved from the Technology Transfer onwards.

Due to our broad expertise and longstanding know-how and our two cell manufacturing centres of excellence, PharmaCell is the CMO of choice for pharmaceutical and biotech companies, as well as academic institutions in this field.

Our Maastricht Cell Manufacturing Facility was first GMP-certified in 2006 and has been successfully inspected by the Dutch authorities (IGZ) on a regular basis thereafter. The Geleen Cell Manufacturing Facility was first GMP-certified by the Dutch authorities (IGZ), on a regular basis thereafter. In 2016 PharmaCell received a licence for manufacturing gene therapy products.

PharmaCell aims to help accelerate technology development in the industry, mostly focused on upscaling and automation. PharmaCell is involved in projects with international consortia from both academia and industry to bridge the path from preclinical development to clinical manufacturing.

7 th european biotechnology guide 2017

122 | 123

Name · Polpharma Biologics

Address/P.O. Box · Gdansk Science and Technology Park Trzy Lipy 3 bld A Postal Code/City · 80-172 Gdan´ sk Country · Poland Contact Person · Federico Pollano Director Licensing and Contract Manufacturing Telephone · +48-885-501-041 Email Address · onestopshop@polpharma.com Internet Website · www.polpharmabiologics.com Social Media · I Number of Employees · 120 Founded (year) · 2013 Type of Laboratory · State of the art biopharmaceutical development centre for process development and optimisation, clinical trials, material production, and commercial supply of drugs substance, and drug products Areas of Activity · Contract development and manufacturing of biopharmaceuticals in cell culture including Fill&Finish External · Bioceros (cell line development), Collaborations BSP (antibody drug conjugates), BioEq (Biosimilars), universities, and research institutes Request for · All kinds of cooperation as a Further Collaborations one-stop-shop biopharmaceutical service provider covering all steps needed for development and production; co-developments and in-licensing of potential targets for further development

From idea to global market Polpharma Biologics is a division of Polpharma Group – one of the largest pharmaceutical companies in Central and Eastern Europe. We offer customised solutions for all stages of development and production to serve today’s and tomorrow’s global market needs. Our worldclass team of scientists and engineers provide not only invaluable experience and expertise but offer excellent advice that enables you to bring your product to the market even faster.

Know-how you can rely on With state-of-the-art facilities in Gdansk and Utrecht, we are at the forefront of the tech revolution in biotechnology, leveraging our knowledge and making the most of the innovative solutions available in our industry.

Following the acquisition of Bioceros, the Dutch biotech development unit, we have fully integrated our biotechnological development capabilities, allowing us to proceed with the development of biosimilar drugs.

To serve the growing global demand for biopharmaceuticals, we are also in the process of building a commercial-scale GMP production facility for API and aseptic Fill & Finish manufacturing in Duchnice near Warsaw, which will become operational in 2019. Total capacity of the plant will reach up to 12x 2,000 l cell culture production and aseptic F&F of 30m vials and carpules.

Polpharma

ONE-STOP SHOP

COMMERCIAL GMP MANUFACTURING

(�� �� 12�2000�)

Complex solutions tailored to your needs With unrivalled expertise, we are uniquely positioned to offer support and consultancy work at all stages of biopharmaceutical development, ranging from fee-forservice advisory to complex partnerships and long-term projects with shared responsibility for development.

We can support all stages of your biopharmaceutical development process, securing on-time commercial launch and subsequent supply at economically attractive conditions by leveraging our cost-effective footprint – or provide only selected services, working closely with your other contractors.

We offer tailor-made CDMO services in both biosimilars and innovative molecules as well as rapidly-developing new biopharmaceutical processes such as antibodydrug conjugates.

Our parent company – Polpharma – is Poland’s leading pharmaceutical company, with a strong established presence in the region of Central and Eastern Europe as well as in the ex-Soviet Commonwealth of Independent States. This allows us to draw on over 80 years of experience in these markets to support not only the production phase of new drug development but also commercialisation and future sales in the region.

The recent investments of Polpharma Biologics speak for themselves – we make things happen. Our biopharmaceutical one-stop-shop is waiting for you.

7 th european biotechnology guide 2017

124 | 125

Name · ProBioGen AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · ·

Goethestr. 54 13086 Berlin Germany Dr Wieland Wolf (CEO) +49-30-924-006-0 +49-30-924-006-19 info@probiogen.de cmo@probiogen.de · www.probiogen.de · FIQ · 107 · 1994 · S1, S2 · | Biopharmaceutical development and GMP Production Facility | Biopharmaceutical contract development and manufacturing | Technologies for improving product characteristics and process efficiency

Biological Patents · ProBioGen holds numerous international patents on technologies to improve product quality/potency and enhance cellular productivity.

External · With many international companies Collaborations and research organisations, e.g. LTC, Boehringer-Ingelheim, Max-PlanckInstitutes, etc.

Request for · ProBioGen works with biotech and Further Collaborations pharma companies developing complex therapeutic glycoproteins or viral vaccines. Services include cell line and process development, up to GMP-manufacturing, based on animal or human cell lines. In addition, proprietary product/process-improving technologies are out-licensed.

Intelligent biopharmaceutical solutions Internationally renowned specialist for developing and manufacturing complex therapeutic glyco-proteins; state-of-the-art service packages plus innovative platform technologies. Manufacturing authorisation for human biopharmaceuticals and operating to quality standards of the EMA and FDA.

Experience & client feedback Over 20 years a successful development partner for leading biotechs & pharmas on novel products, biosimilars, and biobetters, e.g. Fc-fusion proteins, clotting factors, enzymes, or others. Clients value our scientific expertise, excellent working relationships, and outstanding flexibility.

Services Quality development services Offer as true “one-stop-shop” complete service packages from early lead optimisation, rapid and integrated development of high-producer cell lines, processes and analytical methods, up to full GMP manufacturing programmes.

Comprehensive analytics portfolio, incl. standard inprocess & release tests, and in vitro bioactivity assays.

Innovative technology platforms to optimise yields, boost product potency, increase development speed, or cut manufacturing costs; all independently licensable.

Integrated cell line and process development Pharmaceutical cell line development platform based on proprietary, royalty-free expression vector technology, various pre-selected CHO host cells, and own chemically defined media platform. Excellent reputation of cell line development skills based on fine-tuned, individually adjusted clone selection procedures and early integration of upstream and downstream selection parameters. This allows selecting the optimal expression strategy for each protein and enables rapid, economic upstream process development.

Reliable and flexible contract manufacturing Offers GMP production in fully state-of-the art disposable systems in fed-batch and continuous processes in up to 1,000 L bioreactors, incl: ·· Downstream Process Development

Probiogen

We Wemake makeour ourexperience experienceyours. yours.

·· Cell Banking (MCB/WCB) ·· GMP Manufacturing ·· Analytical Development Cell-based activity assays An range of cell-based activity assays for potency and mode-of-action analyses is established.

Technologies GlymaxX® ADCC Enhancement Glyco-engineering technology preventing cellular fucose synthesis and thus antibody fucosylation for maximised ADCC cell-killing activity against tumour and infected cells. Works for novel and existing producer cell lines, external expression platforms, or can be licensed alone.

Glyco-engineering Fucose, galactose, and sialic acid levels of glyco-proteins can each be adjusted, e.g. in biosimilar projects.

C-LiNK® ADC/Protein conjugation Novel advantageous site-specific, enzymatic ADC/ Protein conjugation technology. Royalty-free for any protein and any payload.

Productivity-boosting pathway modulator Stable introduction of an engineered cdc42 enzyme typically increases cellular productivity 2-fold. Just as GlymaxX® applicable to existing cell lines and expression platforms, independently licensable.

Human artificial lymph node: immunofunction Fully human mini-bioreactor technology to test longterm drug effects on the immune system in vitro. Unique 3D-matrix-assisted system uses primary cells to mimic immune reactivity in vivo, to analyse immunogenicity, immune-modulation, and -toxicity.

AGE1.CR® viral vaccine manufacturing platform AGE1.CR® duck cell line replaces primary chicken fibroblasts for GMP-compliant viral vaccine production, incl. highly attenuated ones, e.g. MVA and viral vectors.

Chemically defined media platform and scalable suspension processes for industrial production.

7 th european biotechnology guide 2017

126 | 127

Name · ProDigest BVBA

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Technologiepark 3 9052 Gent Belgium Sam Possemiers +32-9-24111-90 +32-9-24111-91 info@prodigest.eu www.prodigest.eu

LI 15 2008 Contract research activites Functional food/feed and pharma

ProDigest is a product leader in the development of unique laboratory models of the human and animal gastrointestinal (GI) tract. Complementary to in vivo studies, these models offer unique insight in gut processes associated to the intestinal fate, metabolism and bioavailability of actives. Moreover, the complete gut microbiota under controlled conditions and its link with human and animal health can be studied using these models. ProDigest is globally active as a service provider for functional food, feed and pharmaceutical companies and since 2014, has also installed its technology platform (Simulator of the Human Intestinal Microbial Ecosystem – SHIME ® ) in selected R&D facilities around the world.

The SHIME ® is a scientifically validated, computercontrolled dynamic model consisting of five reactors which sequentially simulate the stomach, the small intestine and the three main regions of the large intestine, i.e. the ascending, transverse and descending colon.

