VOLUME 8
2018
8th European Biotechnology Guide
European Biotechnology Guide Science & Industry
ISBN 978-3-928383-66-0
European Biotechnology NET WORK
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European Biotechnology Guide Science & Industry
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© BIOCOM AG, Berlin 2018 European Biotechnology Science & Industry Guide 2018 (Volume 8) Published by:
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Editorial
We live a success stor y, but never forget the big picture Here it is, the 8th edition of the European Biotechnology Science & Industry Guide, showcasing brilliant science and excellent business from companies, universities, research institutes, and expert support providers. The European Biotechnology Network, which is celebrating its tenth anniversary this year, is proud to present this useful and colourful book again. How does Europe feel this year? This depends on which country you live in. In general, the economy is doing well, although unemployment is still high in many places. The debt crisis, the refugee situation and the Brexit continue to simmer. In some countries populists set the tone with nationalist slogans: They insult the European institutions, but they are keen to take their money. Many national governments also deal with backward-looking issues. The generation change in leadership, which has already been achieved in France and Austria, for example, is still missing in many countries and is becoming increasingly urgent. Globalisation, climate change, sustainability, digitalisation, health, freedom – these should be the big issues everywhere. It is good that European cooperation in research & development is so smooth and harmonious. For biotechnologists, the united Europe has long been a matter of course. That’s good! But when Britain leaves the Union, there will be a major test of pressure, not only financially. The other major factor in the further successful development of the life sciences sector is that the technological story is simply excellent and intact. Each new discovery in molecular biology brings us a step further in the understanding of life. This is the prerequisite for making our economy healthier, more sustainable and more competitive. In comparison, the currently hyped Artificial Intelligence is a storm in the water glass. Read for yourself what’s new in this interesting and comprehensive book. And let’s work together to make this planet a better place. Over-egged the pudding? Well, at least every now and then we should allow ourselves to think about the big picture. Brussels, February 2018 Andreas Mietzsch European Biotechnology Network www.european-biotechnology.net 8 th european biotechnology guide 2018
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Content
Editorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
JPT Peptide Technologies GmbH. . . . . . . . . .
. . . . 90
Analysis of European biotech companies on the stock markets.. . . .
7
Labor Dr. Merk & Kollegen GmbH. . . . . . . . . . Leitat – Technological Center . . . . . . . . . . . . . Lipotype GmbH. . . . . . . . . . . . . . . . . . . . . . . .
. . . . 92 . . . . 94 . . . . 96
Medicines for Europe. . . . . . . . . . . . . . . . . . . Microsaic Systems plc. . . . . . . . . . . . . . . . . . Microsynth AG. . . . . . . . . . . . . . . . . . . . . . . . . MOLOGEN AG . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 98 . . . . 100 . . . . 102 . . . . 104
Novaliq GmbH. . . . . . . . . . . . . . . . . . . . . . . . . NSF Health Sciences Ltd.. . . . . . . . . . . . . . . .
. . . . 106 . . . . 108
OPIS Group. . . . . . . . . . . . . . . . . . . . . . . . . . . Orion Oyj. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 110 . . . . 112
Pierre Guérin SAS. . . . . . . . . . . . . . . . . . . . . . Polpharma Biologics. . . . . . . . . . . . . . . . . . . . ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . . PROGEN Biotechnik GmbH . . . . . . . . . . . . . . ProQinase GmbH . . . . . . . . . . . . . . . . . . . . . . Protavio Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 114 . . . . 116 . . . . 118 . . . . 120 . . . . 122 . . . . 124
Recipharm. . . . . . . . . . . . . . . . . . . . . . . . . . . . Redx Pharma Ltd. . . . . . . . . . . . . . . . . . . . . . . Rentschler Biopharma SE. . . . . . . . . . . . . . . . Richter-Helm BioLogics GmbH & Co. KG. . . . Roto Inox d.o.o.. . . . . . . . . . . . . . . . . . . . . . . . RTC S.p.A.. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 126 . . . . 128 . . . . 130 . . . . 132 . . . . 134 . . . . 136
Sartorius Stedim Biotech GmbH. . . . . . . . . . . SOCOREX ISBA SA. . . . . . . . . . . . . . . . . . . . . Swiss Biotech Association SBA . . . . . . . . . . .
. . . . 138 . . . . 140 . . . . 142
Trockle Business Consultancy. . . . . . . . . . . . .
. . . . 144
UBM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . University of Birmingham . . . . . . . . . . . . . . . .
. . . . 146 . . . . 148
VAXIMM AG. . . . . . . . . . . . . . . . . . . . . . . . . . . VIVEbiotech S.L.. . . . . . . . . . . . . . . . . . . . . . .
. . . . 150 . . . . 152
Wood – Amec Foster Wheeler. . . . . . . . . . . . .
. . . . 154
Xell AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 156
YUMAB GmbH . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 158
Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 . . . . 16 3P Biopharmaceuticals S.L. . . . . . . . . . . . . . . Aglaris Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . . . AIT Austrian Institute of Technology GmbH. . . ASEBIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Axolabs GmbH . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . .
18 20 22 24
BaselArea.swiss . . . . . . . . . . . . . . . . . . . . . . . Biaffin GmbH & Co KG . . . . . . . . . . . . . . . . . . BIOCOM AG . . . . . . . . . . . . . . . . . . . . . . . . . . BioMediTech. . . . . . . . . . . . . . . . . . . . . . . . . . Boehringer Ingelheim . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . .
26 28 30 32 34
Campania Bioscience Scarl. . . . . . . . . . . . . . CEBIS International SAGL. . . . . . . . . . . . . . . . CEVEC Pharmaceuticals GmbH. . . . . . . . . . . Charles River. . . . . . . . . . . . . . . . . . . . . . . . . . Choose New Jersey, Inc.. . . . . . . . . . . . . . . . . co.don AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . Coriolis Pharma Research GmbH. . . . . . . . . . CureVac AG. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
36 38 40 42 44 46 48 50
Enzymicals AG. . . . . . . . . . . . . . . . . . . . . . . . Eurofins BioPharma Product Testing Munich. . EuropaBio. . . . . . . . . . . . . . . . . . . . . . . . . . . . Evotec AG. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . .
52 54 56 58
FGK Clinical Research GmbH. . . . . . . . . . . . . FILTROX Group. . . . . . . . . . . . . . . . . . . . . . . . Fördergesellschaft IZB . . . . . . . . . . . . . . . . . . Fraunhofer ITEM. . . . . . . . . . . . . . . . . . . . . . . Fundación MEDINA. . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . .
60 62 64 66 68
Genevia Technologies Oy . . . . . . . . . . . . . . . .
. . . . 70
Heidelberg Pharma AG. . . . . . . . . . . . . . . . . . Holochem SAS . . . . . . . . . . . . . . . . . . . . . . . . Holodiag . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 72 . . . . 74 . . . . 76
IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . . Infrapark Baselland AG. . . . . . . . . . . . . . . . . . intravacc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . IRBM Science Park SpA. . . . . . . . . . . . . . . . . ITM Isotopen Technologien München AG. . . .
. . . . . . . . . . . . . . . . . . . . . . . .
78 80 82 84 86 88
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Analysis of European biotech companies on the stock markets: US vs Europe Executive summary After a healthy reset in 2016, biotech stock markets experienced a new wave of optimism with increased volumes of IPOs and financings in 2017. Investors’ appetite was revived on the US Nasdaq in particular. This report highlights the key facts. Compared to the more cautious situation in 2016, the European public biotech sector is on the road to further growth this year. In 2017, the volumes of IPOs and followon financings increased compared to the preceding year. This is demonstrated by the final numbers for 2017, brought together in this issue of BIOCOM’s capital market report. The report analyses all of the European biotech firms listed on one of the 14 trading centres in Europe or on the US Nasdaq. Taking all indicators into account – number and volumes of IPOs, follow-on financings and secondary listings – total proceeds of €5.17bn were raised by European biotech firms in 2017, an increase of 56% compared to 2016. In 2017, a total of 20 European biotech IPOs took place, raising a total amount of €866m. This year shows an increase of 56% compared to 2016. Most of the 20 firms opted for one of the 14 European trading centres, with five companies floating on US Nasdaq, instead. The highest IPO volumes in 2017 were recorded for ObsEva SA (€90m),
Key facts of European and US public biotech sector Europe Number of public biotech companies Market capitalisation* Turnover (2016) Capital raised via IPOs Numer of IPOs
InflaRx (€86m) and Nucana Biomed (€85m) on the US Nasdaq. Additionally, five secondary listings of European companies on Nasdaq were recorded to date: argenx (€103m), Verona Pharma (€82m), Zealand Pharmaceuticals (€67m), ERYtech (€106.5m) and Ablynx (€195m). Revival on the US Nasdaq In 2017, US investors showed significant interest in biotech stocks compared to the preceding year European biotech companies profited from this positive trend. They raised total financial proceeds of €2.21bn via IPOs, secondary listings and follow-on financings in the US, representing almost half (43%) of the total capital raised by all European biotech companies in 2017. Europe more attractive in 2017 In 2017, the majority of companies decided on a listing in Europe (15) in comparison to the US (5). Among the European trading centres, Paris and London, in particular, are the most attractive stock markets. In addition, the stock market in Stockholm seems to appeal to more and more biotech companies.
New wave of optimism Following a more cautious year 2016, the European public biotech sector observed an new increase of IPO and follow-on financing volumes in 2017. Riding on the wave of this development, new found confidence is growing.
US
234
3311/2
€ 155.05 bn
–
€ 16.07 bn
–
€ 866m
€ 2.03 bn1/2
20
251/2
Source: 1 US companies on Nasdaq US; 2 BIOCOM research based on data provided by investships.com; *Market cap on 4 Oct 2017 © BIOCOM AG
After record financings for European biotech companies on the stock market in 2015 and significantly lower activity in 2016, there is currently a growing optimism that sees stock markets as a viable route for biotech companies to access further capital. According to the analysis, which also includes all European biotech firms listed on the US Nasdaq, all of the key figures for 2017 show new signs of confidence. The 234 European biotech companies raised a total of €5.17bn of financial proceeds until the end of 2017 – 56% more than in the same period of time in 2016 (€3.30bn). 8 th european biotechnology guide 2018
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Currently, the most attractive stock market locations are Paris (47) and London (44). However, the number of listed biotech companies in Sweden has also increased by up to 41. The shares of 36 European companies are currently traded on US Nasdaq and the most recent US IPO was conducted by German InflaRx (€86m).
Total financial proceedings of European biotech companies €6.29bn €5.17bn
€3.30bn –48%
2015
2016
© BIOCOM AG
+56%
2017
IPO window open In 2017, a total of 20 European biotech IPOs took place, raising a total figure of €866m. This year shows an increase of 56% on the same period in 2016. The majority of 15 firms opted for one of the 14 European trading centres, with five firms floating on US Nasdaq, instead. Compared to the previous year, investor appetite was higher and the sums larger. The greatest IPO volumes in 2017 were recorded for ObsEva (€90m), InflaRx (€85m) and Nucana Biomed (€86m) on the US Nasdaq.
Follow-on financings In 2017, investors are showing increased enthusiasm for European biotech companies compared to 2016. Until the end of 2017 a total of €4.3bn was dropped into these companies via follow-on financings, a substantial increase of 57% compared to the same period in 2016. The average size of capital increase in 2017 almost doubled to €35m, compared to €19m in the same period of 2016. Much of the increase is due to the fact, that the climate on Nasdaq ameliorated significantly whereas on the European trading centres almost the same money was raised with less follow-on financings taking place in 2017 (123) compared to 2016 (144). Within Europe, Euronext demonstrated the most activity with 33 financings and total proceeds of €1.4bn, followed by Frankfurt (23 financings, €312m) and AIM (16 financings, €231m). A significant increase was observed in the US where a total of €1.83bn came in through Nasdaq. This was almost ten times as much as in 2016 (€190m).
Distribution of market capitalisation of European biotech companies* Large cap
2.2% (5)
Mid cap
5.3% (12)
Small cap
21.9% (52)
Micro cap
39.9% (91)
Nano cap
30.7% (70)
0
10
*Market cap on 4 Oct 2017
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20
30
40
50
60
70
80
90
100 © BIOCOM AG
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Market cap
Fields of activity Health/medicine (200 companies) Industrial biotechnology (20 companies) Agribiotechnology (1 company) Non-specific services (13 companies) 0.4 % 5.6 % 8.5%
Compared to last year’s analysis, investors demonstrated improved interest in the companies in Europe and for this reason, they observed a slight increase in their overall market cap (2016: €106bn).
85.5%
Oncology in the spotlight The dominance of nano and micro cap companies in Europe also explain the comparatively low turnover. In 2016, European biotech firms generated a combined total turnover of €16.07bn (2015: €14.02bn). The vast majority of companies (85%) are active in the health sector, developing diagnostics or new therapies for which major investments and long-term financial strategies are
© BIOCOM AG
The European public biotech sector continues to mature. At the beginning of October 2017, the European biotech companies had a joint market capitalisation of €155bn. About 40% of the European biotech companies operate in the “micro” range between US-$50m and US-$300m. A further 31% ranks among nano caps (below US-$50m). Therefore, 71% of all companies have a market cap of less than US-$300m. A total 17 companies have caps exceeding US-$2bn, these include the firms Actelion, Novozymes, Qiagen, Genmab and Eurofins.
required. Almost all of the 20 stock market newcomers in 2017 can be assigned to this category. The most attractive field within the health area is oncology. A total of
European biotech companies and the areas of indications* they address Autoimmune diseases
27
Cardiovascular diseases
16
Dermatology
6
Infections
23
Inflammatory diseases
31
Metabolic diseases
30
Neurology
36
Oncology
75
Respiratory diseases
12
Other
45 *Several mentions possible
© BIOCOM AG
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Number of IPOs and the capital raised Initial public offerings: 2017
Total proceedings
Average volumes
Total number €866m
€43m
20
+56%
2016
€556m
17
€33m
Number of financing rounds and the capital raised Follow-on and other financings: 2017
Total proceedings
Average volumes
Total number €4,300m
€35m
123
+57%
2016
€2,746m €19m
75 companies operate in this field, followed by neurology (36), inflammatory (31) and metabolic diseases (30) as well as autoimmune diseases (27). Service providers that offer biotech-based processes for others in the B2B environment have a completely different risk profile than companies focused on biopharma. Although mid- and large-cap companies such as bioMérieux and Eurofins fall into this category, only 13 companies overall operate in this field. Another area of listed European companies is industrial biotechnology. A total of 20 firms are involved in the development of new enzyme-based processes or biobased solutions for various industries. German bioeconomy pioneer Brain AG has been among the newcomers in this field in 2016. In 2017, Swedish SenzaGen, a specialist for immunotoxicological assays to predict and classify chemical sensitizers with a state-of-the-art predictive performance, went public in Stockholm.
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141
Stockholm catches up With 14 different trading centres, the variety of stock exchanges relevant for European biotech companies is huge. Analysis of previous years has 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 innovation and high-risk financing. In 2017, 5 IPOs took place here. However, Scandinavian city Stockholm has caught up with 6 new listings recorded this year, among them Oncopeptides AB, raising €68m, and BioArtic NeuroScience AB with €71.8m. Two British newcomers – Destiny Pharma and SkinBio Therapeutics – performed an IPO at the LSE. One listing each took place in Oslo (BerGenBio) and in Copenhagen (OrphaZyme). The 5 companies already listed, Zealand Pharmaceuticals (Nasdaq Nordic), argenx (Euronext), Verona Pharma (AIM), ERYtech Pharma (Euronext) and Ablynx (Euro-
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next), went public with a secondary offering on Nasdaq in New York. As forecast by analysts, the overall mood on the stock markets improved compared to the previous year. The number and volumes of IPOs as well as follow-on financings increased, in particular due to an upward trend on Nasdaq. It seems, that IPOs and stock market listings are increasingly establishing themselves as one of financing options to strengthen future business growth in the European biotech sector.
Development of follow-on financings in €bn since 2012
651
total number
US market revival Biotech stocks in the US have recovered significantly in 2017. It corresponds with a number of successful initial public offerings, secondary listings and substantial follow-on financings by European biotech companies. The global public market surge in 2014 was followed by an all-time high for biotech companies on the US stock markets and European biotech firms showed huge interest in opting for a US listing. However, in 2015 the situation started to change and the biotech IPO boom began to cool off. In 2016, matters deteriorated even further. Now, in 2017, the situation has finally improved as the US stock market offers a far greater number of biotech investors than their European counterparts. For this reason, European biotech companies haven’t lost their interest in IPOs and secondary listings abroad. In total, 36 Euro-
2012
1.23
2013
1.91
2014
2.21
2015
5.08
2016
2.75
2017
4.30
€17.48 billion
Overview of trading centres with total numbers of European biotech companies 8
6
3
2
*Euronext, **Nasdaq Nordic
helsinki **
1
Milan
2017
brussels *
Zurich
Frankfurt
6
amsterdam *
1
7
Warsaw
new york
9
Madrid
Stockholm ** 2017
9
copenhagen **
2017
11
oslo
5
17
2017
6
london
24
2
5
234
41
2017
44
paris *
47
© BIOCOM
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Comparison of capital raised via IPOs in €m and number of IPOs
2017
374.8
2016
164.6
2015
2012
5 14
391.3
3 806.2
406.6
2014 2013
15
490.7
21 4
506.9
740.0
16 9 5
59.4 47.0
1 5
110.1 94.0 European exchanges
1 NASDAQ
pean biotech companies were listed on Nasdaq by the end of 2017.
Investors’ appetite returns In 2017, investors showed significant interest in biotech stocks compared to 2016. European biotech companies profited from this trend. They raised total financial proceeds of €2.16bn via IPOs, secondary listings and followon financings on the US Nasdaq. This is nearly half (42%) of the total capital raised by all European biotech companies in 2017 and highlights the power of biotech-focused investors available through Nasdaq.
US boasts greater IPO volumes In 2017, 5 European biotech companies raised a total of €375m via IPOs on the US Nasdaq, which is twice as much (+228%) compared to 2016 (€165m) and includes Swiss company ObsEva (€90m), German InflarX (€85.8m), Austrian Arsanis Biosciences (€50.8m), UK-based Nightstar Therapeutics (€63.5m) and Nucana Biomed (€84.7m). In the US, average IPO volumes are higher than those on European stock exchanges. In 2017, the US stock exchange average amounted to €75m, compared to only €33m on European exchanges. The Nasdaq proceedings, however, didn’t top past IPO levels, such as those of UKbased Adaptimmune (€170m) in 2016 or Forward Pharma (€186m) from Denmark in 2014.
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© BIOCOM AG
Follow-on financings US investors’ appetite was revived in 2017 following a decline in 2016. The 36 listed companies attracted a combined total of €1.83bn in follow-on financings, including 5 secondary listings which alone amounted to a total capital of €553.3m. Compared to their counterparts which are listed on European stock exchanges only, the firms on the US Nasdaq generated significantly more capital this year and with greater average volumes (US: €83.4m vs. Europe: €42.4m).
Drug developers aim for US Nasdaq Drug developers, in particular, opt for a US listing, which is clearly associated with their high demands for capital. Newcomers to the Nasdaq in 2017 are active in the field of reproductive health (ObsEva), cancer therapeutics (Nucana), blinding eye diseases (Nightstar), infections (Arsanis) and inflammation (InflarX). The same applies for the secondary listings: respiratory diseases (Verona), metabolic diseases (Zealand) and cancer/autoimmune diseases (argenx, ERYtech, Ablynx).
Greater market capitalisation In 2017, 15% of the 234 listed companies traded their shares on the US Nasdaq. The companies have a combined market capitalisation of €32.19bn, which means an average of €975m. This is almost one third higher
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(₏630m) than the market cap of the firms listed in Europe only. The lion’s share of US-listed companies (48.5%) operate in the small-market capitalisation range between US-$300m and US-$2bn with a further 36.4% of the firms within a micro cap range between US-$50m and US$300m. Similar to their European-listed counterparts, only a few companies (15.2%) fit in the mid-market cap range between US-$2bn and US-$10bn. A big difference between both markets, however, is that in the US there are no companies in the nano-market cap below US$50m. This suggests that the US-listed companies have a slightly higher degree of maturity.
If you are interested to get the full version of the report for free, please visit: www.biocom.de/en/analysis2018 BIOCOM offers a broad spectrum of services to our clients from industry and the public sector: Customised consultancy services Surveys and market intelligence OECD data collections in biotechnology and life 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
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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.
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Profiles
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Name · 3P Biopharmaceuticals Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Telephone Email Website Number of Employees Founded (year)
· · · · ·
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
Areas of Activity · | Biotechnology | Biomedicine
Company profile 3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organisation (CDMO) specialized in the process development and GMP manufacturing of biopharmaceutical and cell therapy products. People, passion, and precision 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 to bring their candidates from the early stages of development up to clinical phases and, ultimately, to commercialisation. In its state-of-theart biomanufacturing facilities, the company also offers a comprehensive range of analytical and development services as well as continuous regulatory support that improves the value of its client’s candidates.
GMP certified 3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained both mammalian and microbial expression systems. 3P is GMP certified by AEMPS* for: ·· API manufacturing (clinical trials & commercial phase) ·· QC and release of API and final products for clinical trials and commercial phases * Spanish Medicines and Sanitary Products Agency (equivalent to EMA)
Summary services Biologics (new biological entities / biosimilar) development of bioprocesses and GMP manufacturing of: ·· Recombinant proteins ·· Vaccines ·· mAbs ·· ADCs ·· Fabs Advanced therapies (cell therapy) for non-GMP/GMP processes ·· Cell therapy products ·· Tissue engineered products ·· Cell culture media ·· Biomaterials (scaffolds or membranes)
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3P Biopharmaceuticals
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, characterisation 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 10 L, 100 L, and 1,000 L, as well as a mammalian cell culture system fully segregated with a current capacity of 50 L 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. In addition to the fit-out areas, 3P has sufficient shell space available for expansion and adaptation to new projects. The facility also contains a cell therapy area and a research and development area for process development and quality control laboratories.
Track record 3P has been involved in GMP manufacturing projects starting from gene design up to commercial manufacturing involving Technology Transfers from several CMO s based in Europe, United States, Argentina and Australia and targeting late stage GMP manufacturing. 3P has experience working with different expression systems: microbial (E. Coli, S. Cerevisiae, H. Polymorpha, P. Pastoris) and mammalian (CHO , BHK, HE K, Hybridomas) for the process development and GMP manufacturing of New Biological Entities (NBEs) like fusion proteins, vaccines, monoclonal antibodies among others. Moreover, the company has extensive experience in biosimilars (development from bacterial and mammalian processes; innovator characterization and comparability studies). 8 th european biotechnology guide 2018
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Name · Aglaris Ltd. Address/P.O. Box · Stevenage Bioscience Catalyst Gunnels Wood Road Postal Code/City · SG1 2FX Stevenage Country · United Kingdom Contact Person · David Horna Telephone · +44-1438906785 Email Address · aglaris@aglaris.co.uk Internet Website · www.aglaris.co.uk Number of Employees · 20 Founded (year) · 2012 Areas of Activity · l Cell manufacturing automation l Bioprocesses design l Cell processing technologies development
Executive summary Aglaris’s automated cell production system, Aglaris Facer 1.0, has the potential to revolutionise the world market for massive cell production; this system is designed for use in hospitals for cell therapy, biotechnology and pharmaceutical companies that use a large number of cells, and research centres. The Aglaris Facer 1.0 can grow a large number of cells in a completely automated process. This increases process efficiency by 10% and reduces cell production costs by 80%. Aglaris Facer 1.0 is designed to perform the entire cell culture process, as well as all of the necessary quality controls, to ensure cell growth within the strictest quality standards.
Introduction The demand for cell cultures is rapidly expanding. Every day more and more applications require a large number of cells as a starting point (for example cell therapy, tissue engineering, production and development of drugs). It is estimated that the market for cellular therapies will reach approximately £10bn in the next five years. To meet the needs that such processes require, a more affordable and reliable cell source will be needed. This can be achieved with the use of the Aglaris Facer 1.0 system.
Company history Aglaris Cell, S.L. was founded in February 2012 to develop a cell production system capable of solving the current problems in the cell culture process and to provide the market with tools that can meet the future demands of cell culture. The technologies used are Aglaris’s proprietary patents developed by the entrepreneurial team. In the strategic and scientific fields, Aglaris has collaborated closely with ISIS Innovation from the University of Oxford. An agreement with a major engineering centre has also been made to design and develop product components. To start its internationalisation process Aglaris Ltd. was set up in July 2014. Currently Aglaris has its headquarters in the Stevenage Bioscience Catalyst,
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AGL ARIS
Aglaris Facer 1.0 Bioreactor
where conducts all its bioengineering developments as well as a subsidiary company in Madrid (Spain) where it develops the biomaterials needed for the cell expansion.
Technological advancement The Aglaris Facer 1.0 technology is being fully developed at Aglaris. This technology allows the culture of cells from a biopsy to the maximum number of cells allowed by each cell type’s proliferation capacity without any human intervention. The patent for this technology has already been granted in the USA and China, and has been submitted to the EU and Canada, (WO 2013/186318). After each culture, the system delivers both the required number of cells for the user, and all the additional samples necessary for final lot inspection. The system has two types of components, fixed equipment that is reused, and a set of consumables that is discarded after each culture. The consumables are where the versatility of Aglaris Facer 1.0 is demonstrated. Depending on the characteristics of the interior surface of the consumable, Aglaris Facer 1.0 can be used for any type of cell expansion.
Cell culture bioreactor
Iterative method
Make it easy
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Name · AIT Austrian Institute of Technology 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
· · · · · · · · · · · ·
Giefinggasse 4 1210 Vienna Austria Dr Martin Jung +43-50550-4407 +43-50550-4450 m.jung@ait.ac.at www.ait.ac.at
FL I 1,300 2009 l Molecular biology laboratories l Chemistry laboratories l Physics laboratories l Clean room laboratories for thin film technologies
Areas of Activity · l Molecular diagnostics l Biomarker research and development l Biosensor development l Assay development l Bioinformatics l POC systems l Systems integration Annual turnover · €143m External · National and international clinics and Collaborations academia, e.g. l Imperial College London l Medical University Vienna l Medical University Graz l Medical University Hamburg National and international industry, e.g. l Boehringer Ingelheim l Biovendor l Scienion l Greiner BioOne l Oasis Diagnostics l R-Biopharm l Sandoz
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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 foci 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 known as tumour-associated antigens (TAAs), which can evoke an immune response, resulting in the production of autoantibodies. These autoantibodies can be detected months or years before the clinical diagnosis of cancer, thus, serving as biomarkers for early diagnosis.
Saliva as a diagnostic medium A main research area is saliva diagnostics. “As molecular methods have become increasingly sensitive, much information can nowadays be gained from saliva instead of blood analysis,” explains Dr Martin Jung, interim 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.
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austrian institute of technologe
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 optimize methods of classification/pattern recognition in terms of diagnostic applications of molecular biological data.
Point-of-care 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 among the individual components, while also providing a simple and userfriendly overall system.
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> 28-30 September, 2016 BILBAO, SPAIN
8th INTERNATIONAL MEETING ON BIOTECHNOLOGY
ROFILE
by Industry
............................................................... 51% ....................................................33% Name ...................................................... 7% ...................................................... 6% ...................................................... 5% s/Universities/Clusters ....................... 11% ............................................................... 10% Address/P.O. Box ..................................................................8% & consulting ...........................................8% Postal Code/City ..................................................................5% ..................................................................2% Country ing ............................................................3%
> 28-30 September, 2016
· ASEBIO – BILBAO, SPAIN Spanish Bioindustry Association
· · · Contact Person ·
Telephone Mobile Fax Email Website Number of Employees Founded (year)
· · · · · · ·
Diego de León, nº 44, 2º Dcha 28006 Madrid Spain Lucía Cecilia Communication manager +34-91-2109310-74 +34-663-117-293 +34-91-25000-63 > CONTACT: secretariageneral@asebio.com Sponsorship, Partnerships & Management www.asebio.com 12 dfernandez@asebio.com 1999 For additional information, please visit our website: www.biospain2016.org
Areas of Activity · ASEBIO is the Spanish Bioindustry Association, a private, non-profit organisation funded by memberships. ASEBIO brings together companies, associations, foundations, universities, and research and technology centres that carry out activities directly or indirectly related to biotechnology in Spain. ASEBIO, part of Europabio, currently has 285 partners.
> OU PLATINUM
Biospain 2018 brings you to the hub 8th INTERNATIONAL country of biotechnology in Europe MEETING ON
Biospain is the BIOTECHNOLOGY largest biotech event organizsed by a national bioindustry association in Europe and one of the largest in the world by the number of one-to-one meetings (+3,000) and companies participating (+800). 34% of our delegates come from outside of Spain. Biospain is organised by ASEBIO, the Spanish Bioindustry Association, and each edition is co-organised by a local institution from the host city/region. For the 2018 edition, Biospain is co-organised by the Government of Andalusia through the Agencia IDEA Agency. The Spanish Bioindustry Association (ASEBIO) comprises close to 300 members, representing 80% of the industry, both public and private. > www.biospain2016.org Its members include leading Spanish bioindustry companies, institutions, and service providers. ASEBIO works with national, regional, and European authorities interested in using biotechnology to improve living standards, employment, and environmental sustainability. It is a member of the European Association for Bioindustries (Europabio) and the Spanish Confederation of Employers Organisations (CEOE). From the 25th to the 27th of September 2018 the Fibes Exhibition & Congress Centre in Seville (Spain) will be the stage for Biospain, a forum for all the actors in the biotechnology sector to share knowledge, ideas, and experiences. Biospain is made up of a commercial fair, a partnering event, an investment forum, a training and employment forum, conferences on a range of issues (with parallel sessions) attended by national and international speakers, and a scientific conference organised by scientific societies. Among other topics for this year’s edition, the Biospain 2018 programme will feature the following thematic areas: bioinformatics, cell & molecular biology, circular economy, financing, food & nutrition, genomics & proteomics, marine biotechnology, nanotechnology, oncology, rare diseases, regenerative medicine, and vaccines.
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GOLD SPON
SILVER SPO
SUPPORTE
MEDIA PAR
ASEBIO
Biospain 2016, the 8th edition of this International Biotechnology Meeting, attracted investment groups with a greater investment capacity than at previous editions, investors who have also shown more interest in Spanish biotechnology projects. “Whereas previously we needed to make a bigger effort to get them to Biospain, this time they knew this was the place to be”, explained Jordi Martí, president of ASEBIO. A total of 46 investment funds attended the event, during which 30 Spanish entities presented business projects. The forum, organised in collaboration with the Spanish Venture Capital & Private Equity Association (ASCRI), was attended by investors from 11 countries (compared to eight in 2014). In 2016, 1,750 visitors were in attendance, as well as 701 companies from 29 countries, with internationalisation rising to 28%, and 2,970 one-to-one business meetings taking place, which consolidated Biospain as the fifth largest biotechnology event in the world, having played host to 49 conferences. The commercial fair was larger than during the previous edition, with 233 exhibitors, a 15% increase over 2014. A survey carried out after the event among those who attended found that 84.81% of respondents had identified real business opportunities. The event was described as good or very good by 76.92% of participants. According to the survey, 69.66% of those who attended will do so again during the next edition of Biospain.
Why Spain? In 2015 there were 2,981 enterprises engaged in biotechnology related activities in Spain (+8.72% compared to 2014), of which 654 are dedicated biotechnology enterprises (+4.17%), according to data in the ASEBIO Report 2016. The number of people directly employed by the biotechnology sector reached 182,156 (+2.35%). To register: www.biospain2018.org/registration.html
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Name · Axolabs GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year)
· · · · · · · · · ·
Fritz-Hornschuch-Str. 9 95326 Kulmbach Germany Dr Roland Kreutzer +49-9221-82762-0 +49-9221-82762-99 info@axolabs.com www.axolabs.com 65 2000 (under the name of Ribopharma; acquired by LGC in March 2017) Type of Laboratory · S1, S2 Areas of Activity · Preclinical research solutions with focus on oligonucleotide therapeutics and other nucleic acid medicines, including high-quality oligonucleotide manufacturing, analytics, bioanalytics, lead molecule identification, in vitro and in vivo pharmacology Biological Patents · Proprietary bioanalytics assay for the detection and quantification of oligonucleotides in blood and tissue; proprietary lipid platform for the cellular delivery of nucleic acids External · Axolabs collaborates with the majority Collaborations of research groups in the field of oligonucleotide therapeutics worldwide, including > 10 Big Pharma enterprises, > 100 Biotech companies and > 30 academic research institutes
Request for · Axolabs is looking for partners to Further Collaborations combine our expertise in preclinical development of oligonucleotide therapeutics with promising therapeutic approaches
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Expertise and scientific excellence Axolabs is the leading CRO focused on the discovery and preclinical drug development of oligonucleotide therapeutics and other nucleic acid medicines. Based on our world-leading know-how and 16+ years of experience, we provide high-end preclinical solutions tailored to our clients’ specific needs. As Axolabs is part of the LGC group, our customers benefit from additional resources and expertise right across LGC, including a wide range of analytical services, leading capabilities in CMC, GMP, and research-grade oligonucleotide manufacturing, as well as custom synthesis of specialty phosphoramidites and solid supports.
Services and products Manufacturing ·· High-quality oligonucleotide synthesis – from discovery to pre-clinical and GMP (at LGC Biosearch) ·· Custom-tailored process optimisation ·· Long RNA/DNA, e.g. for CRISPR/Cas applications ·· Chemically modified oligonucleotides and conjugates ·· Custom amidites and solid supports (at LGC) ·· Potency and stability improvement ·· Regulatory documentation ·· Impurity markers and reference standards ·· Lipid synthesis Oligonucleotide and nucleic acid analytics ·· Physicochemical and thermodynamic characterisation ·· Stability determination in biological matrices ·· Identification of metabolites by LC/MS ·· mRNA identity ·· Characterisation of nucleosides and nucleotides ·· Analysis of nucleic acid-protein interactions
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axolabs
Bioanalytical services ·· Detection of oligonucleotides from biological matrices ·· Quantitative detection of mRNA therapeutics from biological matrices ·· GLP-certified test site (also qualified for GCP) ·· Small and large molecules (at LGC) ·· Biomarkers (at LGC) Oligonucleotide lead identification ·· Bioinformatics assessment for sequence pre-selection ·· Drug design and synthesis ·· High-throughput in vitro screening ·· Lead characterisation and optimisation ·· In vivo efficacy and early safety assessment Biological and pharmacological tests and analyses ·· Safety analyses ·· Cell-based assays for cell function, proliferation and toxicity ·· Ligand-receptor interaction and uptake studies/histology ·· Flow cytometry ·· Protein analysis (at LGC) ·· Analysis of mRNA up- and downregulation Platform for functional cell type-specific delivery of oligonucleotides and mRNAs ·· In vitro functional analysis and in vivo models ·· Rational design tailored for specific delivery systems ·· Proprietary lipid nanoparticle formulations CMC analytical services (at LGC) ·· GMP compliant (FDA inspected) ·· Broad analytical capabilities ·· Materials science
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Name · BaselArea.swiss · · · · · · · · · ·
Dufourstrasse 11 4010 Basel Switzerland Christof Klöpper +41-61-295-50-00 info@baselarea.swiss www.baselarea.swiss
LI 20 2016
Areas of Activity · BaselArea.swiss is the official innovation and economic promotion agency for the Swiss cantons of Basel-Stadt, Basel-Landschaft and Jura.
Get connected to our dynamic business community, our top universities, and worldclass research institutions. Our international and multilingual team of experts offers free and confidential services – individually tailored to your needs.
About the Basel region: Europe’s premier life sciences hub With its competitive tax rates, a multilingual, international workforce, liberal labour law, and a suberb quality of life, the Basel region is the perfect location for setting up a business presence. Roche and Novartis, two of the global market leaders, run their global operations from Basel. 700 other life sciences companies are based here, among them international players like Bayer, Lonza and Syngenta. Newcomers such as Basilea, Evolva, Idorsia, and highly specialised companies like Bachem and Polyphor complete the life sciences ecosystem. Not surprisingly, the Basel region is also a hotspot for promising startups. With over 30,000 employees in the life sciences, the area boasts an outstanding talent pool with all kinds of competencies: from research and startups to manufacturing, commercialisation, marketing, and distribution, experienced specialists are available at every stage and for every function of your company. Direct borders to France and Germany, an airport with daily flights within Europe, a close international airport, and a transnational port offer unparalleled accessibility and closeness to strategic European markets.
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Picture: Erich Meyer
Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Social Media Number of Employees Founded (year)
BaselArea.swiss is the official innovation and economic promotion agency for the Swiss cantons of Basel-Stadt, Basel-Landschaft, and Jura. We foster innovation and accelerate business in Switzerland’s most innovative region. Foreign companies and investors receive expert advice and tailored support in setting up their business operations in the region. Entrepreneurs who settle here or start up a new company are offered assistance with the operational implementation of their projects.
baselarea.swiss
Connecting and strengthening the ecosystem BaselArea.swiss helps founders of startups and growing SMEs, predominantly concerned with technology and innovation, with their projects. They receive support through targeted networking with specialists and investors and are offered business startup courses and individual consultations. Every year, BaselArea.swiss organises more than 80 events, workshops, panel discussions, and conferences to help companies accelerate their business development and grow their network in the area’s highly diverse innovation ecosystem. The digital information platform, with news about the region as well as monthly innovation reports, promotes the exchange of ideas and knowledge sharing. Companies newly arriving in the region benefit from this huge network and thanks to the many events and activities get quick access to the local community.