Further improvements of this technology platform led to the development of i) the so-called TWIN- and TripleSHIME ® (i.e. 2 or 3 SHIME systems running in parallel to perform parallel studies under identical environmental conditions), ii) the M-SHIME, which allows a simulation of the mucosal surface normally covering the gut wall and iii) the combination of these simulators with human cell lines/biopsies (i.e. co-cultures of enterocytes and macrophages; HMI™ module; Ussing chamber) to assess the effect of specific actives in terms of gut wall permeation, inflammation, bioavailability, satiety, etc …

Member of

European Biotechnology NET WORK

The system originally developed to simulate the full GI tract of healthy adults has today been adapted to reproduce physiological and microbiological parameters of babies, the elderly and patients with diseases that affect GI tract (i.e. Clostridium difficile infection, chronic inflammation, antibiotic treatment …). Furthermore, the technology has been expanded to hosts other than humans, such as production (e.g. pigs) and companion animals (e.g. dogs and cats).

Prodigest

The high flexibility of the SHIME® technology platform allows custom-made projects designed to reach specific scientific endpoints.

Typical experiments consist of introducing an API, a probiotic, a fiber or a functional ingredient into the system in a single or repeated dose strategy, for short- or long-term simulations of oral ingestion of the compound, to assess: ·· The effect of actives on the composition and metabolism of the gastrointestinal microbial community ·· The main area of activity of a functional ingredient in the GI tract ·· Stability, dissolution, targeted delivery and bioavailability of actives along the GI tract under either simulated fasted or fed conditions. ·· The impact of actives on colonisation resistance ·· The capability of a probiotic to compete with the autochthonous luminal and mucosal microbiota ·· The effect of interindividual variability on the activity/ efficacy of a specific treatment ·· The effect of actives on immune-modulation, satiety, cardiovascular diseases and gut-wall functionality ·· The anti-pathogenic activity of actives along the full GI tract ·· The pharmacokinetic behaviour of a specific API ·· Study of bacterial adhesion processes and hostmicrobiota interaction Next to the SHIME ® technology platform, ProDigest coordinates animal studies (e.g. Human Microflora Associated animals) and human clinical trials.

Furthermore, ProDigest has set up a number of in-house product development projects in relation to microbial biotechnology and gut microbiota management and the development of novel biotherapeutics.

7 th european biotechnology guide 2017

128 | 129

Name · PROGEN Biotechnik GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Maaßstraße 30 69123 Heidelberg Germany Katja Betts +49-6221-8278-16 +49-6221-8278-24 betts@progen.de www.progen.de

F L I 21 1983 S1, S2, L2 class laboratories, DIN ISO 13485 certification for the production of in vitro diagnostic kits and research reagents.

Areas of Activity · Antibodies and reagents for biomedical research, in vitro diagnostics, ELISA, AAV gene therapy tools, antibody phage display technology, density gradient media.

Annual Turnover · €2.8m External · Strong network with industrial and Collaborations academic institutions.

Request for · PROGEN is actively seeking partners Further Collaborations for the advancement and distribution of its antibody-based products & services.

Research antibody pioneer Since 1983, PROGEN has been an established manufacturer and supplier of premium antibodies, in vitro diagnostics, and reagents for the global life science research community. The company’s portfolio attracts and serves a well-diversified clientele in research institutes and universities, pharmaceutical and biotech companies as well as private and clinical laboratories.

While PROGEN’s antibodies are among the most published antibodies in biomedical and cell biology literature, its ELISA kits aim at niche markets in microbiology, infectious diseases and immunology. Building on its extensive core-competency and experience in immunochemistry, the company has expanded its product and service portfolio in recent years to include recombinant antibody engineering, antibody phage display technology, density gradient media, and AAV test kits for gene therapy research.

New areas of expertise: AAV-based tools and phage display technology Adeno-associated viruses are widely used for gene delivery in mammalian cells. Purification and capsid titer determination of AAV-vectors are critical steps for the assessment of correct AAV-concentrations, especially in the development of safe and effective gene therapies. PROGEN offers a unique range of AAV-titration ELISA kits that specifically recognise intact AAV particles. These ELISA kits have earned reference standard status in gene therapy centres worldwide. As the field of gene therapy advances, PROGEN continues to develop key tools for AAV-based research and development.

The hyperphage technology has revolutionised the generation and engineering of specific monoclonal antibodies in recent years. It improves antibody presentation in phage display by dramatically increasing the number of antibodies displayed per phage particle, thus representing a leap forward in functional gene analysis and proteomics. In cancer research for example, hyperphage-packed libraries are used to discover new tumour markers. In order to meet the growing demand in

Progen

passion for research these research areas, PROGEN is offering hyperphage technology as an effective tool for the generation of recombinant antibodies, proteins or peptides.

Commitment to quality & service PROGEN’s longstanding success is based on premium products and individual services by trained and experienced personnel. The production area (S1, S2, L2 class laboratories) is qualified for manufacturing under quality assurance conditions according to DIN ISO 13485 for the production of in vitro diagnostic devices and research reagents. Rigorous quality management and quality control systems combined with reliable, individual pre- and post-sales support ensure high customer satisfaction.

Collaborations to meet existing and future demands

Antibodies AAV-Tools Phage display technology ELISA Density gradient media

Since 2012, PROGEN has been a 100% subsidiary of the R-Biopharm AG based in Darmstadt/Germany, a developer of test solutions for clinical diagnostics and food & feed analysis. This corporate affiliation offers new possibilities for the growth of PROGEN’s product & service portfolio. In addition, Dr Sven Kuhlendahl, PROGEN’s general manager since 2014, intends to expand the stable network in academia and industry that has been established over the past 34 years: the company is actively seeking strong collaborators to develop novel antibody-based technologies and applications in order to strengthen its pipeline of life science reagents.

Together with its partners, PROGEN aims to support and extend existing markets as well as to enter new ones.

Together with its partners, PROGEN aims to enter new markets.

www.progen.de 7 th european biotechnology guide 2017

130 | 131

Name · ProQinase GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Breisacher Str. 117 79106 Freiburg Germany Dr Christoph Schächtele +49-761-206-1780 +49-761-206-1781 info@proqinase.com www.proqinase.com

I 37 2001 Drug discovery in oncology with a focus on protein kinase inhibitors

External · Multiple collaborations with academic Collaborations institutions and biotech companies Request for · Together with experienced chemistry Further Collaborations providers, ProQinase offers collaboration for integrated drug discovery projects in oncology up to demonstration of efficacy in animal models

Company mission It is ProQinase’s mission to be a leading solution provider for drug discovery in oncology with a major focus on the development of protein kinase inhibitors.

History ProQinase was founded in 2001 as a 100% subsidiary of the Tumor Biology Center Freiburg. In 2015 the company was acquired by Chinese investors. The company’s unique cancer drug discovery platform is ideal to develop novel therapeutic agents for tumour therapy. In the past, this platform has successfully been used for internal drug development projects. For some years now, ProQinase’s focus is on the fee-for-service business.

Products & services ProQinase offers a unique panel of tools and services for drug discovery in oncology: Recombinant Proteins ·· Recombinant protein kinases which can be used for biochemical kinase assays ·· Lipid kinases ·· Recombinant substrates for protein kinase activity assays Biochemical Assay Services Biochemical kinase assay services for identification and characterisation of small molecule kinase inhibitors ·· Radiometric assay technology ·· Totally flexible projects (any numbers of kinases, cpds., conc. and replicates) ·· Standardised whole kinase panel profiling with 410 protein kinases and lipid kinases Cell-based Assay Services ·· Target-specific cellular phosphorylation assays ·· Cell proliferation assays ·· Soft agar assays ·· Cell migration assays ·· 3D Tumor spheroid assays ·· Cellular angiogenesis assay

Proqinase

Syngeneic & Xenogeneic In Vivo Models ·· Subcutaneous tumour models ·· Orthotopic tumour models ·· Metastasis tumour models ·· In vivo angiogenesis model ·· Immuno-oncology platform

Worldwide customers ProQinase offers its tools and services worldwide to pharmaceutical and biotech companies of any size, as well as to academic institutes. In 2016, 8 of the top 10 pharma companies used ProQinase’s services.

Business models ProQinase offers any product or single service module on a fee-for-service basis.

In addition, ProQinase strives for long-term relationships with clients which are interested in integrated cancer drug discovery projects starting from hit identification up to proof of concept in animal models.

Personnel Our team of internationally trained scientists has more than 20 years experience in cancer drug development.

The focus of our scientific experience is on protein kinase and angiogenesis research.

We believe that this makes us a qualified and reliable partner for cancer drug discovery targeting protein kinases and other target molecules.

7 th european biotechnology guide 2017

132 | 133

Name · ProtATonce

Address/P.O. Box · Science Park Leukippos-Demokritos, Patriarchou Grigoriou & Neapoleos Postal Code/City · 15343 Ag. Paraskevi / Athnes Country · Greece Contact Person · Stamatatou Sophia Telephone · +30-2109610307 Email Address · info@protatonce.com Internet Website · www.protatonce.com Social Media · F I Number of Employees · 8 Founded (year) · 2012 Type of Laboratory · Biotechnology Areas of Activity · l Drug discovery l Biomarker discovery l Multiplex assays l Multi-omics data analysis Annual Turnover · €650,000 Relevant R&D Budget · €250,000 Biological Patents · IP on multiplex assays, target for melanoma, biomarker for cardiovascular disease External · Harvard Medical School, Collaborations Top pharma companies Request for · Melanoma & Cardiovascular Disease Further Collaborations

The art in multiplexed assays ProtATonce is an in-vitro drug discovery solutions provider for biomarker and target analysis. Using advanced systems pharmacology analyses and state-of-the-art facilities we provide solid and experimentally proved answers for biomarker performance, drug efficacy and toxicity, target identification, drug mode of action, and drug repositioning.