Accelerating healthcare ventures
Picture: Erich Meyer
In 2017, BaselArea.swiss initiated BaseLaunch, an accelerator for healthcare startups, which supports carefully selected ventures with non-dilutive funding, industry access, and knowledge from highly experienced advisors, as well as a state-of-the-art infrastructure. The accelerator embeds participating startups deeply within the Basel region. Over the course of 15 months, founders work with the BaseLaunch team and a network of seasoned professionals to solidify strategy, R&D plans, and operations. BaseLaunch enjoys the backing of leading industry players Johnson & Johnson Innovation, Novartis Venture Fund, Pfizer, Roche, and Roivant Sciences, as well as other public and private partners.
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Name · Biaffin GmbH & Co KG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Websites
· · · · · · · ·
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 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.
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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 product portfolio, 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) for customers’ inhouse 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.
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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)
· · · · · · · · · ·
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
Areas of Activity · | 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
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.
NET WORK
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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 8 th european biotechnology guide 2018
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Multidisciplinary research and education in life science
Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Number of Employees Founded (year) Type of Laboratory Areas of Activity
· · · · · · · · · · ·
Arvo Ylpön katu 34 33520 Tampere Finland Juho Väisänen +358-40-1909834 info@biomeditech.fi www.biomeditech.fi +400 2011 Medical technology Biosciences Biomedical technologies
Request for · www.biomeditech.fi/industrialFurther Collaborations collaboration/
BioMediTech – Institute of Biosciences and Medical Technology – was established in 2011 by the University of Tampere (UTA) and the Tampere University of Technology (TUT) to gather multidisciplinary research in life sciences and medical technology under the same organization. We aim to create new knowledge and clinical/commercial solutions by combining engineering and biology efficiently with modern medicine. Today we have over 300 scientists in more than 30 research groups who conduct research and education in the fields of cell and molecular biology, genetics, biomaterials, biosensors, computational systems, biotechnology, biomedical engineering, and regenerative medicine. Our research groups and collaborators have access to major life sciences research infrastructure at both universities. We also provide our researchers life-sciences-specific innovation services with particular expertise in IPR, business development, quality, and regulatory affairs. BioMediTech is also the local host organisation of the SPARK Finland programme.
Diverse research fields BioMediTech research activities cover diverse fields, from basic cell and molecular biology to applied medical engineering, including biomaterials, stem cells, cancer, immunology, biosensors, imaging, and computational methods, with a common aim of developing personalised medicine via new diagnostic and treatment methods. The research at BioMediTech is at the highest level and has been internationally recognised in many fields, such as genetic alterations in prostate cancer, gene therapy for mitochondrial disorders, bioabsorbable implants such as screws and plates for bone fixation, and jaw bones derived from patients’ own fat tissue. Member of
European Biotechnology NET WORK
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Pictures: Jonne Renvall/University of Tampere
Name · BioMediTech
biomeditech
Research areas and groups Research at BioMediTech can be divided into 7 research areas which contain altogether 33 research groups. The research areas are: ·· Biotechnology ·· Cancer ·· Cell and tissue engineering & biomaterials ·· Imaging and computational biosystems ·· Mitochondria ·· Molecular immunology ·· Sensors, measurements, and stimulation
Three centres of excellence
Pictures: Jonne Renvall/University of Tampere
The Academy of Finland’s Centres of Excellence (CoE) are the flagships of Finnish research. BioMediTech coordinates two of them: FinMIT (2014–2019) in research on mitochondrial disease and ageing, and the Centre of Excellence in Body-on-Chip Research (2018–2025). BioMediTech is also a participating Centre of Excellence in Tumour Genetics Research (2018–2025), coordinated by the University of Helsinki.
Industrial collaboration The cross-disciplinary BioMediTech institute is a perfect option for industry as a Contract Research partner. We offer state-of-the-art infrastructure, high-level expertise, and long-term commitment for industry driven assignments and larger projects. EU- and other public funded research programmes are a perfect platform for industrial partners to integrate with academic research and application development. Analytics and testing services are carried out by our research facilities and skilled operators. The BioMediTech institute and its professionals can also support your organisation and its competence development by organising training courses or offering consulting.
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Name · Boehringer Ingelheim Biopharmaceuticals 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
· · · · · · · · · · · ·
Binger Strasse 173 55216 Ingelheim Germany Dr Julia Knebel +49-6132-77-0 +49-6132-72-0 bioxcellence@boehringer-ingelheim.com www.bioxcellence.com >45,600 in 2016 1885 in Ingelheim, Germany S1 Focus on human pharmaceutical and animal health business
Net Sales · €15,850 million in 2016 Relevant R&D Budget · €3,112 million in 2016 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 143 affiliates and more than 45,600 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 2016, Boehringer Ingelheim achieved net sales of about 15.8 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 lifecycle, transferring customer projects at any stage, delivering to almost any scale. Boehringer Ingelheim BioXcellenceTM makes outsourcing easy.
Boehringer Ingelheim’s BioXcellence™ services At our cell culture sites in Biberach (Germany), Fremont (USA), and Shanghai (China) we have a total capacity of more than 270,000 L with flexible scales for clinical and commercial supply of between 100 L and 15,000 L. At our microbial site in Vienna (Austria) we have around 12,000 L with flexible scales for clinical and commercial supply from 300 L to 6,000 L. We offer the following: ·· Genetic engineering ·· Cell line and strain development ·· Up- and downstream processing ·· Fast and tailored project transfers
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Boehringer Ingelheim
·· L arge-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 BioXcellence™ 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 ·· From DNA to drug product in one seamless, integrated process. ·· Small- 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 >200 projects successfully optimised and transferred. ·· Transparent processes and first-class project management allowing you to step in at any stage of development.
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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 Health l Biotech l Agri-food External · l ALISEI – Italy’s Life Science Cluster Collaborations l Council of European Bioregions l European Biotechnology Network
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 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 the commitment to valorising the life sciences regional ecosystem. Our mission is to generate a positive impact within our national community by sharing innovative products and services and strenghtening 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 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, Universities, 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 know-how, innovation, and passion.
Member of
European Biotechnology NET WORK
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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 incapsulated with nutraceuticals/cosmeceutical action Diagnostics, biosensors and innovative technologies for 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, neurologic …) ·· 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 million. INNOLABS project aims to foster collaboration, transfer of knowledge, and opportunities among SMEs belonging to the fields of ICT, health, biotech, 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. Begun on the 1st of January 2017, the project has a duration of 2.5 years and is supported by Horizon 2020, the EU Framework Programme for Research and Innovation. 8 th european biotechnology guide 2018
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Name · CEBIS International SAGL Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Via Maggio 1C 6900 Lugano Switzerland Mihai Manolache, PhD (CEO – Global Operations) Telephone · +41-91-260-15-75 Email Address · office@cebis-int.com Internet Website · www.cebisinternational.com Social Media · F I Number of Employees · 123 Founded (year) · 2007 Areas of Activity · l Clinical research l Product development l Patient support programmes l Regulatory and pharmacovigilance l Business process outsourcing l New technologies & innovation l Analytical services / testing l Bioinformatics l Consulting services l Contract R&D l Contract manufacture l Medical devices l Pharmaceuticals l Therapeutics l Vaccines (human)
CEBIS – Energizing Discovery CEBIS International is a global patient-centric contract research organization (CRO). We specialize in patient support services, which include facilitating access to newly available medical technologies and treatments under development. CEBIS has expertise in Phase II-IV clinical development studies in the following therapeutic areas: ·· Oncology ·· Hematology ·· HIV-AIDS ·· CNS ·· Immunology ·· Hepathology-Gastroenterology ·· Ob-Gyn ·· UTI ·· ID ·· Respiratory ·· Pediatrics ·· Dermatology ·· Allergology ·· Rheumatology ·· Ophthalmology ·· Intensive Care ·· Anaesthesia CEBIS is headquartered in Switzerland and operates in 29 countries throughout Europe, India, Brazil, China, and the USA, having access to a network of more than 300 research sites and more than 500 principal investigators. We offer a full spectrum of services, including in-vitro testing available across five R&D sites and in-vivo animal testing supported by a network of three animal research facilities. We are fully conversant, and our activities are completely compliant with the regulations of: ·· FDA (US Food and Drug Administration, USA) ·· EMA (European Medicines Agency, Europe) ·· PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
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CEBIS International
·· ANVISA (Brazil National Health Surveillance Agency, Brazil) ·· ROSZDRAVNADZOR (Federal Service for Surveillance in Healthcare, Russia) ·· DFDA (Directorate of Food and Drugs Administration, India) ·· CFDA (China Food and Drug Administration, China) ·· BfArM (Federal Institute for Drugs and Medical Devices, Germany) ·· MHRA (The Medicines and Healthcare Products Regulatory Agency, UK)
We have implemented and adhere to the following guidelines and principles in all our research activities: ·· ICH-GCP (International Conference on Harmonisation-Good Clinical Practice) ·· ISO 14155:2011 (Clinical investigation of medical devices for human subjects – good clinical practice) ·· EFSA (European Food Safety Authority) Our services support the development of pharmaceutical, biotechnology, medical devices, dietary supplements, food for particular medical purposes, and phytochemicals.
Our vision A global leader in patient support and treatment adherence technologies.
Our mission Our mission is to help patients be correctly diagnosed, provide access to the best available treatments, and help them to comply with the requirements for administering their treatments, ensuring high adherence. We help patients access new treatments available on the market, or new treatments under development.
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Name · CEVEC Pharmaceuticals GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year)
· · · · · · · · · · ·
Gottfried-Hagen-Straße 60–62 51105 Cologne Germany Dr Nico Scheer +49-221-46020800 +49-221-46020801 info@cevec.com www.cevec.com
I 30 2003
Areas of Activity · Centre of expertise for the production of recombinant proteins previously out of reach (CAP-Go) and for scalable gene therapy vector production (CAP-GT) using a unique human cell production system.
CEVEC is a centre of expertise for the production of biopharmaceuticals using a unique human cell-based expression system.
CAP®Go Technology – Production of recombinant proteins previously out of reach CAP®Go addresses the increasing need in the pharmaceutical and biotechnology industries for the manufacture of difficult to express therapeutic glycoproteins. Using CAP®Go it is possible to produce glycoproteins with tailor-made or fully human glycosylation patterns for significantly improved physicochemical and pharmacological properties. Therapeutic proteins expressed on conventional mammalian expression platforms like CHO or HEK293 cells often do not match the glycosylation and pharmacokinetic profiles of the naturally occurring proteins. CAP®Go Technology provides an efficient way, with up to 10fold higher yields than conventional cell lines, to glyco-optimised proteins that previously have been out of reach to the life science industry. CAP®Go derived glyco-optimised proteins show authentic human posttranslational modifications. CEVEC’s regulatory endorsed CAP ® Go expression platform comprises a comprehensive portfolio of glycooptimised human suspension cell lines that have different glycosylation capabilities. CAP®Go allows for the optimisation of complexly glycosylated proteins such as plasma proteins, coagulation factors, cytokines and other high molecular mass multimeric proteins.
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CEVEC Pharmaceuticals
CAP®GT Technology – Scalable gene therapy vector production The ability to produce viral vectors in a fully scalable industrial process is a main bottleneck for commercial gene therapy applications. So far, industrial scale vector production could not be efficiently addressed by conventional expression systems such as HEK293. CAP®GT is a novel, fully developed and regulatory endorsed expression platform for the scalable industrial production of viral vectors for gene therapy applications. CAP®GT cells propagate a broad spectrum of viral species supporting lentiviral (LV), adenoviral (AV) and adenoassociated viral (AA V) vectors. Growing in serum-free suspension culture, CAP®GT grows to high cell densities, reduces production costs, and allows for safer and more efficient scale-up when compared to adherent cell culture systems. A helper-free CAP®GT AAV packaging cell line is available for fully scalable stable gene therapy vector production. Independent study results show that CAP ® GT derived lentiviral vector production delivers vector titers comparable to or even exceeding production with HEK293 cells. As demonstrated in adenoviral vector production runs, the CAP®GT platform offers the safe production of adenoviral vectors. Unlike HEK293 cells, no replication competent adenovirus (RCA) can be detected in the vector preparation
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Name · Charles River Address/P.O. Box Postal Code/City Country Contact Person Telephone
· · · · ·
251 Ballardvale Street Wilmington, MA 01887 United States of America Genevieve Glazier +44-1875-614545 (UK) +1-877-CRIVER-1 (US) Fax · +44-1875-614555 Email Address · AskCharlesRiver@crl.com Internet Website · www.criver.com Social Media · FL I Number of Employees · more than 11,000 Founded (year) · 1947
As the world’s largest and most advanced Discovery & Safety contract research organisation, Charles River is committed to helping our partners expedite their nonclinical drug development with exceptional safety assessment services, state-of-the-art facilities, and expert regulatory guidance. Sharing our partners’ goals to make a positive impact on worldwide health, we have proudly supported the development of ~74% of the drugs approved by the FDA in 2017. From individual specialty toxicology and IND-enabling studies to tailored packages and total analytical support, our team can design and execute programmes that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. With more than 11,000 employees in more than 70 facilities across the globe, we continue to grow and evolve, keeping pace with the ever-changing landscape of today’s drug development. Our promise, “Every Step of the Way,” reflects a mission to provide end-to-end support of the entire drug development continuum to academia, small biotech startup firms, big pharma, and industrial and agrochemical companies. With every programme we support, we continue to focus on improving quality of life by helping to identify and develop compounds that prevent, treat, and cure disease. This philosophy has fueled Charles River’s success, attracting talented, passionate people who come to work every day eager to face the next big challenge. The longevity of many of our employees’ tenure is both a reflection of and testament to an environment that champions research, innovation, and collaboration and to a shared, deep commitment to the organisation’s goals. By continuing to grow in response to the needs of our clients, we now offer the most comprehensive, integrated portfolio of drug development products and services available from a single global provider, spanning the continuum from early research to the support of marketed products. Whether we are helping to chart the course from bench to clinic, or working to achieve a study milestone, we are proud to partner with our clients on their journey of bringing new therapies to market.
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CHARLES RIVER
Basic research · Research animal models · CRADL® · Genetically engineered models and services · 360 Diagnostics™ Discovery · Target discovery and validation · Assay development and screening · Synthetic, medicinal, and process chemistry · In vitro ADME · In vitro and in vivo pharmacology · Discovery pharmacokinetics Safety assessment · Investigational New Drug (IND) programmes · Toxicology · Laboratory sciences · Safety pharmacology · Anatomic and clinical pathology · Environmental impact assessment of human pharmaceuticals · Drug metabolism and pharmacokinetics Clinical support · Clinical sample analysis · Specialty toxicology Manufacturing support · Manufacturing and production · Biologics testing solutions · Microbial solutions · Endosafe® endotoxin testing · Celsis® microbial detection · Accugenix® microbial identification and strain typing Support · Scientific advisory services · Insourcing solutionsTM · RightSourceTM · Charles River Campus
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Name · Choose New Jersey, Inc. Address/P.O. Box · 201 Rockingham Row Princeton Forrestal Village Postal Code/City · Princeton, NJ 08540 Country · United States of America Contact Person · Cathy Scangarella Telephone · +1-609-297-2200 Email Address · cscangarella@choosenj.com Internet Website · www.choosenj.com Social Media · FL I Number of Employees · 12 Founded (year) · 2010 Areas of Activity · Economic development
New Jersey – a leader in biopharmaceutical manufacturing Companies from around the world are locating and expanding their operations in New Jersey U.S.A. when it’s time to manufacture their medicines, and with good reason. Pharmaceutical manufacturing in New Jersey began more than 100 years ago and continues to be one of the state’s greatest strengths. More than 260 biopharmaceutical manufacturing facilities operate in New Jersey, including global leaders Bristol-Myers Squibb, Allergan, Merck & Co., and Lilly. Novartis is manufacturing its new CAR-T treatment, Kymriah, in New Jersey for patients in countries worldwide. That is why when Ferring Pharmaceuticals made the decision to bring manufacturing to the U.S., it decided to choose a New Jersey location. The state had everything it was looking for: proximity to major cities, world-class academic institutions, and access to an experienced workforce. Ferring is not alone. Drug makers ForDoz Pharma, Hovione, Teligent, Advaxis, MSN Pharmaceuticals, and Aurobindo are among the companies that have recently expanded their manufacturing footprint in New Jersey. In fact, the number of pharmaceutical and medicine manufacturing establishments grew by 10.7 percent from 2011 to 2016, demonstrating that companies recognize the value of a New Jersey location.
A highly specialised talent pool New Jersey’s economy is 89 percent more concentrated in the biosciences than the U.S. average and this high degree of specialisation spans four of the five major industry subsectors – drugs and pharmaceuticals; research, testing, and medical labs; bioscience-related distribution; and medical devices. No other U.S. state holds this distinction. As home to the headquarters or major facilities of 13 of the world’s top 20 biopharmaceutical companies, it
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choose new jersey
should come as no surprise that New Jersey has a pool of specialised talent that understands and has experience in manufacturing. While New Jersey is ranked the third largest life sciences cluster in the U.S., it boasts the highest concentration of biopharmaceutical manufacturing expertise. New Jersey has more than twice the manufacturing workforce as the Greater Boston/ Cambridge area. This high concentration of talent gives companies the ability to recruit the workforce they require to ensure successful operations today, as well as the ability to grow in the future.
Pioneering the future of biopharmaceutical manufacturing New Jersey’s rich legacy of innovation is attracting companies from around the world. The state ranks in the top tier for innovation, patents issued, and venture capital investments in bioscience-related companies. Fifty percent of FDA approvals in 2017 were awarded to companies with significant operations in New Jersey. This innovation extends to next-generation manufacturing. As the biopharmaceutical industry looks for ways to reduce time to market and ensure consistent product quality, it has placed an increasing focus on the technology used for manufacturing. New Jersey is once again at the forefront of innovation, pioneering the future of continuous manufacturing. In fact, the New Jersey Continuous Manufacturing Institute, a joint venture between the New Jersey Innovation Institute and Rutgers, the State University of New Jersey, is building on more than a decade of pioneering work in continuous manufacturing at the Rutgers Engineering Center for Structured Organic Particulate Systems. As the science of medicine evolves and new patientcentric drugs receive approval, global biopharmaceutical manufacturers choosing to locate and expand in New Jersey will have access to the specialised workforce, new technologies, and knowledgeable partners to go boldly into a new era of bringing life-changing drugs to market. 8 th european biotechnology guide 2018
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Name · CO.DON AG Address/P.O. Box · Warthestr. 21 (Headquarters) Postal Code/City · 14513 Teltow Country · Germany Ernst-Reuter-Platz 2 10587 Berlin Germany Contact Person · Matthias Meißner, MA (Director Corporate Communications/ IR/PR) Telephone · +49-30-240352-330 Fax · +49-30-240352-309 Email · info@codon.de Website · www.codon.de Number of Employees · 100 (2018) Founded (year) · 1993 Type of Laboratory · GMP/Integrated Isolator Technology (IIT) Areas of Activity · Tissue Engineering Biological Patents · On cell-based human tissue engineering therapeutics External · Various ongoing projects with several Collaborations well-renowned hospitals, universities, and university hospitals in Germany and Europe in the field of product distribution (Germany), product development, clinical evaluation, and research Request for · CO.DON AG is seeking national and Further Collaborations international corporate partners who have substantial resources in the field of tissue engineering and regeneration for distribution and marketing of the company’s products (internationally) as well as for the development of product lines.