ProtATonce services are based on the generation and analysis of multi-omics data under a systems biology framework. Our state-of-the-art multi-omics facilities, unique expertise in multiplexed proteomic and phosphoproteomic assays, advanced computational tools, and happy customers guarantee a unique high-quality service as described below.

Testing services ProtATonce has more than 1000 in-vitro assays that range from cytokine measurements, cell viability, and disease-panels to signalling measurements. Our A-to-Z testing services include tissue culture, high content screening, and measurements in any type of biological fluid (i.e. serum, plasma, supernatant, BALF, urine), as well as solid tissue samples (i.e. solid tumours, fat tissue, etc).

Protatonce

Multiplex assay development We can build any type of multiplex panel using a proprietary method that guarantees minimum antibody cross-reactivity. Two different types of assays are offered: single-antibody assays, where thousands of targets are measured in <50ul of sample, and dualantibody assays, where up to 50 assays can be measured with high quality.

Systems pharmacology analysis ProtATonce has streamlined multi-omics data analysis and offers a variety of computational tools, from data visualization, quality control analysis, and statistics, up to advanced systems biology computational tools for drug discovery, including pathway construction, mode of action, prediction of efficacy/toxicity, and target/lead identification and validation. We speak in plain language to your scientists and we apply the most advanced computational tools to analyse your data. Our MIT and Harvard trained personnel with multidisciplinary expertise in biology and computer science, our strong publication record, and our international awards in computational analysis guarantee a strong partner for your data analysis needs.

7 th european biotechnology guide 2017

134 | 135

Name · Provecs Medical GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Martinistraße 64 20251 Hamburg Germany Dr Frank Schnieders +49-40-4126-3268-0 info@provecs.com www.provecs.com

Immuno-Oncology – How to target the tumour microenvironment?

Life-threatening cancer diseases develop when the body’s immune defense is turned off and tumour growth proceeds unchecked. After the era of drugs targeting cancer cell functions to suppress tumour growth, the next major goal in cancer therapy is to target the immune cells, in order to re-establish immune control and defence against tumour cells. The activation and inhibition of defensive immune cells is regulated by a wealth of molecules regarded as checkpoints for immune regulation. Blocking inhibitory checkpoints with antibodies shows that immune control and defence can be restored. For patients with cancer of the skin (melanoma) this treatment can double of their long-term survival time. Major challenges in this field are now the identification and the efficient targeting of drugs to reprogramme immune checkpoints towards defence and tumour destruction. The classical single-drug/singletarget concept is insufficient to effect a cure and needs to be replaced by combinations of drugs acting in the tumour-suppressive immune microenvironment.

the environment for immunotherapy I

10 2007 R&D, Laboratory S1 and S2 l Immuno-Oncology l Vector Development l Gene Therapy l Transcriptome Studies (NGS) l Bioinformatics l Immuno Profiling

Provecs’s ENVIRO platform – unique drug options

©

2016

CONFIDENTIAL

Provecs Medical is a biopharmaceutical company specialised in the development of novel immunotherapies addressing the cancer microenvironment with drug technology for multi-target immune checkpoint therapy.

Based on its multivalent adenoviral ENVIRO technology platform, the company has developed rapid and efficient solutions to reprogramme the barriers between the immune system and cancer. In a unique method, up to 4 checkpoints can be addressed with one biological product. Our first candidate Immunalon® was developed for the treatment of a wide range of solid cancers, with a focus on urinary bladder cancer.

provecs medical

Provecs’s EXVIRO platform – unique high-content testing options Provecs Medical’s EXVIRO platform is a unique primary cancer tissue platform for ex vivo therapy simulation and PD and PK studies. This 3D tissue culture system for patient-derived human cancer tissues enables studies on the tumour microenvironment in its spatial context, without disrupting the cellular relationships.

The EXVIRO platform delivers comprehensive whole genome expression data, cellular profiles, and molecular biomarker signatures through bioinformatics-based transcriptome analyses and immune cell phenotyping.

Today, 77 patients have been enrolled in the ex vivo tissue study, with more than 400 tissue specimens studied in individual conditions, e.g. dosing, target cell profile, immune activation, and associated pathway analyses.

A high level of responders has been found and response gene biomarker signatures have been identified. With this unique data set, Provecs Medical provides a solid basis for target indication screening and clinical development.

Business directions In 2016 Provecs Medical has out-licensed its product Immunalon® to a German pharma partner for cancers of the urinary bladder. This partnership covers the entire further product development and marketing. With the ex-vivo proof-of-concept data, Provecs is open to partnering Immunalon® for different indications. In a second indication, a first-in-man study concept is currently being developed for intratumoural therapy with Immunalon®. The company is seeking partners for development of therapy options for Immunalon® in other solid cancer indications with high medical need and a lack of standard therapies.

7 th european biotechnology guide 2017

136 | 137

Name · Recipharm OnTarget Chemistry

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · ·

Virdings alle 16 (visit) / 32b (post) 754 50 Uppsala Sweden Ulrika Lehmann +46-700-920509 info@ontargetchemistry.com www.ontargetchemistry.com 50 2009 Synthesis and analytical Chemistry CRO

Recipharm OnTarget Chemistry was established as a spin-off from the medicinal chemistry, combinatorial chemistry and preclinical analysis departments of Pharmacia (Biovitrum). In 2015 OnTarget established a facility in Ness Ziona (Israel) that currently employes 10 chemists and was also acquired in whole by Recipharm, a leading CRO/CMO, headquartered in Sweden with 15 production facilities around Europe.

Currently we have grown to a staff of 40 chemists in Sweden and an additional 10 in Israel.

Recipharm OT Chemistry, continues to grow and employ some of the industry’s most experienced chemists and runs a tight organisation with solid values of service, quality, and efficiency.

OnTarget has: ·· Run over 1,200 projects to date for 100+ customers in 15 countries, including the US and China ·· A success rate of over 99% ·· Six projects delivered over the last four years currently in clinical trials ·· 95% repeat business ·· Chemistry services including: · Medicinal Chemistry · exploring SAR · scaffold jumping · parallel chemistry · patent examples · metabolites, etc. ·· Synthesis of reference compounds ·· Non-GMP scale-up synthesis, adaption of lab scale to conditions suitable for kg scale production and production up to a few kg scale ·· Route scouting, optimisation of reaction conditions and critical process parameters ·· Screening of crystallisation conditions, with different salts and solvents ·· Labelling with 2H, 3H, 14C and more for use as internal standards and tools for both in vivo and in vitro studies

Member of

European Biotechnology NET WORK

Preclinical services include: ·· Capacity and resources to run a complete medicinal chemistry project, including:

Recipharm OnTarget Chemistry

· M TS solubility in various buffers (saline, PBS, SIF, SGF, etc.) · Protein binding studies (microdialysis equilibrium method)

Recipharm OnTarget Chemistry ·· Stability studies in plasma and whole blood ·· Development and synthesis of derivatisation agent to improve analyte quantification ·· Metabolic profiling using primary hepatocytes/microsomes ·· Non GxP bioanalysis, using LCMS, GCMS, or LC-MS/ MS ·· Autoradiography and mass balance studies ·· Formulation development for IV/IP/SC administration GLP Bioanalytical services includes: Bioanalytical sample analysis in plasma and urine in accordance with GLP and relevant ICH, EMEA, and FDA guidelines with the laboratory duly audited by all relevant agencies.

OnTarget offers: ·· Method development for partners without their own bioanalysis method, or method transfer for existing methods, followed by validation according to FDA and EMA Guidelines ·· The highest quality bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices ·· Support for pre-clinical studies meeting full GLP requirements and small sample volumes, as well as for clinical studies with large numbers of samples such as bio-equivalency and bioavailability studies ·· Bioanalytical support for clinical dose escalation studies (SAD and MAD) with short turnaround times and small sample volumes ·· Dosing solution analysis for GLP studies ·· Synthesis of internal standards, either stable isotopelabelled or suitable analogue ·· Automated 96-well sample processing and analysis ·· Cutting edge technology with automated and analytical instrumentation (high sensitivity and specificity with LC-MS/MS) 7 th european biotechnology guide 2017

138 | 139

Name · Redx Pharma Plc

Address/P.O. Box · Block 33F Mereside Alderley Park Alderley Edge Postal Code/City · SK10 4TG Macclesfield Country · United Kingdom Contact Person · Mark Craighead Telephone · +44-0162-523-8990 Email · m.craighead@redxpharma.com Website · www.redxpharma.com Number of Employees · 150 Founded (year) · 2010 Type of Laboratory · l Medicinal chemistry l Pharmacology l DMPK Areas of Activity · Drug development Annual Turnover · £2.6m External · l Royal Liverpool and Collaborations Broadgreen University l Hospitals Trust l Pharmascience l Pierre-Fabre Innovative Medicines Initiative: l ENABLE, l Astra Zeneca Request for · Redx is interested in developing early Further Collaborations stage hits to PoC prior to partnering.