The company CO.DON AG develops, produces and markets autologous cell therapies for the minimally invasive repair of knee cartilage defects following trauma or degeneration. The medicinal product is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). The method has been used for more than 10 years in over 150 clinics to treat more than 12,000 patients. In Germany, the statutory health insurance companies have reimbursed the treatment of knee and hip joints since 2007. In July 2017 the company received EU marketing authorisation for its articular cartilage product, which is distributed under the name of Spherox. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Ralf M. Jakobs. CO.DON AG manufactures cell-based tissue engineering therapeutics of the highest purity and to the highest quality standards. Its products represent a revolutionary process in the biological regenerative treatment of articular cartilage defects. The products are 100% autologous and free of additives, setting the stage for the highest level of personalised healing. Because no exogenous materials are used, the risks of rejection, inflammation, and infection are very low. Due to a minimally invasive or arthroscopic application of the product, surgery and rehabilitations times can be significantly reduced. Moreover, results of recent trials provide evidence for the effectiveness of the product. CO.DON AG has been certified in accordance with European Guidelines for Good Manufacturing Practice (EU-GMP) since 1997. In 1997 CO.DON AG was the first biopharmaceutical company in Europe to be granted a permit for the manufacture of autologous chondrocyte transplants under section 13 of the German Drugs Law (AMG). CO.DON has also developed a proprietary platform technology: Integrated Isolator Technology (IIT).
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CO.DON
Technology platform – Integrated Isolator Technology (IIT) CO.DON has an established tissue engineering programme for the development, production, and distribution of biotechnological products for the treatment of articular cartilage defects. For the manufacturing process and quality control of autologous tissue engineering therapeutics the company has developed its own clean room production plant with proprietary Integrated Isolator Technology (IIT) (a cleanroom in a cleanroom) and thus set a totally new standard for the manufacture of cell-based tissue engineering therapeutics in Germany and worldwide. In 2018, the company initiated the setup of a second production site in Leipzig. With this, CO.DON is entering a new dimension: once all the work is finished the production site will be one of the world’s largest and most modern plants for the industrial-scale production of human cells. It will enable the company to ensure the supply of the highest quality cell therapy products to their customers in Germany and Europe going forward. CO.DON’s technological, production, and regulatory expertise makes the company a first mover in the market for biological cartilage replacement and a provider of highly effective, safe treatment options between pain therapy and endoprosthetics, with the aim of becoming the market leader in arthrosis prophylaxis. Moreover, the product is currently the only cell-based medicinal product for the regenerative treatment of knee cartilage defects that is available and authorised EU-wide, meaning that there is currently no European competitor in the market segment. With that, CO.DON has the chance to open up a market that is worth millions and to raise its company value. CO. DON founded subsidiaries in the UK (2017) and the Netherlands (2018) as first steps to developing this promising market in line with the company’s strategy.
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Name · Coriolis Pharma Research 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
· · · · · · · · · · · · ·
Fraunhoferstr. 18 b 82152 Martinsried Germany Dr Jörg Müller +49-89-41-77-60-111 +49-89-41-77-60-222 joerg.mueller@coriolis-pharma.com www.coriolis-pharma.com
I 80+ 2008 Contract research and development Formulation excellence for biopharmaceuticals l Liquid and lyophilised formulation development l Lyophilisation process development Leading analytical competence for biologics l Biophysical characterisation l Higher order structure (HOS) Level: R&D, GMP, S1 (BSL1), S2 (BSL2)
External · Experience with 500+ different Collaborations molecules gained in 1000+ projects Request for · We successfully serve customers Further Collaborations worldwide in all stages of product development (from early R&D up to marketed products). Our customer range includes small virtual biotech firms, mid-size pharma-biotech up to TOP20 pharma-biotech companies. We’re eager to discuss formulation, stability, and analytical challenges you might face. We provide our customers with expert support on a high-quality scientific level, vast experience in the biopharmaceutical field, flexibility and responsiveness.
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Coriolis is a world-leading independent contract research and development organisation specialised in biopharmaceutical formulation and drug product development, including lyophilisation processes and analytical development for proteins, peptides, monoclonal antibodies, RNA/DNA, etc., as well as vaccines. This contains highly concentrated protein formulations or developments for subcutaneous administrations or other complex formulations. This is complemented by outstanding analytical capabilities and know-how in the fields of protein characterisation (e.g. higher order structure characterisation, aggregation, subvisible particles, surfactant characterisation, etc.). Coriolis is expert in highly specialised and innovative analytical technologies (e.g. analytical ultracentrifugation (AUG), Resonant Mass Measurement (RMM), quantitative Far- and Near-UV circular dichroism spectroscopy (CD). Most recently we also offer polysorbate analytics such as quantification and characterisation of degradation products. In addition, we also offer as standalone services GMPcompliant analytics for subvisible particle analysis and aggregation characterisation (e.g. light obscuration (LO), flow imaging spectroscopy (MFI), asymmetrical flow field-flow fractionation (AF4)), and other innovative techniques. As of 2017 Coriolis has received the regulatory approval for the operation of a genetic engineering facility of safety level S2 (BSL2), allowing handling of S1 and S2 classified samples. For gene therapy and viral based vaccine products Coriolis is equipped with state of the art analytical equipment to support particle morphology, aggregation, size distribution, and purity analysis using e.g. AUC, transmission electron microscopy (TEM), nanoparticle tracking analysis (NTA) and dynamic light scattering (DLS).
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coriolis pharma research
Coriolis is specialised in the provision of: ·· Formulation development services for liquid and lyophilised products · Pre-formulation and candidate selection · Early stage formulation development · Late phase formulation development · Lyophilization cycle optimisation · Scale-up and transfer studies ·· Support in container closure system selection ·· In-use stability studies ·· Stability testing including forced degradation studies ·· R&D and GMP-compliant contract analytical services ·· Orthogonal analysis of subvisible aggregates and particles ·· Testing of S1 and S2 GMO material ·· Outstanding scientific expertise Coriolis supports customers in R&D development projects, e.g. by developing the most robust formulation or lyophilisation process for a biopharmaceutical, identifying suitable stability-indicating analytical methods to monitor real-time and accelerated stability studies, or support in process trouble-shooting. Freeze-drying capabilities up to 6 sqm shelf area, featuring state-of-the-art process analytical tools, including controlled nucleation, ensure that we develop and optimise lyophilisation processes specifically for our customers’ needs that are ready to be up-scaled and transferred to commercial production units worldwide. With a strong expertise in aggregate and subvisible particle testing, Coriolis supports in method development and validation for low-volume applications (e.g. ophthalmic products) and/or high viscosity material in a GMP-compliant environment. Equipped with several AF4, HP-SEC, multiple AUC (including Optima AUC), and DLS systems, Coriolis can perform comprehensive studies on aggregation characteristics.
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Name · CureVac AG Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity
· · · · · · ·
Paul-Ehrlich-Str. 15 72076 Tübingen Germany Verena Lauterbach (Senior Manager Communications) +49-7071-9883-1756 +49-7071-9883-1101 verena.lauterbach@curevac.com www.curevac.com ~350 2000 Research, development, and manufacturing of therapeutics based on messenger RNA (mRNA) l Cancer therapeutics l Prophylactic vaccines l Molecular therapies
External · CureVac AG collaborates with Collaborations l Boehringer Ingelheim l Eli Lilly & Co l CRISPR Therapeutics l Arcturus Therapeutics l Bill & Melinde Gates Foundation l and others
CureVac – The RNA people ® CureVac is a clinical stage biopharmaceutical company, based in Tübingen. The company is pioneering the use of natural and chemically unmodified messenger RNA (mRNA) as a data carrier, to instruct the body to produce its own proteins capable of fighting a wide range of diseases. CureVac’s broadly protected mRNA platform allows for rapid, low-cost production of multiple drugs and vaccines.
CureVac’s RNA technology – inspired by nature The natural molecule mRNA offers enormous potential to be used as a data carrier for “healthy messages”. In the body, mRNA translates the genetic message encoded in DNA into a corresponding protein countless times per day. CureVac has adapted from nature a way to utilise mRNA to communicate with the body: the RNA people add the medically desired message to synthetically produced mRNA, so that the body can read it as it does with its own mRNA.
mRNA cancer therapeutics CureVac’s mRNA-based cancer vaccines represent a potential novel approach in cancer treatment. For the first time mRNA could be optimised to mobilise the patient’s own immune system to fight the tumour with a specific immune response. CureVac also explores combination approaches with checkpoint inhibitors as well as innovative routes of administration to treat cancer with RNA. In the field of cancer, CureVac collaborates with Boehringer Ingelheim, who in-licensed the lung cancer immunotherapy CV9202 in September 2014. CureVac also partners with Eli Lilly & Co, the Cancer Research Institute and Ludwig Cancer Research and others.
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curevac
mRNA prophylactic vaccines mRNA-based prophylactic vaccines can be developed against almost any infectious disease and can be produced rapidly. In July 2017, CureVac published results of its phase I clinical trial with a prophylactic rabies vaccine. The study was the first worldwide in-human proof-of-concept clinical trial of a prophylactic mRNA-based vaccine. Data from the study indicate that the vaccine is generally safe with a reasonable tolerability profile and induces boostable functional antibodies against a viral antigen when administered using a needle-free jet injection device. CureVac is developing second generation prophylactic vaccines with an optimised formulation. In the field of prophylactic vaccines, CureVac collaborates with the Bill and Melinda Gates Foundation, which has also invested 46 Mio Euro in the company. Furthermore CureVac partners with IAVI in developing mRNA-based vaccines.
mRNA-based molecular therapy CureVac’s technologies RNArt ® and RNAntibody ® are being developed as molecular therapy to trigger the body’s own production of therapeutic proteins including antibodies. Without stimulating the immune system, this therapy can, for example, be used for protein replacement or passive immunisation.
mRNA manufacturing Since 2006, CureVac has been operating the first GMPcompliant production plant worldwide, with two multiproduct suites. In 2017, the company completed the development of its third in-house suite which is capable to deliver for late stage clinical trial supply. In 2017, CureVac started the construction of a new building, which is designed for the development of a GMP production process on an industrial scale. The new facility, GMP IV, is expected to be fully commissioned in 2019. 8 th european biotechnology guide 2018
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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 17 2009 l Chemistry l Genetic engineering l S1 Biotech lab l access to S2 Biotech lab
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
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Enzymicals Enzymes | Chemicals | Solutions Enzymicals AG is your experienced partner for biocatalytic synthesis. An interdisciplinary team of 17 scientists and technicians is currently engaged in providing integrated solutions for industrial biocatalysis. The focus of the independent SME is the development and production of enzymes, the chemo-biocatalytic synthesis of fine and specialty chemicals, as well as the development, scale up, and piloting of robust chemobiocatalytic processes. These core areas are combined to realise tailor-made solutions for custom development and manufacturing. Our continuous activities in academic partnering and industrial collaborations result in the delivery of state-of-the-art concepts which are applicable at commercial scale.
Products & services Tailor-made enzymes, customised chemicals, and individual process solutions Enzymicals 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 e.g. transaminases, monooxygenases, halohydrin dehalogenases, imine reductases, and hydrolases at desired quality grades to meet customer-specific demands with top performance. Selected products are incorporated in our online catalogue. We deliver concept-to-completion comprehensive solutions to create high-performance protein-based products and processes. For this, we discover and produce enzymes based on the demands of our customers and partners. Our technology platform covers the identification of suitable catalysts from strain or enzyme collections, databases, or metagenome libraries, as well their functional expression in a range of microbial host systems. Additional we offer tailor-made protein expression and optimisation service. In this way, almost any biocatalyst of interest can be supplied to analytical and commercial scale. A catalyst suitable for the pro-
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Enzymicals
duction of your target compound can be optimised via our protein engineering technology to provide the best performance available. 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 synthesis of your desired compound, which include feasibility studies as well as the process development and its piloting. For this we are able to combine efficient enzymatic and chemical synthesis steps. Together with our network partners, we expand our service 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 enabled us to increase the speed of delivery of effective solutions and expand our business along the whole value chain of the white biotechnology industry.
Management Dr Ulf Menyes (CEO)
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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
· · · · · · · · · ·
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
Areas of Activity · 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 92,000 square metres and 24 facilities located in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, New Zealand, Spain, Sweden, Switzerland, UK, and the US, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. Furthermore, we have teams of scientists placed at more than 70 client facilities worldwide 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 materials, process intermediates, drug substances, drug products, and manufacturing support, as well as broad technical expertise in Bio- chemistry, Molecular & Cell Biology, Virology, Chemis- try, and Microbiology. Our focus in Germany lies on bioassays/Biacore, microbiology, in vitro toxicology, and immuno- and bioana-
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Eurofins Biopharma Product testing
lytical studies. Additionally we work in close cooperation with BSL BIOSERVICE Munich, an internationaly active con- tract research organisation, to assess biological safety and activity of bio-/pharmaceuticals and medical de- vices.
Our services at a glance ·· ·· ·· ··
Toxicology/Pharmacology/Biocompatibility Bioanalytics Immunoanalytics Bio-/Pharmaceutical Lot Release and Stability Testing (GMP) ·· Microbiology ·· Bioassays/Biacore In addition we offer the flexibility to manage your testing programmes more efficiently with a choice of three unique service models, including our award-winning Professional Scientific Services ® (PSS), Full Time Equivalent (FTE), or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals.
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 Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging with them to meet their unique out- sourcing needs.
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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.
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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:
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"$ $ 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 composed less cars to 7.8 million Equivalent LessC0fuel and Reduced bers,membership 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¡ EuropaBio’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 andwww.efi animal bforum.com): health care, dithe Biobased Economy (EFIB, *7- 9;8,.<<.< >; ,8;98;*=. 6.6+.;< 1*?. * @2-. range of activities: human and animal crop health care, diagnostics, bio-informatics, chemicals, protection, an event providing insight in the exciting and 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 million tonnes <.;?2,.< Greener transport thanks to biofuels, emissions. of CO233 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. Themanufacturing common denominator among all our opment, testing, 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 theproducts use of biotechnology anycorpostage of Materials More of effective detergents the electricity used on of biotechnology and processes. Our from renewable resources allow to save up to 30% (including plastics) made 27<=2=>=.< $1. ,86687 -.78627*=8; *6870 *55 8>; members is the use of biotechnology at any stage of 30°C laundry by washing at on instead of fossil fuels of the electricity used research, development or manufacturing. from renewable resources allow to save up to 30% (including plastics) made rate members have a wide range 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 dynamic manufacturing. of the electricity used from renewable resources We lead an innovative and industry and memand animal healthcare, diagnostics, bio-informatics, laundry by washing at 30°C instead of fossil fuels ;.<.*;,1 -.?.5896.7= 8; 6*7>/*,=>;270 We lead anthe innovative and dynamic industry and members have opportunity to play an activeand roleenviin EuropaBio’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 EuropaBio’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, fi nancial, 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.
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2017 EuropaBio SME Awards in the European Parliament
We lead an innovative and dynamic industry and members have the opportunity to develop EuropaBio’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. 8 th european biotechnology guide 2018
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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 · Twitter, LinkedIn Number of Employees · > 2,100 Founded (year) · 1993 Type of Laboratory · Chemical, biological, cell culture S1, S2 Areas of Activity · Drug discovery and development solutions as well as proprietary research with focus on CNS/neurology, diabetes and complications, pain, inflammation, oncology, infectious diseases, as well as respiratory illnesses and fibrosis, iPSC Annual Turnover · €164.5m (2016) Relevant R&D Budget · €18.1m (2016) Biological Patents · A broad portfolio of patent families relating to compounds, targets, and assays External · The company is working with more than Collaborations 250 pharma and biotech companies, not-for-profit organisations, academia, and foundations on a global basis. Request for · Our team of business development Further Collaborations managers are happy to discuss our R&D solutions, in- and out-licensing opportunities, and how we can assist you in meeting your drug discovery and development needs. For more information, please contact us at info@evotec.com.
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Evotec is a globally operating drug discovery partnership company headquartered in Hamburg, Germany. With a large pool of highly experienced scientists, state-of-the-art technology platforms, and first-class scientific operations, Evotec provides comprehensive one-stop drug discovery solutions. The company has key therapeutic expertise in the areas of neuronal diseases, diabetes (including complications), pain and inflammation, oncology, infectious diseases, respiratory illnesses and fibrosis. Evotec aims to identify and develop first-in-class and best-in-class differentiated therapeutics for collaborators or for its own 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: to become the leading drug discovery solutions provider by building a partnered product pipeline based on the highest-quality drug discovery science and through innovative collaborations. Evotec is a publicly listed stock corporation operating under German law. The company handles its international business from major operating sites in the UK, Italy, Germany, the USA, and France. Building on its expertise in the field of drug discovery services, Evotec has evolved into a drug discovery engine in its own right, with its two business segments EVT Execute and EVT Innovate. These segments effectively process various project types operating from one common drug discovery and development platform.
EVT Execute – speed, expertise, and new technologies Evotec’s drug discovery platform and development services deliver an industrialised, cutting-edge, comprehensive, and unbiased infrastructure to meet the industry’s needs for innovation in drug discovery and accelerated population of its drug development pipelines. The EVT Execute segment provides stand-alone or integrated drug discovery and development solutions on a typical fee-for-service basis or through a
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evotec
variety of commercial structures including research fees, milestones, and/or royalties. EVT Execute contributes efficiency, project management, and speed to the drug discovery and development process. The company continuously upgrades its platforms and has recently extended its offerings along the drug discovery value chain to include Investigational New Drug (“IND”) submission (INDiGO) and high-end CMC manufacturing processes.
EVT Innovate – source of new pipeline entries The EVT Innovate segment focuses on building a longterm co-owned pharmaceutical pipeline. Evotec’s programmes focus on first-in-class and best-in-class projects based on innovative biology or chemistry. Through its EVT Innovate segment, Evotec builds BRIDGES with academia such as LAB282 (Oxford, UK) and LAB150 (Toronto, Canada), which identify and translate promising projects out of academia through access to Evotec’s industrial-scale discovery platforms and expertise. Evotec has expanded its EVT Innovate segment through equity participation in selected companies.
Paradigm shift in drug discovery Over the last six years, Evotec has built an industrialised induced pluripotent stem cell (iPSC) infrastructure. The company’s iPSC platform is among the largest and most sophisticated in the industry, and has been developed to take iPSC-based drug screening to the highest industrial standards in terms of throughput, reproducibility, and robustness.