Our major areas of reasearch are: Oncology, Anti-Infectives and Immunology

Member of

European Biotechnology NET WORK

Redx is a drug development company that is creating new pipeline assets for large and emerging pharmaceutical companies in response to the changing pharma R&D landscape. The company’s approach has been validated by the signing of a number of commercial deals, including a significant collaboration with AstraZeneca as well as Horizon Discovery and the NHS. The business operates through three subsidiaries – Redx Oncology, focused on anti-cancer drugs, Redx AntiInfectives, which is the largest research group in the UK developing new antibiotics, and Redx Immunology, which focuses upon Immuno-Oncology as well as antifibrotic disease. A fourth subsidiary, Redx Crop Protection, was successfully spun out in September 2014, attracting new investment and generating returns for Redx shareholders, and now operates as RedAg Ltd. Our successful share placing and flotation on AIM in March 2015 established a firm foundation for on-going growth and consolidated the work we had done since establishing Redx in 2010. The Redx pipeline advanced significantly in 2015, with the achievement of in vivo PoC in two programmes as well as the progression of three drug candidates into pre-clinical development.

Since 2014, Redx has been a key player in an Innovative Medicines Initiative (IMI) known as ENABLE, a European consortium to tackle antibiotic resistance. The group includes over 30 European universities, research institutes, and companies, led by GlaxoSmithKline and Sanofi, in a six-year programme to develop novel antibiotics to tackle the critical threat of Antimicrobial Resistance (AMR) in Gram-negative bacteria.

Our Anti-Infective group has recently progressed in identifying novel compounds with efficacy against drug resistant strains of Gram-negative bacteria. This could have important implications for drug-resistant infections such as E. coli and Pseudomonas, which are responsible for critical illnesses including pneumonia, blood poisoning, and urinary tract and abdominal infections. In a pre-clinical study there was a significant decrease in bacterial infection levels against a multi-drug resistant

redx pharma

Gram-negative bacterial strain when compared with tigecycline, a current drug-of-last-resort used in treating antibiotic-resistant bacteria.

Redx’s cancer research pipeline is extremely strong, with a focus on drugs that trigger the body’s immune system to tackle tumours and that target cancer stem cells which are responsible for tumour recurrence. These areas are at the forefront of current approaches to cancer therapy and, over the next five years, we expect to see multiple programmes progressing to clinical studies and delivering collaboration revenues through partnering deals.

The oncology team has recently announced the identification of a novel porcupine inhibitor which exhibits potent and selective inhibition of the Wnt pathway in in vitro and in vivo models of Wnt dependent pancreatic cancer. Preliminary results indicate that the compound may also enhance the efficacy of checkpoint inhibitors, such as anti-PD-1 antibodies, by reducing the proportion of regulatory T cells in the tumour microenvironment and enhancing the ratio of cytotoxic T cells to regulatory T cells in tumour infiltrates. The company is progressing studies to prepare the RXC004 programme for first-in-human clinical trials with the aim of commencing such trials in 2017.

In May 2015, Redx announced the launch of a third area of research in immunology. This allows the team to build upon the successes already seen in oncology and antiinfectives research. The immunology group is based at Alderley Park and is supported by a £4.2m grant from the UK Government’s Regional Growth Fund.

Redx is actively looking for new partners/projects in our therapeutic areas, which will allow us to bring assets from the early-hit stage through to PoC. With our expertise and strength in areas such as medicinal chemistry, biology, and DMPK, we feel we can be an excellent partner and add value to any programme.

7 th european biotechnology guide 2017

140 | 141

Name · Rentschler Biotechnologie GmbH

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · · ·

Erwin-Rentschler-Str. 21 88471 Laupheim Germany Dr Marion Schrader +49-7392-701-0 +49-7392-701-300 info@rentscher.de www.rentschler.de

I 700 1927 S1 l Contract bioprocess development and manufacturing partner of biopharmaceuticals focused on mammalian cell culture l Aseptic filling of biopharmaceuticals l Project management l Global regulatory support

External · Leucokare AG, located in Munich, Collaborations a German biotech company providing a formulation technology platform Request for · Rentschler is seeking pharma and Further Collaborations biotech companies needing bioprocess development and cGMP manufacturing solutions and interesting in long-term collaboration

Passion for Performance Rentschler is a biotechnology pioneer, specialising in mammalian cell culture with expertise in recombinant proteins. As a full-service Contract Development and Manufacturing Organisation (CDMO) the company is a proven outsourcing partner and one of the leaders in the industry. Focused on the bioprocess development and manufacturing of biopharmaceuticals, we support our global clients through to market approval of their products. The Company’s clients include innovative biotech companies as well as major pharmaceutical companies around the world.

Rentschler provides an essential contribution to the global availability of biopharmaceuticals and thereby help millions of people each day. Founded in 1927, Rentschler is a family-owned company located in Laupheim, Germany employing approximately 700 people.

Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler’s high quality standards.

Full-service concept Rentschler’s full-service offering covers all activities from bioprocess development through to manufacturing, analytical characterisation, and fill & finish. Our experience covers the manufacturing of recombinant proteins such as monoclonal antibodies, fusion proteins, cytokines, and enzymes in compliance with international cGMP standards (EMA/FDA). The state-of-theart cGMP facilities and cell culture processes allow us to manufacture material for clinical phases and commercial supplies. Constant monitoring of regulatory environments and deep experience in the creation of approval documents at an international level ensures that each project is documented in accordance with regulatory requirements.

Our alliance with Leukocare AG strategically aims to incorporate formulation development at every step throughout biopharmaceutical development and manufacturing. Working closely with the client, this will ensure that the end products will – from the very beginning – have a best-in-class formulation and administration

Rentschler

mode. This innovative approach will provide clients significant competitive advantages, enabling them to exploit the full potential of their products and markets.

Rentschler solutions Rentschler offers comprehensive expertise in the bioprocess development and manufacturing of biopharmaceuticals as well as long experience in the creation of approval documents at an international level.

Bioprocess development ·· Development of production cell lines ·· Development and optimisation of cell culture and purification processes ·· Process characterisation and validation ·· Development of formulations for clinical phases ·· Development, qualification, and validation of analytical methods cGMP manufacturing and aseptic filling ·· Clinical and commercial drug substance manufacturing ·· Stainless steel bioreactors up to 3,000 L ·· Single-use bioreactors up to 2,000 L ·· Fed-batch and continuous processing ·· State-of-the-art purification processes ·· Production, testing, and storage of master and working cell banks ·· Aseptic liquid filling in vials and lyophilisates Quality control and analytical characterisation ·· Complete analytical characterisation of biopharmaceuticals ·· Drug product/drug substance release testing ·· Comparability and stability studies Consulting services ·· Detailed and reliable consulting and planning in every phase of client projects ·· Managing all aspects of the project, including monitoring the timeline, goals, and budget ·· Regulatory support including advice and assistance with regulatory questions, and generation of complete documentation for approval (IND/IMPD CMC parts) 7 th european biotechnology guide 2017

142 | 143

Name · Richter-Helm BioLogics GmbH & Co. KG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email

· · · · · · ·

Website Number of Employees Founded (year) Areas of Activity

· · · ·

Suhrenkamp 59 22335 Hamburg Germany Dr Kai Pohlmeyer +49-40-55290-430 +49-40-55290-888 k.pohlmeyer@ richter-helm-biologics.eu www.richter-helm.eu 160 1987 Contract development and manufacturing of biopharmaceuticals derived from microbial systems

Biological Patents · Several patents on manufacture of recombinant proteins with which Richter-Helm is working External · Biotech and Pharma companies Collaborations worldwide Request for · Richter-Helm’s Business Development Further Collaborations team will be pleased to learn more about your projects as well as how we can find solutions to fulfil your specific needs and bring your project one step further.

For more detailed information please contact us.

Company profile Richter-Helm is a German Biotech company with more than 25 years of experience in the development and manufacturing of products derived from microbial expression systems (bacteria and yeasts).

Thereby Richter-Helm provides contract development and manufacturing services for different product classes (e.g. recombinant proteins, plasmid DNA, small antibody formats, vaccines) for all clinical stages as well as for commercial supply.

With an experienced team of more than 150 employees Richter-Helm offers customised services with highest pharmaceutical quality standards confirmed by leading regulatory authorities (e.g. EMA, FDA, ANVISA, MFDS).

In addition, Richter-Helm is the platform of its mother companies Gedeon Richter and Helm AG for worldwide licensing options as well as partnerships for co-development and marketing of microbial derived biopharmaceutical projects.

Richter-Helm

Products and services The teams at Richter-Helm have excellent expertise in development and GMP-compliant production of biologicals and biosimilars.

Therefore Richter-Helm offers a full range of biopharmaceutical services: ·· Strain development (e.g. E.coli, P. pastoris) ·· Establishment of cell banks (MCB/WCB) ·· Process development (USP/DSP) ·· Process optimisation ·· Development of analytical methods (incl. biological assays) ·· Validation of analytical methods ·· In-house QC testing and release ·· GMP manufacturing for phase I to III ·· Commercial GMP manufacturing ·· Process characterisation ·· Process validation ·· Stability studies according to ICH ·· Regulatory support Due to the broad knowledge of Richter-Helm’s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailor-made solutions for its customers.