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Name · FGK Clinical Research GmbH Address/P.O. Box Postal Code/City Country Contact Persons Telephone Emails
· · · · · ·
Heimeranstr. 35 80339 Munich Germany Dr Edgar Fenzl, Martin Krauss +49-89-893-119-0 edgar.fenzl@fgk-cro.com martin.krauss@fgk-cro.com Websites · www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com Number of Employees · > 100 Founded (year) · 2002 Areas of Activity · Full service CRO (contract research organization) offering a complete range of clinical development and consulting services: l Regulatory Affairs l Project Management and Monitoring l Medical Safety/Pharmacovigilance l Data Management l Biostatistics and Programming l Quality Assurance With our daughter companies, FGK Pharmacovigilance and FGK Representative Service, we also offer pharmacovigilance services and legal representation.
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Company overview FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and mid-sized biotech, pharmaceutical, or medical device companies. FGK was founded in 2002 and currently has more than 100 employees – all very experienced in their respective fields and trained according to the latest standards in clinical research. Covering all phases and areas of clinical development, we have a special focus on phase II and phase III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology. Besides our services for drug development, we also help to guide all kinds of innovative medical devices through the increasingly demanding framework of clinical investigations. FGK’s headquarters are located in Munich. We directly supervise international projects and operate Europewide with staff located in our headquarters in Munich and in our subsidiaries in the Czech Republic, Hungary, Poland, and the UK. With regard to monitoring, we cover many countries with our own staff and have established long-term partners for some European countries and the US/Canada.
Our approach to a project The main philosophy for FGK is to prepare and conduct studies in close cooperation with the sponsor. Thus, we not only closely interact with our clients throughout the project but long beyond it, as maintaining a good relationship forms the basis for long-term cooperation. Next to that, FGK is a full-service CRO which can conduct a study from the planning to the final report and beyond. Our operational team works hand in hand with all other departments involved. Distances for internal information flows are very short since the majority of staff is in-house and located in the Munich HQ. This also applies for the project manager, who is the central contact person delivering all required information to the sponsor.
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Timely approvals and efficient trouble-shooting are achieved by the combination of this centralized project management together with local monitoring as well as local expertise in regulatory submissions within the country of study conduct.
Services We design a project according to our clients’ needs and local practice, help identify potential investigators, take care of regulatory submissions and contract negotiation, and set up effective project management and monitoring of sites. We also perform data management including data collection, data validation, query management and overall biostatistical analysis by means of the latest technological tools. Through cooperation with an online solutions provider, we offer top-notch electronic management tools and eCRFs. We also cover medical writing and provide IT support. FGK operates according to a regularly reviewed and updated set of SOPs and its quality system is audited on a regular basis. Our Quality Assurance department regularly performs audits on behalf of sponsors and assists during inspections from regulatory bodies around Europe. We take pride in strictly adhering to GCP principles and keeping up with ever-changing national legislations and requirements. Since 2017, we have also been participating in an independent “GCP Qualification Programme�, offering our clients the possibility to obtain an all-encompassing audit report from a third party.
Special services FGK Clinical Research has two daughter companies: FGK Pharmacovigilance and FGK Representative Service. FGK Pharmacovigilance offers a broad range of pharmacovigilance services; FGK Representative Service offers legal representation for non-European customers.
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Name · FILTROX Group Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Areas of Activity
· · · · · · · · · · ·
Moosmühlestr. 6 9000 St. Gallen Switzerland Ralph Daumke +41-71-272-9236 +41-71-272-9100 r.daumke@filtrox.ch www.filtrox.com 300 1938 l Microfiltration and treatment of high value liquids l Depth filtration l Single-use cell removal l Activated carbon filter
External · l ZHAW Wädenswil, Switzerland Collaborations l FH Trier, Bioverfahrenstechnik Prof. Kampeis, Germany l HES-SO, Institut of Life Technologies, Switzerland Request for · Partners for business and product Further Collaborations development
Company profile As the global leader in depth filtration, the FILTROX Group offers complete solutions for filtration of valuable liquids using depth filter systems. We are experts in the development, manufacturing, production, and delivery of Swiss quality products for a wide range of applications in the pharmaceutical, biotechnology, chemicals, and cosmetics industries. Since 1938, filter media and filter systems have been developed and manufactured at our corporate headquarters in St. Gallen. Based on this experience, we offer a complete range of products and solutions. With the FILTROX Academy we also offer filtration trainings, seminars, audits, and customised trainings. It is our pleasure, to share our expertise in the area of application and filtration technology, to optimise your processes. The FILTROX Group has a worldwide distribution network, which provides comprehensive technical support and will help you in improving your filtration process. Our well trained sales teams provide you with on-site assistance and ensure a rapid product availability worldwide. For more information, please visit our website.
Products FILTRODISC™ BIO SD FILTRODISC™BIO SD is the first depth filter using the advantages of the well-established method of alluvial (cake or precoat) filtration technology in a disposable format. FILTRODISC™ BIO SD is used e.g. for singleuse cell separation, as the system is fully scalable and disposable, fulfilling all validation requirements. Depth filter sheets and lenticular filter modules: PURAFIX® depth filter sheets have been specifically developed for use in critical applications in the pharmaceutical or biological industries. They are characterized by their extremely low levels of ions and pyrogens. SYNTHAFIX™ filter sheets, reinforced with HDPE fibres, are typically used when a very high wet strength or stability against cellulase enzymes is required. The new SYNTHFIX™ P media has been developed specifically
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filtrox
for the high requirements of the life sciences industry. With its very high stability, easy handling, and efficient filtration properties it is ideal for precoat or cake filtrations, e.g. in the plasma fractionation industry. CARBOFIL™ sheets allow the user to handle immobilized activated carbon in a much cleaner way than with loose carbon powders. It offers a lot of potential for API manufactures around the world to optimise their processes. Plate and frame filters and module housings: NOVOX® systems are high-precision stainless steel plate and frame filters for heavy duty use. The NOVOX® CP filter is designed and built for pharmaceutical and other critical applications. The plates are available in stainless steel, polypropylene or PVDF (other materials on request). The NOVOX® CP is an enclosed filtration system completely sealed for CIP without filter sheets. It eliminates any drip loss and prevents the liquid from having contact with the outside environment. DISCSTAR™ is a highly precise stainless steel filter housing for filter modules for everyday use. The enclosed system allows for depth filtration to be carried out without drip loss. The DISCSTAR™ P, with its tri-clamp connections and pharma-approved valves and pressure gauges, is the ideal housing for highly sensitive applications in life science, pharmaceutical and biotech applications (biomass removal), APIs, and injectables.
Locations FILTROX AG Switzerland All depth filter sheets and modules for pharmaceutical applications manufactured here. FILTROX France s.a.r.l., Sales office FILTROX North America USA, Sales office FILTROX MICROFILTRACIONES, SA de CV Mexico, Sales office FILTROX (Shanghai) Filtration System Co., Ltd. China, Sales office FILTROX UK & Northern Europe UK, Sales office FILTROX Southern Europe Spain, Sales office FILTROX Asia-Pacific Pte Ltd. Singapore, Sales office 8 th european biotechnology guide 2018
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Name · Innovation and Start-up Center 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 50 companies External · Collaborations with the scientific Collaborations institutes on the Campus Martinsried
Hotspot 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 50 biotech companies with over 600 employees are located. An essential criterion for the success of the IZB is its close proximity to outstanding research at the Ludwig Maximilian University (LMU) and renowned biotechnology research establishments on the Campus Martinsried, such as the Max Planck Institutes of Biochemistry and Neurobiology.
Magnet for biotech start-ups Since 1995, the Planegg-Martinsried location, now covering 23,000 m 2, 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 innovations are combined on one campus. Located in the direct vicinity are other institutes such as the Max Planck Institutes of Biochemistry and Neurobiology, the HelmholtzZentrum München (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),
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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 hotel with 42 rooms and its own restaurant will accommodate visiting scientists from all over the world. The core element is the Faculty Club G2B (Gateway to Biotech). 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 (Gateway to Biotech) ·· Restaurants: SEVEN AND MORE and Café Freshmaker ·· 2 day care centres (BioKids & BioKids2) 8 th european biotechnology guide 2018
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Name · Fraunhofer Institute for Toxicology and Experimental Medicine ITEM Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Telephone · Fax · Email · Number of Employees · Founded (year) · Type of Laboratory · Areas of Activity ·
Inhoffenstr. 7 38124 Braunschweig Germany Dr Holger Ziehr (Division of Pharmaceutical Biotechnology) +49-531-6181-6000 +49-531-6181-6099 biopharmaceutical-services@item. fraunhofer.de 303 (Pharmaceutical Biotechnology: 45) 1981 S1, S2, clean rooms of grades D, C, and B Biopharmaceutical consultancy service, cell line development, contract manufacture of cell banks and investigational biopharmaceuticals, bioprocess development, analytical development and bioanalytical service, aseptic fill and finish of investigational medicinal products, preclinical drug research (GLP), clinical trials phases I-II (GCP), allergy research, toxicology testing, regulatory support, registration of chemicals, biocides and pesticides
Annual Turnover · €26.4 million (2016) Request for · Collaborations concerning GMP Further Collaborations manufacture for clinical trials phase III and analytical development
Company overview As a service to clients, Fraunhofer ITEM develops biopharmaceutical manufacturing processes, performs investigations into cause-and-effect processes, develops methods and concepts for disease diagnosis and therapy, and conducts preclinical and clinical studies. All studies with drug regulatory status are performed in compliance with current GXP regulations: preclinical development is performed in compliance with GLP, clinical studies are conducted in compliance with GCP and biopharmaceutical active ingredients (APIs) and final dosage forms are manufactured in compliance with GMP requirements.
Division of pharmaceutical biotechnology The service portfolio of the Fraunhofer ITEM Division of Pharmaceutical Biotechnology covers the development of manufacturing processes for biopharmaceutical APIs such as proteins, antibodies and nucleic acids, as well as manufacture of technical batches for preclinical research. Additionally, the division transforms API manufacturing processes to comply with current Good Manufacturing Practice (GMP) requirements. For its pharmaceutical clients the division performs manufacture of APIs and investigational medicinal products (IMPs) for use in early-phase clinical trials. The division’s GMP facilities have been licensed since 1997. They are equipped with stirred-tank bioreactors of up to 400 litres volume, with technical-scale process chromatography systems and process filtration systems, enabling GMP-compliant manufacture of investigational biopharmaceutical APIs in gramme quantities. Process equipment is located in grade-D, grade-C, and grade-B clean rooms that have been EU-licensed by the regulatory agencies but meet US regulatory standards (FDA) as well. To complete the service portfolio, a clean-room unit for sterile manufacture of final dosage forms as IMPs has been GMP licensed by the regulatory authorities since 2012.
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Fraunhofer ITEM
Core elements of the GMP clean-room facilities are clean-room grade-B (class-1000) suites housing laminar flow hoods that represent class-100 work environments (clean-room grade A) for manual aseptic fill and finish operations or as restricted-access barrier system (RABS) equipped with an automatic filling machine for vials and ampoules of volumes between 1 and 20 millilitres.
Services ·· D evelopment of cell lines based on insect cells, mammalian cells (e.g. CHO), and microorganisms (e.g. E. coli) for manufacture of biopharmaceutical APIs ·· GMP manufacture (ICH Q5D) of master (MCBs) and working cell banks (WCBs) ·· GMP-compliant N2 gas-phase storage and shipment of cell banks ·· D evelopment of manufacturing processes for biopharmaceutical active ingredients based on proteins, glycoproteins/antibodies, nucleic acids/plasmids, virus-like particles, and bacteriophages ·· Validation of cultivation (USP) and purification (DSP) unit operations and processes ·· Development and validation (ICH Q2) of bioanalytical methods ·· ICH Q5C stability testing of intermediates, purified bulks, and finished IMPs ·· N on-GMP and GMP contract manufacture of biopharmaceutical active ingredients ·· Aseptic manufacture of final dosage forms as IMPs for clinical trials labelling and QP release of IMPs for clinical trials ·· GCP
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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
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.
European Biotechnology NET WORK
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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.
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Name · Genevia Technologies Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Hämeenkatu 14 C 33 33100 Tampere Finland Klaus Breitholtz (Partner, Business Development Director) Telephone · +358-40-747-7672 Email Address · klaus.breitholtz@genevia.fi Internet Website · www.genevia.fi Social Media · L I Number of Employees · 15 Founded (year) · 2011 Areas of Activity · l Bioinformatics as a Service (BaaS) l NGS data analysis l Genomics l Transcriptomics l Epigenomics l Bioinformatics consulting
Bioinformatics as a service – contract an external bioinformatics team Genevia Technologies provides bioinformatics as a service to support R&D pipelines of life sciences companies and academic institutions. Our services are focused on the analysis and integration of nextgeneration sequencing data and other omics data, such as proteomics. The main benefit our clients enjoy is the comprehensive support and full flexibility, providing the equivalent of an external bioinformatics team. Pharmaceutical, biotech, and diagnostics companies contract us to support their product development with 1. consulting for omics experiment design to ensure successful and cost-effective downstream statistical analysis, 2. custom bioinformatics pipeline development for specific needs, and 3. analysis of proprietary and public domain data sets followed by full support in interpreting, publishing, and disseminating the results.
Understand the effects of genomic variation and mutations Our genome analysis pipeline is designed to transform DNA sequencing data into concise information on inheritable and somatic genetic variation in all organisms. In order to help our clients interpret their variant data, we have developed a modular variant annotation pipeline which includes information on the variants, focusing especially on human genetics. Pathogenicity predictions, database links, and population minor allele frequencies allows effective and safe prioritisation of variants, guiding your attention to likely functional genetic events.
Study gene regulation beyond differentially expressed genes Differential gene expression analysis followed by pathway analysis allows the low cost studying, prioritising, and optimising of compounds or therapies in vitro. The same expression data enables you to create or validate hypotheses regarding lncRNAs, A-to-I editing
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GENEVIA TECHNOLOGIES
events, alternative splicing, or even mutations by side. Combining mRNA expression data with proteomics or microRNAs helps you understand regulatory networks governing altered biological processes in your system.
Decipher expression patterns with genome-wide epigenomics
BIOINFORMATICS AND SEQUENCING DATA ANALYSIS
Epigenomics aims at mapping the dynamic state of the DNA to explain transcriptomic phenomena. To this end, our epigenomic pipelines reveal transcription factor binding sites, canonical binding motifs, histone modifications, and characterisation of the chromatin state. With our DNA methylation pipelines, methylated CpG islands can be identified and annotated with information such as overlapping known promoters or enhancer regions to help in interpreting the biological meaning of these events.
Remove the bioinformatics bottleneck with dedicated professionals Our bioinformatics as a service model is designed to give you quick, effortless, and reliable access to the latest omics and bioinformatics methods to support your research where you need it most. To be able to effectively integrate with our clients’ teams, our team consists of a diverse team of bioinformaticians, data scientists, software engineers, and molecular biologists. As an important part of our service, we will also provide you with bioinformatics infrastructure and scientific and practical project management to ensure you are getting the most out of your valuable data, and deliver the results in a tight schedule so that you can meet your own deadlines. If you are interested in learning how bioinformatics can help you meet your goals, please do not hesistate to contact us.
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Name · Heidelberg Pharma AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory
· · · · · · · · · · ·
Schriesheimer Strasse 101 68526 Ladenburg Germany Professor Andreas Pahl +49-6203-1009-0 +49-6203-1009-19 info@hdpharma.com www.heidelberg-pharma.com 55 1997 (as WILEX) l Chemistry l Molecular biology l Pharmacology l Bioanalytics
Areas of Activity · l ADC technology platform l Drug research and development l Preclinical services provider External · l German Cancer Center (DKFZ) Collaborations l Heidelberg University l MD Anderson (Texas) l Takeda Pharmaceutical Company Request for · Antibodies against high tumour Further Collaborations specific antigens to conjugate with Amanitin, ADC collaborations
Heidelberg Pharma is a publicly listed, biopharmaceutical company focused on oncology. It is the first company developing the toxin Amanitin into cancer therapies, using its proprietary Antibody Targeted Amanitin Conjugates (ATAC) technology. Amanitin has a unique biological mode of action and has the potential to be used to develop 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. Almost all chemotherapy drugs used to date, including payloads of other Antibody Drug Conjugates (ADC), either function as what are known as “spindle poisons” (tubulin inhibitors) or work by binding to DNA, which makes them dependent on cell division. RNA-Polymerase II inhibition is a novel principle in cancer therapy and differs from other chemotherapeutics in its ability to kill also non-dividing cells. Amantin as a payload of ADCs offers the possibility of breaking through drug resistance or destroying dormant tumour cells, which could provide major clinical advances.
ADC technology platform This proprietary technology platform is being applied to create a variety of ATAC candidates in collaboration with third parties, as well as to develop the company’s own therapeutic ATAC pipeline. Heidelberg Pharma grants licenses to its ATAC technology for application to antibodies provided by customers. Under these license agreements, toxin linker prototypes are made available, conjugated to the customer’s antibodies, and tested biologically. Heidelberg Pharma also provides its partners technological support in the manufacture and purification of the conjugates, production and delivery of the compound, as well as the necessary preclinical research related to designing, optimising, profiling, and manufacturing new ATACs.
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Heidelberg pharma
In its product partnerships, Heidelberg Pharma provides the toxin linker technology, while its partner provides antibodies or innovative antibody formats. Together, Heidelberg Pharma and its partner will develop novel ATACs up to preclinical proof of concept. A decision will then be made with the partner to determine the best path for further development, be it joint clinical development, direct licensing by the partner, or sale of the product to another party. In addition to collaborating with partners, Heidelberg Pharma is increasingly focused on developing its own ATAC candidates. Its lead ATAC candidate HDP-101 is being prepared for clinical development, that is expected to start by the end of 2018. In a preclinical study conducted with the Heidelberg University and the German Cancer Research Center (DKFZ), non-dividing cancer cells taken from multiple myeloma patients were examined with HDP-101. A strong cytotoxic effect was observed even at low doses of HDP-101 and with low target expression on the cell surface. This is the first time that the efficacy of Amanitin on primary human cancer cells was demonstrated. Heidelberg Pharma also uses its ATAC platform to collaborate with other companies to create ATAC molecules based on antibodies from those partners.
Preclinical services business The company has the expertise and infrastructure for in vivo pharmacology and bioanalytics and offers preclinical research services in these fields for cancer, as well as inflammatory and autoimmune diseases. The company’s services are focused on early-stage research (e.g. optimisation of lead structures) up to the profiling of preclinical candidates.