Hereby each project is treated individually and with the highest flexibility from RHB’s site.

7 th european biotechnology guide 2017

144 | 145

Name · Rotoinox d.o.o.

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Areas of Activity

· · · · · · · · · · · ·

Prvomajska ulica 39 5000 Nova Gorica Slovenia Mr Blaz Pavsic +386-5-330-63-50 +386-5-330-63 56 info@rotoinox.com www.rotoinox.com

I 32 1979 Engineering, manufacturing, and assembling systems and equipment for the pharmaceutical, chemical, and biotechnology industries

International engineering and manufacturing company Rotoinox is an engineering and manufacturing company that specialises in producing and designing innovative solutions and high-quality products for the pharmaceutical, chemical and biotechnology industries.

Over a proven track record of 38 years, the company has designed, manufactured, and commissioned many of the most ambitious European projects and has set standards in the industry at every level. What makes the company outstanding are its high quality and innovative solutions, a genuine passion for the work, and a commitment to a reliable partnership that puts people and valuable relationships first – a value that has been strongly rooted in the founders of the company and has been passed on to the younger generations of the company’s leaders.

Over the years Rotoinox has grown from a small familyowned business into an international engineering and manufacturing company that today provides innovative solutions for the largest pharmaceutical corporations worldwide.

Areas of expertise With its deep understanding of specific processes, engineering and manufacturing know-how, and a long track record of expertise in the field, Rotoinox offers a large scope of services and products.

Over the years the company has developed a reliable and effective process engineering system that provides high-quality solutions with a long life span. The system includes Conceptual Design, Basic Engineering, Detail Engineering, Implementation, Quality Control, and IQ and OQ Qualifications.

Company services at a glance ·· Engineering uniform solutions in accordance with customer requests ·· Manufacturing high-quality products in high-alloy materials ·· Providing the best welding solutions ·· Implementing meticulous surface treatment ·· Providing standardised and on-going quality control ·· Offering innovative solutions for vessel cleanability

Rotoinox

Core products ·· Pharmaceutical process vessels ·· Pharmaceutical mobile process vessels ·· Bioreactors ·· API reactors ·· Filter units ·· IBC systems ·· Material handling ·· Process systems

Dedicated to providing the highest quality products and services Rotoinox has been ISO 9001 certified since 2005, demonstrating its commitment to consistently providing high-quality products and innovative services that meet the needs and expectations of its clients.

To ensure the highest quality the company has a large team of experts that make sure that the highest standards are met at every step of the process. The quality control group ensures that all facilities, equipment, and critical materials are under control and cGMP and ASME BPEcompliant, whereas the quality assurance group secures that all manufacturing fulfils cGMP/ GEP and ASME BPE requirements and meets clients’ quality expectations.

Other key Rotoinox quality certificates include the Quality Welding Management System certified according to EN 3834-2 and manufacturing pressure equipment certified to the Pressure Equipment Directive 2014/68/ EU and AD 2000.

Leading expertise in the field The commitment to producing and designing highquality and innovative solutions can only be achieved with a great body of experts. That’s why Rotoinox employs only the best-qualified and most competent experts in the field. Over the years the company has managed to establish a strong work-force made up of highly motivated and experienced individuals who have helped to set the standards in the industry and to reshape it with better and more reliable solutions.

7 th european biotechnology guide 2017

146 | 147

LI

SimplicityBio is a Swiss company active in the discovery of novel medical biomarkers by means of its patented bioinformatics machine-learning technology. Disease complexity is undermining the efficacy of diagnostics and drugs. Using our unique Biomarker Optimisation Software System – BOSS™, we discover and associate novel biomarkers in patient data. The models discovered capture biology’s complexity and are out-licensed to revolution accurate diagnostics, decrease drug development costs and increase treatment efficacy.

5 2015 In-silico Biomarker discovery

Technology – New diagnostics and drugs are built on multiple biomarker models

Name · SimplicityBio SA

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · · ·

Route de l’Ile-aux-Bois 1A 1870 Monthey Switzerland Matthew Hall +41-76-241-03-25 matthew.hall@simplicitybio.com www.simplicitybio.com

There is a plethora of published traditional biological markers but very few have entered the clinic in the last 30 years. On the other hand, the development of ‘omics technologies generates a massive, growing and greatly untapped reservoir of data, allowing the emergence of new biomarkers that are actually the combination of multiple ‘omics data and patient data, thereby forming a biomarker model. These models increase significantly the performance of diagnostic and provide the doctors with tests to robustly separate patients to give the right diagnostic or the right treatment, e.g. healthy and cancer patients, or responders and non-responders.

SimplicityBio’s BOSS™ captures biological complexity by systematically exploring billions of potential biomarker models, optimising and selecting the ones that can robustly separate patients and are tailored to market needs (e.g. maximal number of biomarkers, minimal AUC, requiered sensitivity or specificity). The BOSS™ platform is technology and data agnostic, integrating omics to clinical data, without a priori knowledge and that the patented selection method of the models provides unmatched robustness, even in early disease stages.

Simplicitybio

Pipeline SimplicityBioâ&#x20AC;&#x2122;s pipeline is composed of two arms, that both take advantage of our unique BOSSâ&#x201E;˘ platform.

Co-developed pipeline In collaboration with our customers we are developing companion diagnostics models against upfront and milestones. Our customers market the diagnostic kits that then generate royalties. From 2015, we have successfully built a pipeline of royalty-generating models in various fields including breast cancer stratification, prostate cancer screening, heart failure relapse, thyroid cancer and multiple myeloma companion diagnostics â&#x20AC;&#x201C; CDx. Out-licensing pipeline SimplicityBio develops clinically validated & ready to be out-licensed models. We select carefully the therapeutic areas in conjunction with our scientific advisory board, to provide models responding to clear unmet medical needs. This pipeline is tackling today 3 areas in oncology: AML (Acute Myeloid Leukaemia) treatment resistance, lung cancer confirmatory diagnosis and breast cancer recurrence prediction. These models are outlicensed on an upfront, milestone and royalties basis.

SimplicityBio allows diagnostic and pharmaceutical companies to build accurate diagnostic and stratification tools for the medical community, by leveraging the astonishing volumes of data produced today to capture disease complexity.

7 th european biotechnology guide 2017

148 | 149

Name · Swiss Biotech™

Address/P.O. Box Postal Code/City Country Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity

· · · · · · · · · ·

Stauffacherstrasse 16 8004 Zurich Switzerland +41-44-455-56-78 +41-44-786-16-81 info@swissbiotech.org www.swissbiotech.org 0.8 (FTE) 1998 National cluster development managed by Swiss Biotech Association

External · National and international Collaborations stakeholders of the Swiss Biotech Ecosystem Request for · National Thematic Network Further Collaborations Swiss BiotechTM

At the Glance Swiss Biotech™ offers ‘no wrong doors’ service and directs inquiries to the relevant target audiences. Powered by the national industry association (SBA), Swiss Biotech™ connects people and organisations efficiently.

The Swiss Biotech Association (SBA) was founded in March 1998. SBA is the industry association active in all areas of biotechnology and the networking platform for the multinational companies active in the sector.

Goals SBA recognises the significant economic potential of modern biotechnology. The industry association aims at identifying, communicating and utilising the advantages of modern biotechnology for the benefit of society.

SBA strives to influence and assist greater understanding of the industry’s comprehensive needs and to this end has working programmes with important stakeholders and organisation.

The stakeholder engagement extends beyond the Swiss geography through partnerships with global biotechnology associations, other national, regional and international networks.

SBA informs about current news and future events and special happenings in the industry through the portal www.swissbiotech.org, electronic newsletters and the online community for members.

Swiss Biotech

Joining the SBA

United forces lead to the summit 1Nation1Cluster

Swiss Biotech offers many paths to success.

Following the best route prooves to be the safest.

We can support your path to success in Switzerland.

Association membership is open to companies of various sizes concerned with different aspects of modern biotechnology such as R&D, production, marketing and sales, finance, services and consulting. Activities of member companies span different sectors of biotechnology including pharmaceuticals, industrial & environmental biotech, food & agriculture, bioequipment and -informatics, analytics and diagnostics as well as research and manufacturing services.

The SBA organises business and scientific network events with various partners interested in the needs of the industry. Within our thematic community platforms, such as the regulatory or the finance platform, members exchange and receive relevant information.

The association runs and supports national and international events to support the exchange between industry, academia and other cluster regions.

www.swissbiotech.org

United forces lead to the summit

7 th european biotechnology guide 2017

150 | 151

Name · TECOmedical Group AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) ISO certification Areas of Activity

· · · · · · · · · · · ·

Gewerbestrasse 10 4450 Sissach Switzerland Marieluise Wippermann, CEO +41-61-98581-00 +41-61-98581-09 wippermann@tecomedical.com www.tecomedical.com 16 1984 EN ISO 9001; EN ISO 13485 Providing specialty assays, assay systems and services to Pharma, Biotech, CROs, medical and research centres: | Custom Assay Development | Speciality Assays for Biosafety | Speciality Assays for Toxicology | Speciality Assays for (pre)clinical studies, research and diagnostics | Environmental Assays | Vitellogenin assays for endocrine disruptors in fish | Water assays for chemical substances

Biological Patents · | Pan-specific complement testing in animals (submitted) | Vitellogenin detection from mucosa (submitted)

Custom assay development & services Custom ELISA Assay development and Services are offered to organisations like Biotech companies, CROs, Pharma and Research institutions, requiring speciality assays and studies based on customer specifications. ·· Host Cell Protein ELISA testing for recombinant protein pharmaceuticals ·· Immunogenicity assays to test for: · Anti Drug Antibodies (ADA) ·· High sensitive ELISAs Assay Services include measurement of study samples, pilot to medium size manufacturing of ELISA kits and assay components.

Assays for (pre-)clinical and medical studies Drug development, research, diagnostics & therapy control ·· bone/calcium/cartilage metabolism ·· diabetes/obesity/metabolic syndrome ·· liver disease & apoptosis ·· drug-induced liver & kidney injury ·· complement system ·· cardiovascular disease ·· oxidative stress ·· growth metabolism

Assays for biosafety testing Medical devices, transplants, implants, pharmaceuticals and blood products ·· Haemocompatability related to activation of the ·· complement system – Anaphylatoxins ·· Complement activation related to pseudoallergy (CARPA) ·· Complement activation in animals (in vitro & in vivo) ·· Cytotoxicity

Assays for toxicology ·· Detection of drug induced liver injury (DILI) ·· Detection of drug induced kidney injury (DIKI)

Tecomedical

Environmental assays

Assay Services

(Pre) Clincial studies

Prevention

Biomarker assays

Biosafety

Custom assay development

Diagnosis

Disease Control

Toxicology

Monitoring

Drug Development

Specialty Assays

Company profile

Therapy

·· Fish assays for substances with endocrine disrupting potential ·· Detection of substances with estrogenic activities ·· First assay allowing non-destructive, non-invasive sampling from epidermal mucosa ·· Detection of Vitellogenin in blood, homogenates and mucus ·· Applications in ecotoxicological monitoring programmes ·· Efficiency control of sewage plants ·· REACH Vitellogenin ELISA: Specially designed assays for chemical testing according to OECD Guidelines (229, 230, 234) and EC regulation Nr. 440/2008 (REACH) from July 10th 2015 ·· Water assays for chemical substances

Education

Founded in 1984, the Swiss-based TECOmedical Group and the subsidiaries in Germany, France, Austria and Benelux provide assays and services for (pre)clinical studies, biosafety and toxicology studies, medical research and in vitro diagnostics. We offer an extensive portfolio of speciality assays, assay systems and services to Pharma and Biotech companies, CROs, medical and research centres.

With our speciality assays and custom assay development we support the entire development cycle of new therapeutic agents; from basic research in cell cultures (mono and 3-D) to animal models and from (pre-)clinical studies to therapy monitoring.

To offer an extensive portfolio of speciality assays, we work closely together with leading manufacturers. Speciality ELISA assays are also developed by our own R&D department in Germany.

7 th european biotechnology guide 2017

152 | 153

Name · TRN – The Research Network Limited

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity

· · · · · · · · · · ·

IPC600 Dicovery Park, Ramsgate Road CT13 9NJ, Sandwich Kent United Kingdom Andy McElroy +44-1304-892399 admin@trn.net www.trn.net 7 2011 Virtual Drug discovery and early development

Annual Turnover · $1MM Biological Patents · Not IP holding External · Many Collaborations Request for · TRN can assist with most aspects of Further Collaborations drug discovery & early development

Member of

European Biotechnology NET WORK

Drug discovery and development requires in-depth multi-disciplinary expertise which small companies and academic groups may not always have in-house. The Research Network (TRN) enables direct access to a global network of highly experienced pharmaceutical professionals of a wide range of pre-clinical and clinical skill sets.

Accessing expertise via TRN is a flexible cost efficient route to progressing your projects with high quality data from pre-clinical to clinical stages of development.

Within TRN you can work with one specific expert or the required network of expertise to move your project forward. TRN will help you to identify the most cost effective route to progress your project.

TRN offers; Integrated project and strategic management (Target identification to Clinical PoC), grant writing and submission support, >60 experts globally and established relationships with a wide range of CROs. (chemistry, biology, DMPK/ ADME, Drug Safety/ Toxicology, CMC Formulation, Regulatory & Clinical), Specific expertise in CVMD, Respiratory, Inflammation, Immunology, Virology, Dermatology, Pain, Oncology, CNS, Rare & Orphan Diseases, Small molecules and biologicals, TRN offers expertise gained in major pharma companies (Pfizer, AZ, Abbott, GSK, Millennium, Nycomed and others).

TRN

TRN offers pay-as you-go drug discovery with a simple efficient contracting process, access to a quality CRO facilities, You retain all intellectual property.

With itâ&#x20AC;&#x2122;s wide network and experience of many project and funding paradigms, TRN is well placed to find the right partners for your projects and to assist with securing funding.

7 th european biotechnology guide 2017

154 | 155

Name · UBM CPhI

Address/P.O. Box · CPhI Global Office De Entreé 73, Toren A Postal Code/City · 1101 BH Amsterdam Country · The Netherlands Contact Person · Ilona van den Berg Telephone · +31-20-40-99-507 Email · ilona.vandenberg@ubm.com Website · www.cphi.com Social Media · FL I  Number of Employees · UBM EMEA (>800) CPhI (ca. 100) Founded (year) · 1990 Areas of Activity · Pharmaceutical events Annual Turnover · Circa £1bn (UBM plc)

CPhI drives growth and innovation at every step of the global pharmaceutical supply chain, from drug discovery to finished dosage. Through exhibitions, conferences, and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities, and expand the global market. CPhI hosts events in Europe, North America, Korea, China, India, Japan, South East Asia, Turkey, and Russia and co-locates with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging, FDF for finished dosage formulations, and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com.

For more information visit: www.cphi.com.

The UBM EMEA annual schedule of pharmaceutical events includes: CPhI Istanbul (8–10 March, 2017 at the Istanbul Expo Center (IFM), Istanbul, Turkey). Co-located with ICSE, InnoPack, P-MEC, and BioPh CPhI South East Asia (22–24 March, 2017 at the Jakarta International Expo, Jakarta, Indonesia). Co-located with InnoPack, ICSE, P-MEC, and Hi South East Asia CPhI Russia @IPhEB (28–30 March, 2017 at JSC VDNH (VVC), Pavilion 75, Hall A, Moscow, Russia) CPhI Japan (19–21 April, 2017 at the Big Sight Exhibition Centre, Tokyo, Japan). Co-located with ICSE, P-MEC, BioPh, and InnoPack CPhI North America (16-18 May, 2017, Pennsylvania Convention Center Philadelphia, PA, USA) Co-located with ICSE, FDF, and Innopack CPhI & P-MEC China (20–22 June 2017, Shanghai New Int’l Expo Centre (SNIEC), Shanghai, China). Co-located with ICSE, BioPh, Innopack, L ABWorld, P-Logi, EP&CleanTech, nex, and Hi China CPhI Korea (22–24 August, 2017 at COEX Hall D, Seoul, Korea). Co-located with BioPh, ICSE, and P-MEC.

UBM CPhI

CPhI Worldwide (24–26 October, 2017, Messe Frankfurt, Germany). Co-located with ICSE, InnoPack, P-MEC, and FDF CPhI & P-MEC India (27–30 November, 2017, BEC and BKC Exhibition and Convention Centres, Mumbai, India).

Pharmapack Europe (7–8 February, 2018 at the Paris expo Porte de Versailles – Hall 7.1, Paris, France).

CPhI Worldwide is the biggest event in Pharma and represents all aspects of the pharmaceutical ingredients market with exhibitors covering ingredients, APIs, excipients, finished dosage, and more.

Other UBM brands include: ICSE connects the pharmaceutical community with outsourcing solution providers, offering a forum for business development, networking, and education.

InnoPack brings together buyers and specifiers from the packaging and pharmaceutical industries, creating business opportunities through a dedicated worldwide forum.

BioPh offers a natural business platform to the world of Pharma, focusing on biopharmaceutical development and services, both face-to-face and online.

P-MEC delivers innovative pharmaceutical machinery, equipment, and technology to a worldwide forum of decision makers through face-to-face networking and education.

LABWorld connects the pharmaceutical community active in laboratory, analytical, and biotechnology instrumentation, offering a forum for business development, networking, and education.

Finished Dosage Formulation (FDF) will become the first event to bring every aspect of the finished dosage supply chain together in one location.

Pharmapack is Europe’s pharma-dedicated packaging and drug delivery event: two days of innovation, networking, and education.