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Name · Holochem Address/P.O. Box · Pharma-Parc II Voie de l’Innovation Postal Code/City · 27100 Val-de-Reuil Country · France Contact Person · Serge Calet (CEO & Founder) Telephone · +33-642-820-003 Email Address · contact@holochem.com Internet Website · www.holochem.com Social Media · I Number of Employees · 4 Founded (year) · 2017 Type of Laboratory · CRO offering chemical, process, and analytical services for the development of fine chemicals and drug substances Areas of Activity · l Impurity identification and synthesis l Reference standards characterization and synthesis l Custom and toll synthesis l Chemical development l Process development External · Holodiag: Collaborations Holochem closely collaborates with sister company Holodiag to offer integrated API contract development and manufacturing through all stages of the drug development lifecycle EuroNanoMed: Holochem partners with the NanoHeart European consortium as part of the EuroNanoMed II transnational collaborative nanomedicine projects
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Holochem is a customer-oriented contract research organization (CRO) offering chemistry manufacturing and control services for the development of fine chemicals and drug substances for the pharmaceutical chemistry, animal health, cosmetics, and agro-sciences industries. Holochem provides R&D services for the development of small and complex molecules, key intermediates, and active pharmaceutical ingredients (APIs), highly potent APIs (HPAPIs) & ADC linkers, impurities, metabolites & reference standards. We produce non-GMP pre-clinical batches from milligram to kilo-scale for early-phase formulation and toxicological use. Our custom synthesis services cover all phases of chemical development, from the design of an original synthesis pathway and the development of the industrial process, to the development and validation of the associated analytical methods. All chemistry services are integrated throughout the design process to ensure stable, scalable processes and easy technology transfer, in line with customer and regulatory requirements. All key intermediates, active ingredients, and reference substances developed by Holochem are fully EP/USP/ ICH compliant and benefit from IMPD/IND/DMP regulatory support. As part of our integrated services we can assist our pharmaceutical customers with the drafting of their regulatory files.
Chemical development Route scouting & multi-step custom synthesis Thorough understanding of project needs and constraints along with in-depth scientific expertise enable us to provide best-in-class synthetic route scouting and multi-step custom synthesis for a wide range of high-quality compounds: boronic esters & acids, boroamino acids, trifluoroborates, and many other custom compounds.
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Holochem
We have strong and solid expertise in sophisticated, exclusive synthesis and advanced chemistry technologies, including low temperature chemistry, metal catalysed coupling reactions e.g. Suzuki, organometallic chemistry, and others.
Process development, process optimisation & scale-up
Chemical development Process development Analytical development
Holochem offers full chemical process development and process optimisation services. Our scientific team has extensive knowledge of chemical process development and a deep understanding of critical process parameters and process safety concerns. We help our customers to simplify process operability and find the most efficient, stable and cost-effective way to industrialise production. Scale-up issues are anticipated throughout the design process. Our processes are reproducible and optimised for scale-up from laboratory to kilo scale, in line with customer and regulatory requirements.
Analytical development Method development & validation Holochem offers full EP/USP/ICH compliant analytical development support for drug substance and chemical development projects. Our services in the field of method development and validation involve: ·· In-process method development ·· Method development for finished APIs ·· Definition of specifications and development of monographs
Impurity identification & reference standards characterisation Our analytical development services also include the identification and characterisation of process impurities, metabolites, and reference standards. Analytical data on product quality and impurities are used to develop efficient processes and facilitate scale-up and technology transfer. We are supported by a dedicated analytical team with in-depth regulatory expertise and have access to a wide range of analytical equipment.
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Name · Holodiag Address/P.O. Box · Pharma-Parc II Voie de l’Innovation Postal Code/City · 27100 Val-de-Reuil Country · France Contact Person · Pierric Marchand (CEO & Founder) Telephone · +33-232-405-826 Email Address · contact@holodiag.com Internet Website · www.holodiag.com Social Media · I Number of Employees · 6 Founded (year) · 2006 Type of Laboratory · CRO offering pharmaceutical solid state and crystallisation services from pre-development to production Areas of Activity · l Crystallisation process development l Filtration and drying studies l Solid state screenings l Solid state analysis External · Holochem: Collaborations Holodiag closely collaborates with sister company Holochem to offer integrated API contract development and manufacturing through all stages of the drug development lifecycle Biogalenys: Holodiag and Biogalenys jointly work on several R&D projects in the field of active ingredients absorption
Holodiag is a customer-oriented contract research organization offering pharmaceutical solid state services. We support our customers with the development of the right solid phases throughout the pharmaceutical development process, from pre-development to production.
Crystallisation process development, filtration & drying Holodiag offers crystallisation process development of small organic molecules. Our main fields of operations include product recovery, yield/purity optimisation, crystallinity improvement, particle engineering, the control of solid state, and isomer separation. We have extensive expertise in enantiomer separation by crystallisation. Filtration and drying are studied as full parts of the crystallisation process. We also work on troubleshooting, robustness, and optimisation of existing processes. Crystallised samples are easier to handle, chemically purified, and generally exhibit improved stability. Our scientific team performs the development of crystallisation conditions according to the molecule’s polymorphism, solubility, supersaturation, nucleation, and growth. Strong knowledge in thermodynamics of heterogeneous equilibria and phase diagrams allows us to identify critical parameters and optimise the process with good robustness.
Solid state studies: screenings & properties investigation Holodiag performs solid state studies of small organic molecules. These studies allow us to gather knowledge on the nature of the solid states of a given compound (intermediate or API) and its related properties, and thus select the right solid phases. Reliable solid state studies are an essential prerequisite for robust crystallisation process and pharmaceutical
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Holodiag
development, as well as the elaboration of IP, patents, and regulatory files.
Crystallisation process development Solid state studies Solid state analysis
Holodiag specialises in solid state screenings, which are specific investigations into the nature of a compound’s solid states. We perform numerous experiments (1000+) on small-scale samples of a few mg, controlled by X-ray powder diffraction (XRPD), to highlight new solid states. We carry out specific screenings for polymorphs/ hydrates/solvates, salts, co-crystals, and amorphous solid dispersions. Once a solid state is highlighted, our scientists investigate its physico-chemical properties: ·· Physical stability (e.g. stable/metastable hierarchy, hydrates vs. relative humidity (RH), hygroscopicity) ·· Chemical stability (e.g. various stress conditions, temperature vs. RH) ·· Solubility, from evaluation to advanced profile ·· Dissolution (e.g. intrinsic dissolution rate (IDR), amorphous behaviour)
Solid state analysis: APIs and final formulation Holodiag offers solid state analysis services. Our laboratories are fully equipped with state-of-the-art analytical devices. Our quality system allows us to perform analyses according to GMP requirements. Each analysis is delivered with a detailed report containing all the relevant comparisons, bibliographic search, and conclusions. We conjointly provide our customers with full scientific support for data interpretation through open communication. Our in-house techniques: X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) / thermogravimetric analysis (TGA), dynamic vapour sorption (DVS), infrared (FTIR-ATR) and ultra-violet (UV) spectroscopy, polarimetry, Karl Fischer titration (KF), pH/pKa, potentiometry, and HPLC-UV. Additional techniques are readily available through our network of partners (e.g. SEM, PSD, NMR, BET). 8 th european biotechnology guide 2018
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Name · IBA GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone
· · · · ·
Rudolf-Wissell-Str. 28 37079 Göttingen Germany Dr Wolf Jockusch +49-551-50672-0 Fax · +49-551-50672-181 Email · info@iba-lifesciences.com Website · www.iba-lifesciences.com Social media · FL I G Number of Employees · ~50 Founded (year) · 1990 Type of Laboratory · S1 Areas of Activity · 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
IBA GmbH – Solutions for Life Sciences For more than two decades IBA Lifesciences develops and provides innovative solutions for your life science applications. Our portfolio includes tools for Cell Selection & Expansion, Protein Production & Assays as well as Custom Oligos & Predefined DNA/RNA.
Product portfolio Cell selection & expansion Fab-TACS® technology ensures automated cell selection directly from whole blood employing IBA’s design awardwinning FABian® device. Customised protocols depending on cell type, sample volume, and 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. For convenient manual cell selection we offer Fab-TACS® Gravity columns. 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 StrepTactin ®XT and Twin-Strep-tag ®. Strep-Tactin ®XT is a further developed Strep-Tactin® with extra high affinity to Twin-Strep-tag®, which now enables the use of the Strep-tag® technology in applications where high affinity 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.
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IBA
screening of new diagnostic targets and the development of diagnostic assays. 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 and diagnostics ·· Serving international markets directly and through a network of distributors
People Dr Mike Rothe (Chief Executive Officer) Dr Joachim Bertram (Chief Scientific Officer) Dr Herbert Stadler (Head of the Advisory Board)
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Name · Indivumed GmbH Address/P.O. Box Postal Code/City Country Contact Persons
· · · ·
Telephone Fax Email Website Number of Employees Founded (year) Type of Laboratory Areas of Activity
· · · · · · · ·
Falkenried 88 – Bldg. D 20251 Hamburg Germany Prof. Dr Hartmut Juhl (CEO) Andrew Deubler (CBO) +49-40-4133-83-0 +49-40-4133-83-14 info@indivumed.com www.indivumed.com 140 2002 L2, S1 Cancer Research and Development; Highly standardized collection; banking and processing of human biospecimens and patient data; prospective collection of clinical samples; clinical trial support; drug target and biomarker identification and validation services; drug profiling in human primary tumor explants; discovery of proprietary biomarkers and phosphoprotein profiling.
Biological Patents · INDIVUMED has been granted three patents relating to cancer biomarkers and their use in diagnostics. External · INDIVUMED has developed a unique Collaborations collaborative network with leading cancer clinics in Germany, India, Poland and the US, as well as with biopharmaceutical companies and academic institutions worldwide, including the US National Cancer Institute. Request for · INDIVUMED intends to enter into Further Collaborations strategic collaborations with industry partners for the joint development of cancer diagnostics and therapeutics.
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Company overview Indivumed, an ISO-certified global oncology research company based in Hamburg, Germany, has established the world’s leading cancer database and biobank, retaining unique patterns of biomolecules such as RNA, DNA, and proteins as they existed in the human body. This cancer database makes multi-omics capabilities possible that will allow for characterization of samples and data such as whole genome gene expression analysis, expression analysis of cancer-relevant proteins, expression analysis of cancer-relevant phosphoproteins and bioinformatic solutions for integrating molecular, biological, and clinical information. Indivumed’s products and services allow for in-depth understanding of the underlying mechanisms of a patient’s cancer, addressing important demands in translational research and molecular diagnostics to support implementation of personalized health care.
Preclinical and clinical services INDIVUMED has established an outstanding, high-quality ISO 9001:2008 certified global biobank and data collection comprising more than 24,000 patient cases and an infrastructure of proprietary clinical and laboratory facilities. Accurate follow-up information and additional post-surgery samples are obtained on a regular basis. INDIVUMED enables the highest quality drug target and biomarker identification and validation by combining its biospecimen and clinical data collections with state-ofthe-art analysis technologies.
Laboratory services Immunohistochemistry INDIVUMED establishes highly validated immunohistochemical assays for antibody, target, and biomarker validation in a GCP-compliant environment. Standardised and reproducible staining procedures with the automated Ventana Discovery® XT or BenchMark staining platforms lead to excellent results for INDIVUMED’s customers. By also providing full histopathology evaluations using its in-house pathologists, Indivumed is able to realise a complete service portfolio for its clients as well as the pharmaceutical and biotech industries.
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Indivumed
Phosphoprotein profiling INDIVUMED analyses phosphoproteins using the automated proteomic platforms Meso Scale Discovery (MSDÂŽ) and Simple Western Technology (Peggy SueTM and NanoProTM 1000). These technologies are capable of distinguishing between total and phosphorylated states of proteins from a huge variety of commercially available targets in oncology and other research fields.
Biobank products Ischemia time-controlled biospecimens For more than 15 years, INDIVUMED has been collecting the highest quality biospecimens through its own study nurses according to strictly enforced operating procedures. The routine collection of fully consented highquality tumour and matched normal tissues and fluids (frozen or formalin fixed, serum, plasma, PBMCs and urine) and guaranteed short ischemia times (on average 10 min) enable the investigation of the molecular realities of gene and (phospho-) protein expression patterns.
Management team Prof. Dr Hartmut Juhl Andrew M. Deubler Michael Gutsmann Gudrun Niewel Dr Heinz Joachim List Dr Hans Vanhooren Kevin Sullivan Frank Clausen
Leonidas D. Leondaridis Dr Frauke Kristin Koch Dr Nina Gabelia PD Dr. Kerstin A. David Dr Bernd Gromoll Dr Philipp C. Uhlig Antje Schmitt Dr med. Ronald Carter
Financing INDIVUMED generates revenue through the commercialisation of its products and services. It has been awarded several public grants and has received funds from private investors.
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Name · Infrapark Baselland AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Number of Employees Founded (year)
· · · · · · · · · ·
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 190 2011
Areas of Activity · Chemical park
Infrapark Baselland AG offers 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 either in the production and development of specialty chemicals or in providing special services to this industry 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 of life sciences and biotech industries and research institutes Thanks to the network of Infrapark, companies located in our chemical park can tap into an unrivalled life sciences/biotech talent pool. The Basel area is home to world-famous 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, and Bachem, as well as promising biotech start-up companies.
Real estate offer of Infrapark Infrapark provides the chemical and life sciences industry with 32 hectares of outstanding developed real estate. In addition to existing buildings, which can be converted to meet actual demand, around 5 hectares of free plots are available to interested companies.
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Infrapark baselland
Custom-tailored services To allow customers of Infrapark to concentrate on their core business activities, we offer a comprehensive range of services: ·· Facility Management ·· Utilities (energy products and resources) ·· Waste Disposal (incineration of solid, liquid and also gaseous waste, including source exhaust air and unique waste water pretreatment) ·· Health, Safety, and Environment: Experts provide solutions-led advice to our customers for their individual projects, as well as supporting 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
Speed According to our customers, one of the decisive factors in locating their enterprise at Infrapark site Muttenz is the speed with which they can realise their business, be it the permit to start with the construction work of a production building or the permit to start manufacturing chemical products. Compared to other European locations, the authorities show a professional approach in dealing with special requests and are very familiar with the processes in the chemical and pharmaceutical industry.
> Analytical Services > Logistics > Health, Safety, and Enrivonment > Engineering > Workshops
Infrapark: home for the chemical, pharmaceutical, and biotech industry Infrapark Baselland offer all the advantages of a chemical park: services from a single source that allow our customers to focus on their core competencies. And our location is ideal: hardly any other region in the world demonstrates a comparable concentration of industrial companies and research institutions 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. 8 th european biotechnology guide 2018
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innovating vaccines
Name · Intravacc Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Telephone Email Address Internet Website Number of Employees Type of Laboratory
· · · · ·
Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven The Netherlands Dr Ivo Ploemen (Business Development Manager) +31-30-7920300 businessdevelopment@intravacc.nl www.intravacc.nl 150 ML-II BSL-2 BSL-3
Areas of Activity · l Vaccine development l Process and assay development l Animal models l (Pilot) Production, QC & QA l Clinical and regulatory affairs External · l Academia Collaborations l Public health organisations (WHO, BMGF) l Biotech and pharmaceutical companies
Intravacc 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. Intravacc reduces the risks and costs involved with developing vaccines by bridging the gap between concept and late-stage clinical studies.
Viral vaccine technology For new viral vaccine development, we use established blue-prints and scalable platform production processes, including those based on an available scale-down process for IPV. Our proven technologies are based on Intravacc’s long-standing experience with oral and inactivated poliovirus vaccines and include virus seed strains recovery from synthetic viral genomes, cell and virus culture technology, virus harvest and clarification, purification, formulation, and freeze-drying, with all analytical assays required for in-process controls and product release. Our viral vaccine platform makes use of Intravacc’s established WHO pre-qualified Vero cell line. In this way, we can demonstrate fast-track proof-ofprinciple of a pilot process for various viral vaccines, as recently shown for Sabin-IPV, OPV, RSV, EV71, CVA16, and Rota vaccine concepts, using a science-based quality-by-design approach.
Bacterial vaccine technology For the development of vaccines against bacterial pathogens, Intravacc has designed and developed, in addition to conjugate vaccine technologies, a unique platform based on outer membrane vesicles (OMVs) – 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, are difficult to cultivate, or contain viral and/or parasitic proteins. The antigens of choice are placed in an “empty” OMV. We have developed genetic tools to increase yield, reduce toxicity, and achieve the desired antigenic com-
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position. A robust, scalable GMP production process is operational.
Bridging the vaccine development gap DISCOVERY
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
LICENSURE
Vaccine design
Process & Assay Development, Scale-up
Research Animal Models
Pilot-scale Production, Quality Control & Quality Assurance Clinical & Regulatory
Intravacc Co-Development with partners
Our broad technological capabilities including (physico) chemical analyses, molecular biology, proteomics, immunological read-out, and mass spectrometry allow us to guide your innovative vaccine concept through the development chain. Advanced LC-MS analysis allows us to provide state-of-the-art knowledge and know-how in protein characterisation. As a front-runner in applied research on mucosal and intradermal delivery we can create value for promising delivery technologies. Our formulation team can help to produce safe, affordable vaccines by using the right excipients. 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 laboratory facilities for housing different species of experimental animals, e.g. (transgenic) mice, rats, cotton rats, ferrets, guinea pigs, and rabbits. Moreover, 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). You can find more information on www.intravacc.nl.
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Name · IRBM 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 Pontina Km 30,600 00071 Pomezia (RM) Italy Pier Giorgio Pacifici, PhD (Business Development Manager) +39-06-91093-692 +39-06-91093-654 bd@irbm.it www.irbm.it
· · · · · I · 250 · 2009 · l Chemical l Biological l NMR l Animal facility l Analytical l Prep lab (Kg-scale, non GMP) l BSL 1, 2, 2+ Areas of Activity · Integrated drug discovery (screening to preclinical candidate selection), individual drug discovery services External · We are working on collaborations with Collaborations several of the top-10 pharmaceutical companies worldwide, in addition to medium-sized, and small pharma and biotech companies, research institutes, and multiple non-profit foundations.
Request for · Contact us to learn more about how Further Collaborations our experienced drug hunters, exMerck scientists responsible for 4 drugs now on the market, can help support your R&D efforts in a costeffective way while mitigating risk and identifying novel solutions to overcome difficult challenges.
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We are a privately-owned drug discovery group, rooted in scientific success. Our history begins in 1990, as a joint venture between MSD and Sigma Tau. In 2000, we became a full site for MSD, and in 2009 we reorganised into an independent company. Scientific excellence is in our DNA. Our team invented and worked on 4 drugs on the market, including ISENTRESS® (a first-in-class HIV integrase inhibitor), ZOLINZA® (the first HDAC inhibitor for non-small cell lung cancer), Grazoprevir (ZEPATIER® for HCV), and ZEJULA® (a PARP inhibitor for ovarian cancer). We have delivered over 25 preclinical candidates, and published hundreds of papers. We understand how challenging drug discovery can be. With more competition, companies must generate a pipeline of strong candidates. To mitigate risk and ensure swift progress from discovery to clinic, projects require great scientific expertise, state-of-the-art facilities and significant resources. At IRBM, we accelerate your pipeline up to drug candidate status. Through our scientific expertise, providing insights and the highest quality standards, we advance your project swiftly and cost-effectively without compromising on quality. We are your Partner Research Organisation.
Our capabilities We contribute scientifically to your projects, ensuring your peace of mind. We aim to become fully integrated in your R&D, deploying a powerful R&D engine for your projects. Many of our researchers have been with us for 15+ years, and their experience in “Big Pharma”-like problem solving ensures quick advancement while applying risk mitigation strategies. We focus on seamlessly integrated discovery and preclinical development of small molecules, therapeutic peptides, and biologics. Focus therapeutic areas include, among others, neurodegeneration, oncology, and infectious diseases.
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IRBM
·· Assay Development: primary and secondary cell- or target-based assays; ultrasensitive biomarker assay development/validation; photon-based or label-free detection technology. ·· High-Throughput Screening: automated workflow; curated collection of 350,000 compounds; partner collection hosting; virtual and pilot screening capabilities, NMR-driven fragment-based approaches, preliminary SAR acquisition; kinetic/thermodynamic binding studies. ·· Medicinal Chemistry: HTS follow-up/clustering; computer-aided drug design; pharmacophore modelling; multi-dimensional optimisation of drug-like properties; complex synthesis, purification and analytical capabilities; scale-up production. ·· Peptide Chemistr y: synthesis of long peptides (>200aa); large collection of proprietary, exotic amino acids; chemoselective conjugations; PK-enhancing approaches; combinatorial peptide libraries; structure-driven targeted libraries; evaluation of anaphylactic potential. ·· Biochemistry: proprietary phage display libraries; biologics conjugation; capabilities to build thirdparty antibody or peptide libraries; protein production and characterisation. ·· Pharmacology and Preclinical Research: in vitro cell biology models and assays; PK in preclinical species; drug-drug interactions; metabolite ID; oral absorption and first-pass extraction; plasma protein binding; human PK prediction; blood-brain barrier penetration studies; NMR support; ADME and DMPK optimization. Advent, our FDA- and EMA-accredited cGMP CMO facility, manufactures novel investigational biologics, such as adenovirus-based vaccines and gene therapy products. We have offices on the campus of the San Raffaele hospital in Milan, with access to cutting-edge science, clinical samples, and key opinion leaders. And we push Italian innovation through a public-private consortium, CNCCS, with the Italian National Research Council (CNR) and the Istituto Superiore di Sanità (ISS), to expedite innovative projects. 8 th european biotechnology guide 2018
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Name · ITM – Isotopen Technologien Muenchen 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
· · · ·
Lichtenbergstrasse 1 85748 Garching Germany Nicola Scharrer (Head of Marketing) +49-89-329-8986-60 +49-89-329-8986-66 info@itm.ag www.itm.ag
· · · · · LI · 105 · 2004 · Radiopharmaceutical Company
Areas of Activity · l Oncology l Targeted Radionuclide Therapy l Nuclear Medicine
Targeted cancer diagnostics and therapies ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production, and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of a novel, first-in-class radionuclides and -generator platform for a new generation of targeted cancer diagnostics and therapies. ITM’s isotope business is profitable and growing. In July 2016 the European Commission granted marketing authorisation for EndolucinBeta® of ITM’s subsidiary ITG Isotope Technologies Garching GmbH. EndolucinBeta® respectively no-carrier-added (n.c.a.) Lutetium (177Lu) chloride is a radiopharmaceutical precursor and is used in Targeted Radionuclide Therapy. The drug approval is an important milestone for ITM as a specialised radiopharmaceutical company. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers, such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical, and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. ITM Isotopen Technologien München AG was founded in 2004 and is the holding company for its subsidiaries ITG Isotopes Technologies Garching GmbH, ITM P4 Diagnostics GmbH, and ITM Oncologics GmbH. ITM is privately held and is responsible for the management and administration of its wholly-owned subsidiaries, together with the administration of IP.
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ITM
Since 2007 the name ITG Isotopes Technologies Garching GmbH has stood for the highest level of quality and reliability in the sourcing, processing, radiolabeling, and sale of radionuclides and for the marketing of devices. ITG’s unrivaled logistics network allows guaranteed shipment within 24 hrs (Europe) and 72 hrs (overseas) respectively. ITM Oncologics develops innovative product candidates in the field of Targeted Radionuclide Therapy in Precision Oncology. It aims to identify, either independently or in collaboration with partners, appropriate targets and targeting molecules, and to link these with radionuclides for cancer therapy. ITM Oncologics has a number of very interesting candidates in the early clinical or pre-clinical phase, for example in the field of bone metastasis. Our lead product Solucin® recently started a phase III clinical trial, known as COMPETE. COMPETE is an international pivotal multi-center Phase III clinical trial evaluating the efficacy and safety of n.c.a.177Lu-Edotreotide (Solucin®) compared to Everolimus in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The subsidiary ITM P4 Diagnostics connects ITM Oncologics with the development of next-generation precision diagnostics based on a proprietary biomolecule portfolio and the genetic fingerprints of targeted tumours. For more information about ITM, please visit: www.itm.ag
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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
90 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 Prioritisation & Immune Collaborations Monitoring (BioNTech AG), The Human Proteome Peptide Library (TU Munich), Cancer Proteomics (MSKCC), Deep Viral Pathogen Detection (FriedrichLoeffler-Institute) 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
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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
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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. 8 th european biotechnology guide 2018
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Name · Labor Dr. Merk & Kollegen GmbH Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Founded (year) Type of Laboratory
· · · · · · · · · ·
Beim Braunland 1 88416 Ochsenhausen Germany Dr Ingrid Rapp +49-7352-911930 +49-7352-911940 info@labormerk.de www.labormerk.de 1971 S2
Areas of Activity · l Process development l GMP manufacturing of viral therapeutics l Biosafety testing in virology and microbiology l Cell-based assays l Analytics
Excellence in virology Labor Dr. Merk & Kollegen GmbH (LMK), GMP and GLP certified, is a centre of excellence for virology, pioneering viral characterisation, MVB and WVB establishment, raw material testing, microbial and viral disinfectants testing, cyto-toxicity testing, vaccine release testing, and viral clearance studies, with more than 40 different high titre purified viruses from animal and human origin available.
History Founded in 1971, LMK is a family-owned company based in Ochsenhausen, Germany with more than 60 employees with outstanding expertise, training, and specialisation in virology, with EMA approval for release testing of vaccines produced outside of Europe, serving the health and welfare of our global population.
Viral therapeutics LMK offers process development and GMP manufacturing of viral gene therapeutics and oncolytic viral therapeutics as well as vaccines. LMK operates as a full CDMO with end-to-end process development, manufacturing of drug substances and drug products with analytical characterisation, and regulatory support.
Upstream processing For manufacturing of a broad range of viral therapeutics such as adenoviruses, adeno-associated viruses, lentiviruses, VSV, and parapox viruses, LMK has established adherent cell technologies in T-flasks, cell factories, and iCELLis, and suspension cell culture technologies with chemically defined media, and feeding systems in SUB. LMK also has the expertise to convert adherent processes to safer and simpler scalable suspension processes up to BSL-2. LMK performs MCB and WCB of a broad range of cell lines suitable for viral propagation and has an extended media screening programme for cell line growth and virus titre performance. Harvest systems by depth filtration are available, as well as cell disruption for release of viruses, if required.
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Downstream processing In downstream processes LMK operates AIEX and CIEX chromatography as well as adsorber membranes, allowing separation of full and empty capsids as well as affinity chromatography for capturing viruses from cell culture fluid in high purity, low HCP content, high titre, and high yield. For formulation LMK offers thermo-stable formulations for viral therapeutics as well as fill & finish in liquid or lyophilised form up to BSL-2. Stability testing is performed according to ICH guidelines. All processes are scalable for industrial manufacturing for clinical supply by LMK.
Analytics LMK offers a broad spectrum of analytical methods for determining purity, efficiency, and safety of viral therapeutics and vaccines, including a variety of bio- and cell-based assays. This also includes but is not limited to the determination of empty and full capsids, infectious and genomic virus particles, and virus aggregates.
CRO/CDMO business Customers of LMK range from biotech startup companies to Big Pharma. LMK has collaborations with academia to improve their state-of-the-art technologies, including universities in Aachen, Biberach, Hannover, Tübingen, Ulm, and Vienna.
LMK as end-to-end CDMO ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··
MCB/WCB MVB/WVB Adherent and suspension cell screening Media optimization MOI optimization Innovative process development GMP manufacturing of DS and DP Formulation development Analytical characterisation Regulatory support Compliance with relevant guidelines
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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) Areas of Activity
· · · · · · · · · · · ·
C/ Pallars 179–85 08005 Barcelona Spain Izabel Alfany, PhD +34-93-78823-00 +34-93-78919-06 international@leitat.org www.leitat.org
F IV 250 1906 Oncology, health and wellbeing, nutrition, cosmetics, skin biology, toxicology (nano), toxicological risk assessment, biocatalyasis, bioprocess, biofilm, waste valorisation, biopolymers.
Annual Turnover · h17 million Biological Patents · WO2011157724A1; WO2014167030; WO2012098124A1 External · University College London, Karolinska Collaborations Institutet, Allmirall, B Braun, CEA Leti, Pluristem, Fraunhofer, Philips, Oryzon, BASF, Nestle, VTT, GE Healthcare. Request for · LEITAT acts as a technological partner Further Collaborations by signing collaboration agreements to join efforts to meet the industrial technology challenges set out and promoting enterprising capacity and by technology transfer. Moreover, LEITAT has wide experience with EU projects and looks forward to building up new collaborations for H2020 framework projects.
Member of
LEITAT is a technological centre specialised in the production of technologies, developing R&D activities in the areas of materials sciences, environment, biotechnologies, 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 regional and national governments, and in others co-funded by the European Commission, and develops private R&D projects funded by industrial partners. LEITAT has 5 Business Units: Health & Medicine, Applied Chemistry & Materials, Energy & Engineering, and Circular Economy. Herein we highlight the main expertise related to Biotechnologies:
Health & Biomedicine unit The Health & Biomedicine Unit (H&B) has more than fifteen years of previous experience with preclinical investigation in oncology in a multinational pharmaceutical concern. Highlighted research lines: ·· Generation of polyclonal and monoclonal antibodies (mAb) on demand for basic research, diagnosis and therapeutic treatments. ·· Genetic engineering of proteins and monoclonal antibodies. ·· In vitro cellular models to study efficacy, security, action mechanisms, metabolomics (…) of drugs, cosmetics, food etc. ·· In vivo animal models to study efficacy, biodistribution, pre-tox, etc. (oncology, inflammation, dermatology, sports, cellular and tissue regeneration, angiogenesis.) ·· In vivo animal models to study microbioma, disbiosis, and human microbiota transplants. ·· Design of biogenetic tools for the validation of therapeutic targets and diagnostic biomarkers.
European Biotechnology NET WORK
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Circular Economy unit The Circular Economy unit (CE) offers innovative technologies and strategies for the efficient management of natural resources, sustainable production, and the optimal treatment and valorisation of residual streams. Main research areas are: ·· Waste management and valorisation: biomass, industrial & municipal wastes/byproducts. ·· Water treatment & reuse: industrial & municipal waters. ·· Air treatment & control: indoor & outdoor environments. ·· Biotechnologies: greener products & processes. ·· Sustainability: life cycle sssessment, communication & responsibility, sustainable production.
Applied chemistry and materials unit The Applied Chemistry and Materials unit (ACM) aims to develop new products and processes for the industry along the entire value chain of chemistry and materials. The highlighted research lines are: ·· Raw Materials: study and synthesis of (bio)polymers, resins, etc. Synthesis and surface modification of metallic and ceramic nanomaterials, among others. ·· Design and formulation: paints, inks, functional coatings, products of detergency, and cosmetics. Development of polymeric composites. ·· Processing and application: transformation of polymers through conventional techniques. Spinning processes. ·· Validation & characterisation of materials.
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Name · Lipotype 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
· · · · · · · · · · · ·
Tatzberg 47 01307 Dresden Germany Dr Oliver Uecke +49-351-796-5345 +49-351-796-5349 sales@lipotype.com www.lipotype.com
FL I 12 2012 Analytical laboratory
Areas of Activity · l Lipidomics l Lipid analysis for Biotech and Pharma l Clinical research l Academic research l Food industry l Cosmetics industry
Lipotype is a spin-off company from the Kai Simons and Andrej Shevchenko labs of the world-renowned MaxPlanck-Institute of Molecular Cell Biology and Genetics in Dresden, Germany. Drawing on many years of cuttingedge research experience, Lipotype delivers comprehensive, absolutely quantitative lipid analysis services for clinical and biological samples on a high-throughput scale. Lipotype offers high-quality lipid analysis services for a wide range of customers and applications including biomarker identification for clinical researchers, Pharma and Biotech companies, functional food development for the food industry, and claim support for the cosmetics industry, as well as for the small-scale profiling needs of academic researchers.
Customers and applications · Biotech and Pharma industry, clinical research – Drug discovery (mode-of-action studies, target validation, effect of delivery system on lipid metabolism), biomarker identification (pharmacodynamic, pharmacokinetic, CDx), clinical screening, and diagnostics · Food industry – Intervention studies for development of functional food/nutraceuticals · Cosmetics and Dermatology – Cosmetic claim support, topical drug development, development of personalised cosmetics · Academic research –Lipid analysis of various model organisms
Advantages of Lipotype Shotgun Lipidomics – Ultra-broad coverage The Lipotype Shotgun Lipidomics platform provides a broad coverage of membrane lipids, but also of storage lipids. Our analysis routinely covers 30 different lipid classes (e.g. TAG or PC) on the level of lipid species (e.g. TAG 54:0) or subspecies (e.g. PC 18:0/16:0, including the fatty acid information) – in total more than 2300 individual lipids.
Full high-throughput Lipotype uses Shotgun Lipidomics Technology without time-consuming chromatographic separation of lipids before analysis. We utilise the advantages of cuttingedge mass spectrometry, combined with automated
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sample extraction, processing, and data analysis. In this way our exquisitely standardised platform allows the analysis of 200 plasma samples per day, offering unprecedented delivery time for complete results and associated reports.
Absolute quantification The quantification is achieved using lipid class-specific internal standards allowing unbiased and direct quantitation of individual lipids directly from their mass spectra intensities. Therefore, we deliver results expressed in absolute and not in relative values, which provides the basis for a direct comparison of different samples and experiments.
Highest quality Lipotype’s Shotgun Lipidomics Technology is highly robust and reproducible. This performance is ensured by a rigorous quality control system. The high standards of Lipotype operations are based on years of research experience on the role of lipids in cellular processes and on the development of lipidomics technology according to industry requirements.
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Summary of Lipotype Shotgun Lipidomics · Global lipidomics with coverage of more than 2,300 individual lipids in 30 different lipid classes · Absolute quantitation of lipids · Worldwide only lipidomics platform for which intersite reproducibility and full validation could be shown (Surma et al. 2015) · Robust technology with technical variation < 10 % · High-Throughput allows data delivery within 2 weeks · Minimal sample amount needed · Identification of lipids at the structural level of lipid subspecies · Extensive know-how in data mining, machine learning, and multifactorial regression analyses for identification and interpretation of lipid biomarkers · Proven experience with various sample types from body fluids, organelles to organs
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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 deliver
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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 2018: The 14th Legal Affairs Conference held on 25 April in London will be an opportunity to discuss with leading industry executives and experts, counsel and European institution officials the latest developments in intellectual property and legal affairs concerning generic, biosimilar and value added medicines in Europe and worldwide. On 26 & 27 April 2018, London will host the 16th Biosimilar Medicines conference. This year’s flagship event will gather top EU and global regulators, officials, healthcare actors as well as industry leaders, to foster open exchange and debate on the role of the biosimilar medicines sector in “Biosimilar Medicines: Unlocking the Full Potential of Biologics”. Over two days, participants will dive into a dynamic programme – a crossroads between technical, scientific, market discussions and the overarching healthcare policy agenda. With 15 years of experience-sharing on scientific assessment, regulatory approval and the introduction of biosimilar medicines in clinical practice, this conference will take us to new uncharted waters in preparing for this new era. Biosimilar medicines have been game changers in the therapeutic areas where they have been used (e.g. rheumatology, gastroenterology) with positive benefits on access to treatment, and therefore on patient outcomes. The Joint 24th Medicines for Europe and 21st IGBA Annual Conference will bring together 250 experts including medicine manufacturers, stakeholders and governments to evaluate market trends, innovative commercial strategies, challenges for the pharmaceutical sector and new opportunities to improve access to medicines for patients. At this unique event, the participants will not only gain new information, but will also have the opportunity to network in the beautiful capital of Hungary, Budapest! 8 th european biotechnology guide 2018
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Name · Microsaic Systems Address/P.O. Box · GMS House Boundary Road Woking Postal Code/City · GU21 5BX Surrey Country · United Kingdom Contact Person · Glenn Tracey Telephone · +44-1483-751577 Email Address · info@microsaic.com Internet Website · www.microsaic.com Social Media · L I Number of Employees · 20+ Founded (year) · 2001 Areas of Activity · l Mass spectrometry l Real-time point-of-need analysis l Product characterisation l Quality-by-Design strategy l Biopharmaceutical process control
Microsaic Systems plc (AIM: MSYS) develops point-ofneed mass spectrometry (MS) detection for biopharma, bioprocessing, and process analytical technology.
Miniaturised MS technology for point-of-need analysis Using micro-engineering principles, Microsaic is the first to miniaturise mass spectrometry for point-ofneed use. This reduces MS into a single box, while still delivering powerful analytical performance. Our patented chip-based technology enables analytical detection and characterisation where and when it is required, for a broad range of on-line, at-line, and offline applications. Easy to use, with no prior knowledge of MS required, our technology gives users and process operators access to continuous MS detection data at any step in their workflow.
Reaction monitoring An essential part of an efficient Quality-by-Design (QbD) strategy, adding point-of-need MS to a bioprocessing environment allows the user to promptly characterise important critical quality attributes (CQA) of the biologic products, and monitor critical process parameters (CPP) within the bioprocess itself. This enables timely decisions to be made about how best to intervene in the workflow in real-time. As a result, our miniaturised MS system safeguards the biologics manufacturing process so that the product is of the desired quality and type, which can ultimately lead to a more robust yet agile biologics processing and manufacturing. Our systems can interface with a whole range of equipment ranging from LPLC, LC, preparative chromatography, and more direct introduction methods from your workflow. We also support general analytical interfaces with TLC, CE, and Nano-LC.
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Work with us We are working on a number of collaborations to further develop and broaden the commercial applications of our real-time MS solutions. Collaborators can work with us on a broad spectrum of workflow elucidation, as our capabilities range from the detection and characterisation of large proteins (for example intact monoclonal antibodies), through to small biologics (such as insulin), or to monitoring specific CQA parameters such as glycosylation. In addition, our systems can check important nutrients, metabolites, and other smaller molecules in the cell media, which can be used for monitoring critical process parameters (CPP). Our expertise is in the development, integration, and application of chip-based MS technology and we are always interested in hearing new ideas or in potential collaborations and partnerships. Contact us via info@microsaic.com to start the dialogue.