7 th european biotechnology guide 2017

156 | 157

Name · University of Birmingham’s OMICS Research Services & Training Centres

/, . #$("( Address/P.O. , - ,# Box · Edgbaston Postal Code/City · B15 2TT Birmingham Country · United Kingdom Contact Person · Joint Centre for Environmental Omics (JCEO): Professor John Colbourne J.K.Colbourne@bham.ac.uk MRC-funded Phenome Centre Birmingham: Dr Scott Harrison HarrisoS@adf.bham.ac.uk NERC Biomolecular Analysis Facility – Birmingham: Dr Ulf Sommer U.Sommer@bham.ac.uk Birmingham Metabolomics Training Centre: Dr Cate Winder C.L.Winder@bham.ac.uk Telephone Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · ·

+44-121-414-3344 www.birmingham.ac.uk

L

23 2009 OMICS research (genomics, transcriptomics, metabolomics) Areas of Activity · Research Service & Training External · Key partners include: Collaborations | BGI-Shenzhen | China National Genebank | Beckman Coulter | Thermo Scientific | The international Consortium for Environmental Omics and Toxicology

Member of

European Biotechnology NET WORK

An overview of the University of Birmingham The University of Birmingham has been challenging and developing great minds for more than a century. Characterised by a tradition of innovation, research at the University has broken new ground, pushed forward the boundaries of knowledge and made an impact on people’s lives.

We continue this tradition today and have ambitions for a future that will embed our work and recognition of the Birmingham name on the international stage.

Universities are never complete. They develop as new challenges and opportunities occur. At Birmingham we innovate, we push the frontiers of understanding; we ask new research questions, we turn theory through experiment into practice – because that’s what great universities do.

The Joint Centre for Environmental Omics (JCEO) is a partnership between the University of Birmingham, the China National GeneBank, and BGI (the first citizenmanaged, non-profit research institution in China). The JCEO is staffed and equipped to conduct uniquely challenging and large-scale molecular research projects that transform biology, and improve environment and health protection. The Joint Centre specialises in environmental genomics and biodiversity research, in molecular high-throughput toxicity testing, studies of natural populations, DNA meta-barcoding, and molecular screening to discover the function of genes and their regulation in response to environmental conditions. Together with Birmingham metabolomics facilities (below) the JCEO breaks new ground in multiomics research. Its main objective is to facilitate collaborative research projects among academic, government and industry scientists.

The Phenome Centre-Birmingham (PC-B) is part of a UK Stratified Medicine initiative led by the Medical Research Council (MRC) to develop analytical capacity and capability to enhance the fundamental research into the molecular basis of the changes that occur during disease and aging. The PC-B conducts metabolic phenotyping (metabolomics) studies across the breadth of the MRC

University of Birmingham

remit. It provides a collaboration project environment for performing metabolomics analyses in health studies and for academic projects is run on a cost recovery basis.

The Centre is staffed by experts in experimental design, analytical chemistry, bioinformatics and statistics to provide all required aspects of the study from conception to helping with biological interpretation.

NBAF-Birmingham (NBAF-B) is one of the nodes of the NERC Biomolecular Analysis Facility (http://nbaf.nerc. ac.uk/). NBAF-B was established in 2009 to serve the metabolomics research needs of the UK environmental sciences community (http://nbaf.nerc.ac.uk/applyingto-the-facility/). We are embedded in a well-equipped and vigorous research environment at the University of Birmingham that, together with continuing developments in equipment and training, ensures we maintain a ‘state-of-the-art’ position. We support metabolomic analyses using both high-resolution mass spectrometry and NMR methods and a variety of statistical approaches. We provide training courses in collaboration with the Birmingham Metabolomics Training Centre.

The Birmingham Metabolomics Training Centre (BMTC) provides training to empower the next generation of metabolomics researchers, by delivering training in both analytical and computational methods. The BMTC partners with both the Phenome Centre – Birmingham and NERC Biomolecular Analysis Facility – Birmingham to provide vocational training in clinical and environmental metabolomics. A combination of face-to-face and online courses are provided. The face-to-face courses include lectures, laboratory practicals and computer workshops, with significant hands-on training utilising state-of-the-art analytical instruments and software. The online courses are available to a wide audience and offer flexibility in time and study on a social learning platform.

7 th european biotechnology guide 2017

158 | 159

Name · University of Copenhagen Department of Drug Design and Pharmacology Address/P.O. Box · Faculty of Health and Medical Sciences, University of Copenhagen Universitetsparken 2 Postal Code/City · 2100 Copenhagen Country · Denmark Contact Person · Fredrik Björkling (Prof.)

Ole Thastrup (Prof. Head of Dept.)

Telephone · +45-35-33-60-00 Email · fb@sund.ku.dk, ot@sund.ku.dk Website · http://drug.ku.dk/ Social Media · F Number of Employees · 295 Type of Laboratory · Pharmaceutical research Areas of Activity · | Drug research | Drug design | Medicinal chemistry | Molecular biology | Natural product chemistry | Biostructural chemistry | Molecular, cellular and systems pharmacology | Pharmacotherapy External · Extensive external collaborations with Collaborations pharma and biotech, more than 150 ongoing externally financed research projects Request for · Yes Further Collaborations

Member of

European Biotechnology NET WORK

From chemistry to clinic We focus on the discovery, design, and development of potential new drugs and the detailed understanding of their pharmacological effects. As part of Denmark’s largest institution of research and education, we play a key role in training the pharmacists and drug design experts of the future via research-based teaching.

Our extensive research portfolio aims at tackling major global health challenges through the development of innovative, effective therapeutics along with the underlying research methods and technologies. Our seven main research sections are: ·· Natural Products and Peptides specialises in drug design inspired by natural products, including peptides targeting e.g. infections and cancer. ·· Medicinal Chemistry Research designs, synthesises, and investigates compounds that target receptors, transporters, enzymes, and signalling proteins involved in human disease. ·· Biostructural Research determines three-dimensional structures and structure-function relationships of compounds interacting with potential human drug targets. ·· Molecular and Cellular Pharmacology studies biological systems, particularly those regulating brain function and implicated in neurological disorders. ·· Experimental Pharmacology focuses on pharmacology of receptor and transporter targets, with work spanning from molecular pharmacology to in vivo testing in animals and human clinical trials. ·· Pharmacotherapy studies factors that influence patients’ individual responses to drug substances, seeking to optimise the treatment and safety for each patient. ·· The Centre for Biopharmaceuticals uses cutting-edge chemical biology approaches to create peptides and proteins with novel properties in order to develop advanced protein-based drug candidates.

Our state-of-the-art infrastructure enables world-class research, which external researchers can access via a collaborative or fee-for-service basis arrangement.

Core facilities include:

University of Copenhagen

·· Equipment for the study of protein-protein interactions in the context of drug design; an X-ray small angle scattering (SAXS) instrument is available. ·· Advanced NMR equipment in the associated Copenhagen Small-Molecule NMR Centre. ·· An in vivo platform for optical imaging and studies in behavioural pharmacology, pharmacokinetics, and pharmacodynamics.

Partnering for impact. Our breadth of drug-related disciplines provides a unique vehicle to work closely with the pharmaceutical and biotech industries as well as clinical hospital departments. We have more than 150 ongoing, externally financed research projects.

Innovation strategies aimed at generating novel therapeutics or diagnostics are integral to our research, resulting in several licenses and spin-off activities. We welcome new commercial, academic, and clinical partners with shared interests and complementary skills.

Selected research themes Biostructure in brain diseases. “Complex Structural Aspects of Signalling, Inflammation and Disease in the Brain”, is a topic addressed in the collaborative Danish biostructural research programme BRAINSTRUC, with the aim of understanding basic aspects of the brain’s function, eventually providing new treatment options in brain disease.

Development of new in vivo imaging agents. Based on a track-record of developing PET ligands from bench to bedside we are pursuing new imaging agents towards a number of CNS and cancer targets. Through an integrated medicinal chemistry and radiolabeling approach, we are advancing potential new PET tracers and developing new technologies for PET labelling.

Molecular mechanisms involved in drug resistance. One of the main obstacles to successful cancer treatment is the development of resistance to drugs. Similarly, a major threat is the currently evolving drug resistance to antibiotics. In this context, we are exploring mechanisms of resistance, aiming for increased understanding and discovery of improved treatments for these diseases.

7 th european biotechnology guide 2017

160 | 161

Name · University of Oxford

Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Website Number of Employees

· · · · · · · ·

University Offices, Wellington Square, OX1 2JD, Oxford United Kingdom Dr Murray Gardner +44-7725 221113 murray.gardner@mpls.ox.ac.uk www.ox.ac.uk >13,000 staff with over 5,700 graduate research students >22,000 students Founded (year) · 1096 Type of Laboratory · | Chemistry | Biochemistry | Plants | Medicine Areas of Activity · | Synthesis | Antibiotics | Structural biology | Imaging | Proteomics | Oncology | Catalysis | Epigenetics | Mathematics | Material science | Cell science | Agrochemicals | Plant science | Engineering | Bio-energy | Systems science | Computational biology

Annual Turnover · 2015–2016 total University income was £1321.6m Request for · We are particularly interested in parFurther Collaborations ticipating in large scale collaborations involving interdisciplinary science such as at the chemistry-biologymedicine interface.

Member of

European Biotechnology NET WORK

The University of Oxford is a complex and stimulating organisation, which enjoys an international reputation as a world-class centre of excellence in research and teaching. It employs more than 13,000 staff and has a student population of over 22,000.

Oxford is ranked first in the world in the Times Higher Education (THE) World University Rankings 2016–2017.

In the THE subject rankings 2016–2017, Oxford is, for the sixth year running, ranked first in the world for Clinical, Pre-Clinical and Health subjects. It is also ranked third in the world and first in the UK for Computer Science, and Engineering and Technology; third in the world for Life Sciences; and sixth in the world and second in the UK for Physical Sciences. Locally, the 2014 Research Excellence Framework, the official UK wide assessment of all university research, rated Oxford as having the largest volume of world-leading research in the country.

Oxford’s research activity involves more than 70 departments, 38 colleges, more than 1,800 academic staff, over 5,300 research and research support staff and over 5,700 graduate research students. Our academic staff come from almost 100 different countries and territories, with 41% being citizens of foreign countries. Similarly, 41% of our total student body – over 9,200 students – are citizens of foreign countries, including 19% of undergraduates and 63% of graduate students.

Our academic community includes 80 Fellows of the Royal Society and 100 Fellows of the British Academy, as well as Fellows of the Royal Academy of Engineering, the Academy of Medical Sciences, the Academy of Social Sciences, and many international learned societies.

52 Nobel prizes have been won by alumni and academics of the University of Oxford.

University of oxford

Oxford consistently has the highest research income from external sponsors of any UK university. External research grants and contracts continue to be the University’s largest source of income. In 2015–2016, 41% (£537.4m) of income came from external research sponsors.

Having pioneered the successful commercial exploitation of academic research and invention, our wholly owned research commercialisation company, Oxford University Innovation Limited (OUI), now has an annual revenue of nearly £22m. OUI receives over 400 invention disclosures and files around 100 new patents each year.

As a result, OUI manages a diverse portfolio of more than 2800 international patents and works to transfer this IP to industry for further investment and development. OUI executes around 100 technology licence deals per year, and in 2016 created more spin out companies than any other university technology transfer office in Europe. OUI’s Consultancy Services team manage more than 480 consulting projects per year.

One of the key drivers of innovative and entrepreneurial activity around Oxford has been the launch of Oxford Sciences Innovation (OSI). Oxford Sciences Innovation (OSI) provides capital and scaling expertise to new and existing spinout companies from Oxford. With £580m to invest in these spin-outs, OSI is the largest investment vehicle of its kind in the world.

The county of Oxfordshire is one of Europe’s leading centres of enterprise, innovation and knowledge. The county’s growth rate in high-tech employment remains one of the highest in the UK and many of its 1,500 hightech companies have links to Oxford University.

7 th european biotechnology guide 2017

162 | 163

Name · VAXIMM AG

Address/P.O. Box · Technologiepark Basel Hochbergerstrasse 60c Postal Code/City · 4057 Basel Country · Switzerland Contact Person · Dr Matthias Schroff, CEO Dr Heinz Lubenau, COO Telephone · +49-621-8359687-0 Email Address · info@vaximm.com Internet Website · www.vaximm.com Number of Employees · 10 Founded (year) · 2008 Type of Laboratory · R&D Areas of Activity · Drug development in oncology Oral T-cell immunotherapies External · Works with leading academic Collaborations institutions in its development activities, e.g. National Center for Tumor Diseases Heidelberg (NCT) Request for · New development partnerships and Further Collaborations collaborations with both industry and academia for the proprietary oral T-cell activation therapy platform and product candidates are welcomed

VAXIMM AG is a privately held, clinical stage, Swiss/ German biotech company developing oral T-cell immunotherapies for patients suffering from cancer.

VAXIMM is headquartered in Basel, Switzerland with a wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, from where the Company’s development activities are run.

Technology VAXIMM’s technology is based on first-in-class oral T-cell activators that can be readily adapted to target a wide range of cancer-related antigens. The platform is based on the live attenuated bacterial vaccine strain Ty21, which has been administered to millions of people as a prophylactic vaccine to temporarily protect them from typhoid fever. This strain has been proven to be very safe and well tolerated. All immunotherapies resulting from this platform are taken orally by the patient.

After oral ingestion, the modified Ty21a bacteria, which contain the cDNA of the desired cancer target(s), pass the stomach and invade the patient’s Peyer’s patches located in the small intestine. Uptake of the bacteria in macrophages, the eating cells present in these lymphoid tissues, leads to strong expression of and subsequently to a specific cellular immune response towards the encoded cancer antigen(s). These so-called “killer” T-cells then destroy the respective antigen expressing tumor or tumor stroma cells.

The oral bacterial technology enables delivery to the most immunocompetent organ of the body, targeting the lymphatic tissue of the gut, and has been shown to generate robust T-cell responses against many different antigens in animals and humans in first clinical studies.

The low therapeutic doses required for specific T-cell activation make this approach suitable for continuous dosing (prime & boost administrations) without raising anti-carrier immunity and provide another safety margin for carrier-related toxicity.

vaximM

The platform is suitable for addressing multiple targets with one treatment and can be combined with additional immune therapies. Other major advantages of this approach include the high modularity (plug and play), the low cost and robustness of the production process, and the rapid development timelines to take products from concept to clinic.

Product pipeline

Mode of Action Intra-lymphatic Delivery via Oral Administration

The Companyâ&#x20AC;&#x2122;s lead product candidate, oral VXM01, targets VEGFR2. A Phase I/II trial in advanced pancreatic cancer showed that VXM01 was safe, well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Two further clinical Phase IIa trials, one in metastatic colorectal cancer and one in recurrent glioblastoma, are currently ongoing. VAXIMM is planning a clinical trial to evaluate VXM01 in combination with a checkpoint inhibitor. Preclinical data support that adding VXM01 to treatment with a checkpoint inhibitor may increase survival.

VAXIMM has several additional product candidates at various stages of preclinical development. These candidates can be developed as stand-alone therapies or in combination with other immunotherapies, including VXM01. In addition, VAXIMM is using its platform technology to develop a personal neoantigen approach. VXM NEO has demonstrated immune proof of concept.

7 th european biotechnology guide 2017

164 | 165

Name · Xell AG

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Social Media Number of Employees Founded (year) Type of Laboratory

· · · · · · · · · · · ·

Alte Verler Str. 1 33689 Bielefeld Germany Dr Tim Beckmann +49-521-96989-200 +49-521-96989-201 info@xell.ag www.xell.ag

IQ

> 20 2009 Analytical and cell culture laboratory (S1) Areas of Activity · Biopharmaceutical solutions, processes and services with a focus on cell culture media and feeds External · Global network of pharma and Collaborations biotech companies as well as research institutes

Request for · l Contract development of cell culture Further Collaborations media and feeds l R&D collaborations and strategic partnerships

Company profile Xell is an innovative and agile partner for the biotech and pharmaceutical industry, providing highly efficient solutions in cell culture technology. Since our formation, we have had a dedicated focus on cell culture medium development and have continuously strengthened our proprietary technology. A broad range of successful projects throughout different applications in biopharmaceutical production has helped us to gain a reputation as a reliable partner for the biotech industry. We have been working with recognised pharma companies, CMOs, as well as SMEs and research institutes, to improve their process efficiency, yields, and quality in biopharmaceutical production.

Customised medium development As a leading company for cell culture medium and feed development, Xell offers targeted, efficient, and rapid services for the development and optimisation of culture media for customer cell lines. We utilise our proprietary approach based on metabolic models, powerful analytical tools, and a superior platform media technology to rationally design tailored solutions for our clients.

Ready-to-use products Besides customised formulations, Xell offers highperformance off-the-shelf media products and special application solutions. These media and feeds are available both as liquid formulations as well as powdered products for large scale manufacturing with certified quality.

Production media and feeds: ·· CHO ·· HEK / human ·· BHK, MDBK, MDCK ·· Hybridoma Media for transient gene expression: ·· CHO ·· HEK / human

Xell

Additional services Intensive work in the field of mammalian cell culture makes us an excellent partner to provide additional services and face our customers’ analytical and process-related challenges. From spent media to product analyses, Xell offers a complete range of analytical tools.

Other services include cell studies, process development, media lot testing, and media stability studies.

With a highly capable team of scientists, we generate comprehensive data sets for our customers’ cultures or samples, enabling them to better understand complex cell behavior and processes.

Quality statement Chemically defined and free of animal components, Xell’s culture media meet all necessary quality standards required by the regulatory authorities for GMP manufacturing. Our contract services provide reliable results with versatile experts, ensuring a successful transfer to the customer.

At a glance ·· Rational cell culture medium development ·· Off-the-shelf media and feed products for research and further manufacturing use ·· Reliable analytical services ·· Versatile process services ·· Efficient and flexible workflows ·· Dedicated and personal spirit

People ·· ·· ·· ·· ··

Stefan Northoff (CEO) Christoph Heinrich (COO) Prof. Dr Thomas Noll (Chairman Supervisory Board) Dr Sandra Klausing (Director Scientific Innovations) Dr Tim Beckmann (Director Strategic Development)

7 th european biotechnology guide 2017

166 | 167

Š Rawpixel/Fotolia.com

Join the European Biotechnology Network!

The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. This non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships.

Do you want to know more about the advantages of a (free) membership? Just have a look at our website.

European Biotechnology European Biotechnology Network AISBL Rue de la Science 14b | 1040 Brussels, Belgium Tel: +32 (0)2 733 72 37 office@european-biotechnology.net

www.european-biotechnology.net

C O R P O R AT E M E M B E R S 1/17

NET WORK

VOLUME 7

2017

7th European Biotechnology Guide

European Biotechnology Guide Science & Industry

ISBN 978-3-928383-62-2

European Biotechnology NET WORK