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Name · Microsynth AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Websites
· · · · · · · ·
Founded (year) · Number of Employees · Type of Laboratory ·
Areas of Activity ·
Schützenstrase 15 9436 Balgach Switzerland Christof Wunderlin +41-722-83-33 +41-71-722-87-58 info@microsynth.ch www.microsynth.ch www.microsynth.seqlab.de www.microsynth.at www.ecogenics.ch 1989 >80 ISO/IEC 17025:2005 accredited labs (NGS, Sanger, paternity testing) and GMP certified labs (Sanger) 1. Synthesis of DNA/RNA oligonucleotides 2. DNA sequencing (Sanger, NGS), DNA/RNA isolation, qPCR and genotyping analyses 3. Contract research/outsourcing
Request for · New development and outsourcing Further Collaborations partnerships with both industry and academia where our expertise in molecular biology, project management and automation can be applied.
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. Microsynth has subsidiaries in Germany (Microsynth Seqlab), Austria (Microsynth Austria) and Switzerland (ecogenics) and serves more than 15,000 customers worldwide.
Products & services 1. Synthesis of DNA/RNA Oligonucleotides ·· DNA and RNA oligos for various research purposes (various scales, modifications and purifications) ·· Antisense oligos with drug-like properties (e.g. 2’ MOE gapmers) for drug discovery ·· DNA oligos for molecular diagnostic applications
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·· Pilot scale synthesis for up to gram quantities of DNA/RNA oligos ·· Primers for NGS applications (e.g. Illumina primers) 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 ·· NGS sequencing & bioinformatics with focus on ·· Small genome sequencing ·· Eukaryotic model organism re-sequencing ·· Transcriptome analysis (e.g. RNA-Seq) ·· Amplicon deep sequencing (e.g. CRISPR/Cas9) ·· Metagenomics sequencing (16S/ITS, shotgun) ·· Whole exome sequencing ·· PCR, qPCR and digital PCR assay development and testing ·· Food testing (species, allergens, GMOs etc.) ·· Vet. med. applications (e.g. eradication of BVD) ·· Gene expression, CNV and SNP detection ·· Genotyping of plants and animals (e.g. GBS) ·· Paternity 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 projects (Basic research · Discovery · Preclinical phase · Clinical development · Quality control in manufacturing).
Management and personnel Dr Tobias Schmidheini (Chairman of the Board) Dr Markus Schmid, Christof Wunderlin (Co-CEOs Microsynth AG) 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 holds a PhD). Our specific expertise, in combination with our mission, makes us a qualified and reliable partner for empowering molecular biology research. 8 th european biotechnology guide 2018
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Name · MOLOGEN AG Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet 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 ~50 1998 Clinical drug development in the areas of cancer and infectious diseases
Annual Turnover · +/- €0 Relevant R&D Budget · €17 million (FY 2016) Biological Patents · Comprehensive international patent protection for our product candidates External · l ONCOLOGIE Inc., USA Collaborations l Aarhus University Hospital, Denmark l The University of Texas MD Anderson Cancer Center, USA Request for · Partnering opportunities for our Further Collaborations compounds
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 compound 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 the immunotherapeutic agent lefitolimod, and its follow-up molecules EnanDIM ®. Lefitolimod is the company’s lead compound and regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this action mechanism, lefitolimod is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Furthermore, it had been investigated in a phase II IMPULSE study in small cell lung cancer and an exten-
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sion phase I study in HIV, called TEACH. Key results of these studies were announced in April and August 2017. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®) in various cancer indications.
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.
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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
· · · · · · · · · · ·
Im Neuenheimer Feld 515 69120 Heidelberg Germany Dr Christian Roesky +49-6221-502590 +49-6221-5025921 info@novaliq.com www.novaliq.com 60 2007 l Chemical l Pharmaceutical
Areas of Activity · l Specialty pharma l Ophthalmology l Drug delivery Biological Patents · 29 patent families with a total of 76 patents issued for all key pharmaceutical markets External · l University of Cologne Collaborations l Queens University Belfast l University of Auckland l Martin-Luther University Halle Request for · With its fast and proven drug Further Collaborations development process and its rich pipeline of differentiated products, Novaliq provides a unique opportunity for industry and academic partners.
The organisation Novaliq GmbH is a specialty pharmaceutical company focused on developing innovative products for ophthalmic indications. Founded in 2007 and based in Heidelberg, Germany, Novaliq develops first- and best-in-class ocular therapeutics based on EyeSol®, its disruptive water-free drug delivery technology.
Business strategy Novaliq’s mission is to transform Active Pharmaceutical Ingredients (APIs) into highly effective ocular therapeutics for both the front and the back of the eye. All product developments are based on Novaliq’s proprietary, water-free drug delivery technology called EyeSol®.
Mechanisms of action and technology EyeSol® is the first and only technology to overcome the limitations of water-based eye drops, creating novel drugs with added value such as better bioavailability, efficacy, stability, and tolerability. EyeSol® is clinically validated by several NovaTears® and CyclASol® trials.
Product pipeline Novaliq offers an industry leading pipeline in DED. CyclASol®, Novaliq’s most advanced DED pipeline product, has demonstrated better efficacy and tolerability versus current gold-standard Restasis® in a Phase 2 trial.
NovaTears® Novaliq’s first commercial product, NovaTears®, is on the market in selected European countries for the treatment of dry eye disease (DED). NovaTears ® is a first-in-class, preservative-free eye lubricant and tear film stabiliser for evaporative dry eye disease. As the first of its kind, NovaTears® offers a new Mode of Action by acting as a lubricating lipid layer and evaporative barrier for improved tear film.
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NovaTears® is clinically validated by significant improvement in signs and symptoms in evaporative dry eye disease and MGD patients (NT-001 and NT-002). It is approved and marketed in Europe under the brand name EvoTears® by Ursapharm.
NovaTears®+Omega-3 NovaTears®+Omega-3 are the first eye drops containing Omega-3 in a multi-dose bottle. The product is the first water-free lipid layer stabilizer containing Omega-3 fatty acids. NovaTears ® efficacy and safety have been clinically validated by 4 prospective, post-market studies.
CyclASol® A pivotal-stage, anti-inflammatory drug to treat Dry Eye Disease (DED) CyclASol ® is a promising candidate with significant improvement in signs with earlier onset of action vs. the market gold standard in moderate/severe DED being in a pivotal US trial in 2017/18. Cyclosporine A has been proven to be the most successful API for the treatment of dry eye disease in the United States so far. In January 2017, Novaliq announced positive Phase 2 results evaluating CyclASol ® in 207 patients with moderate to severe dry eye disease (DED). The reported data confirmed that CyclASol® had demonstrated a superior outcome and an early onset of action when compared head-to-head with Restasis™.
Management Dr. Christian Roesky (CEO) Dr. Oliver Schlüter (CFO)
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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
The company NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, and training 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.
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M Global
Rach Exec
NSF International
·· 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. ·· 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! ·· Auditor certification. We will independently “certify” your GMP auditors so you can be confident of their findings. ·· Investigation and CAPA system assessment and training.
Why choose NSF’s pharma biotech services?
MEET OUR TEAM
Martin Lush Global Vice President
Mike Halliday Executive Vice President
John Johnson Vice President
Peter Gough 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. For more information about NSF’s pharma biotech services, visit www.nsfpharmabiotech.org, email pharmamail@nsf.org or call +44 1751 432 999.
Rachel Carmichael Executive Director
Lynne Byers Executive Director
Catherine Kay Director
David Waddington Director
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Name · OPIS Group 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
· · · · · · · ·
Theatinerstr. 11 80333 Munich Germany Raphaela Schnurbus +49-89-710422045 +49-89-943992318 raphaela.schnurbus@opiseurope.com www.opis-europe.com www.clinical.net
· I · 250 · 1998 · Premium support for clinical drug and device development
External · l Pharma Collaborations l Biotech l Medical device companies l Nutraceutics l Academic Institutions l Non-profit organisations
The company OPIS is a European clinical CRO providing premium support for the management of global clinical trials from phases I to IV as well as pre- and post-marketing medical device investigations. Founded in 1998, the company has 20 years of extensive experience in a wide range of therapeutic areas. Its recent oncology/immuno-oncology portfolio amounts to over 400 trials. OPIS’s strength lies in its people and its specialised teams, who assist clients from A-Z with medical writing, scientific and statistical consultancy for trial design and skilled teams of operational staff across Europe, ensuring high-quality project execution. The OPIS e-clinical suite is developed to streamline the digitalisation of clinical data. Fully FDA 21 CRF Part 11 compliant and developed in close collaboration with the OPIS biometry and clinical operations units, it offers: ·· CLINICAL.NET, a modular and extremely userfriendly platform to handle all clinical trial data ·· A consolidated platform to handle named-patient programmes digitally ·· An investigator toolkit to facilitate and coordinate patient and clinician participation in clinical trials. With flexible business models, OPIS clients come first and offers are truly shaped around the needs of individual sponsors. The OPIS teams are passionate about what they do and OPIS wants its name to stand for excellence.
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opis
Study types ·· ·· ·· ·· ·· ··
Proof of concept Phase I–IV studies Observational studies Investigator-initiated trials Medical device clinical investigations OTC, consumer healthcare
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
In a world of digitalised trials, people and experience still make the difference.
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Name · Orion Corporation 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
· · · · · · · · · · ·
Orionintie 1 02100 Espoo Finland Jari Kaunisto +358-50-966-3543 jari.kaunisto@orion.fi www.orion-cmo.fi
I 3,500 1918 Orion’s Contract Manufacturing business unit offers services for small molecule: l Drug products l APIs & custom synthesis l Packaging l Serialisation
Orion is a globally operating Finnish developer of pharmaceuticals and diagnostic tests – a builder of well-being. Orion develops, manufactures, and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients, and diagnostic tests. It is continuously developing new drugs and treatment methods. The core therapy areas of Orion’s pharmaceutical R&D are central nervous system (CNS) disorders, oncology, and respiratory illnesses for which Orion developes inhaled Easyhaler ® pulmonary drugs.
Contract manufacturing services Experienced manufacturer of several dosage forms & APIs Orion has six modern pharmaceutical plants all located in Finland. We manufacture hormonal gels and solutions, small volume parenterals, tablets, capsules (conventional and cytostatic), creams, ointments, and liquids, including nasals and APIs for global markets.
Biological Patents · €1,018m
We can offer a wide range of services As a full-scale pharma company, Orion has broad experience in providing its contract manufacturing customers with extensive services, from R&D support to regulatory know-how and comprehensive supply chain operations.
Technology transfer and project management Orion has vast experience in technology transfer projects with various customers. We utilise modern project management tools that have proven themselves in practice.
Excellent customer service Our contract manufacturing customers range from small/ virtual to big pharma companies. Our services are tailored to meet each customer’s specific expectations, and excellent service level and our flexible, service-oriented way of working makes us your partner of choice.
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orion
Special expertise in hormonal semi-solids and solutions We have decades of experience in working with hormonal gels and solutions and we constantly developing our capabilities in this area. In July 2014 we started operations in our new production department and we have also installed two new manufacturing units in the last two years. We are happy to offer our services in this strong area of ours.
Serialisation & packaging Orion has invested in new serialisation capacity at several packaging sites. With strong internal know-how, the company is ready to adapt to the upcoming serialisation requirements of global pharma markets. Over the last years, Orion has been preparing for upcoming regulations well in advance and has added serialisation as an important new capability to its already strong repertoire of manufacturing and packaging methods. The company already delivers serialised products from packaging lines capable of serialisation to markets like Korea and China.
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Name · Pierre Guérin SAS Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Address Internet Website Number of Employees Founded (year)
· · · · · · · · · ·
179 Grand’Rue 79210 Mauzé-sur-le-Mignon France Mr Doru Felezeu +33-549047800 +33-549733189 contact@pierreguerin.com www.pierreguerin.com 400 1949
Areas of Activity · l Fermenters l Bioreactors l Process stainless steel vessels l CIP units l Automation l Agitators
Pierre Guérin SAS designs and manufactures equipment for life sciences and food & beverage industries from its two production sites located in the West of France. Our industrial resources (390,000 h/year) and vertical integration of the manufacturing (vessels and agitators, pre-mounted and pre-wired skid assemblies, automation, static and dynamic tests in our plant) will guarantee our customers: ·· the quality of their equipment ·· smooth project management ·· on-time delivery, brief installation and commissioning period.
Our turn key solutions include: ·· design studies for process and equipment in accordance with the most stringent standards (GAMP, ASME BPE, CFR, EHEDG, FDA, ATEX) ·· a well-adapted quality organisation and project management with PQP, test protocols (FAT/SAT), and comprehensive documentation supporting the equipment qualification ·· a well-organised and reactive customer service Our capabilities and experience in engineering and manufacturing, coupled with management capability for international large-scale projects, enable Pierre Guérin to bring global solutions to the biopharmaceutical, food & beverage and cosmetic industries, with recognition as a reference supplier in the sector. Our intra-group competencies and expertise reinforce our know-how and encourage our spirit of creativity. As part of our total quality policy based on principles of continuous improvement, we always share our experiences with our clients. Our reputation is based on the capability of our teams to manage technical and complex projects and ultimately provide equipment of the highest quality, while fully respecting the clients’ unique specifications and meeting or even surpassing expectations.
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pierre guerin
Our products and services ·· Process vessels integrating sophisticated and innovative features in agitation, mixing, heat transfer, and cleaning-in-place ·· Bioreactors and fermenters for the production of pharmaceutical biological forms (vaccines, hormones, immunobiologics), ingredients, enzymes for food & beverage applications, cosmetic raw materials, and biofuels microbial actives ·· Turnkey installations for sterile pharmaceutical forms in the GMP environment (parenteral, nasal, auricular, ophthalmic, and blood-derivative products) ·· Cream mixers and turn key installations for personal care applications (creams, ointments, lotions, shampoos, hydrotherapy) ·· Turnkey installations for baby food and clinical nutrition ·· Cleaning-in-place units ·· Control systems ·· System maintenance and spare parts, equipment retrofits and automation upgrade, IQ/OQ, audit, consultancy, and trouble-shooting
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Name · Polpharma Biologics Address/P.O. Box · Gdansk Science and Technology Park Trzy Lipy 3 bld A Postal Code/City · 80-172 Gdansk Country · Poland Contact Person · Karolina Flejszman (PR and Marketing Assistant) Telephone · +48-785884487 Email Address · onestopshop@polpharma.com Internet Website · www.polpharmabiologics.com Social Media · I Number of Employees · 180 Founded (year) · 2013 Type of Laboratory · State of the art biopharmaceutical development centre for process development and optimization, clinical trials material production, and the commercial supply of drug substances and drug products Areas of Activity · Contract development and manufacturing of biopharmaceuticals in cell culture and bacterial expression systems, including Fill&Finish External · Bioceros (cell line development), Collaborations BSP (antibody drug conjugates), BioEq (Biosimilars), universities, and research institutes
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 customized solutions for all stages of development and production to serve today’s and tomorrow’s global market needs. Our professional 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 and Finish manufacturing in Duchnice near Warsaw, which will become operational in 2020. Total capacity of the plant will reach up to 12 x 2000 L cell culture production and aseptic F&F of 30 mio vials and carpules.
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
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POLPHARMA
ONE-STOP SHOP
COMMERCIAL GMP MANUFACTURING
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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 strategic partnerships and longterm projects with shared responsibility for development. We can support all stages of your biopharmaceutical development process, and secure an on-time commercial launch and subsequent supply at economically attractive conditions by leveraging our cost-effective footprint – or offer 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 commercialization and future sales in the region. The recent investments of Polpharma Biologics speak for themselves – we make things happen. The biopharmaceutical one-stop shop is waiting for you.
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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 · 115 · 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.
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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
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We W
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. Site-specific antibody drug conjugates A novel, site-specific, enzymatic ADC technology is available for licensing or in-house development, fully compatible with ProBioGen’s development platform. 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. 8 th european biotechnology guide 2018
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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.com www.progen.com
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 · €3.8m 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
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Progen
passion for research 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.
Antibodies Antibodies AAV-Tools AAV-Tools Phage display technology Phage display technology ELISA ELISA Density gradient media Density gradient media
Collaborations to meet existing and future demands 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.
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Name · ProQinase GmbH 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
· · · · · · · · · · · ·
Breisacher Str. 117 79106 Freiburg Germany Dr Christoph Schächtele +49-761-769996-0 +49-761-769996-1781 info@proqinase.com www.proqinase.com
I 37 2001 Drug discovery in oncology
External · Multiple collaborations with academic Collaborations institutions and biotech companies Request for · Together with experienced chemistry Further Collaborations providers, ProQinase offers integrated drug discovery projects 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.
History ProQinase was founded in 2001 as a 100% subsidiary of the Tumor Biology Center Freiburg. In 2015 the company was acquired by the Chinese investor China Equity Group. The company’s unique cancer drug discovery platform has been used successfully for internal drug development projects in the past. For some years now, ProQinase’s focus has been 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 · Recombinant lipid kinases · Recombinant substrates for protein kinase activity assays · Custom-tailored recombinant protein production Biochemical assay services Biochemical kinase activity 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 broad panel kinase profiling with 410 protein and lipid kinases · Binding assays for protein-protein interaction Cell-based assay services · Target-specific cellular phosphorylation assays · Cell proliferation assays · Soft agar assays · Cell migration assays · 3D tumour spheroid assays · Cellular angiogenesis assay
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Proqinase
Recombinant Proteins
Biochemical Assay Services
In vivo testing services ·· Xenograft mouse tumour mModels (subcutaneous, orthotopic, metastasis) ·· Immuno-oncology platform with syngeneic mouse tumour models ·· Unique, proprietary syngeneic mouse tumour models ·· In vivo angiogenesis model
Worldwide customers ProQinase offers its tools and services worldwide to pharmaceutical and biotech companies of any size, as well as to academic institutions. In 2017, 6 of the 10 leading pharma companies used ProQinase’s services.
Business models
Cellular Assay Services
ProQinase offers any product or single service module on a fee-for-service basis. In addition, ProQinase strives for long-term relationships with clients that are interested in integrated drug discovery projects starting from hit identification up to proof of concept in animal models.
Personnel
In Vivo Testing Services
Our team of internationally trained scientists has more than 20 years of experience in cancer drug development as proven by participation in numerous publicly funded multi-national projects and more than 100 peer-reviewed scientific publications. Together with our now 17 years of experience as a service provider for clients from all fields of oncology, this makes ProQinase a qualified and reliable partner for cancer drug discovery.
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Name · Protavio 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 CB1 2JD Cambridge United Kingdom Leonidas Alexopoulos +44-1223803801 Info@protavio.com www.protavio.com
FI 9 2012 Biotechnology (GMP compliant) l Early drug discovery l Biomarker discovery l Multiplex assay development l Multi-omics data analysis
Annual turnover · €650,000 Relevant R&D Budget · €250,000 Biological Patents · l Proprietary multiplex technology l B iomarkers for cardiovascular disease l Drug repositioning for non-alcoholic fatty liver disease External · l Roche Collaborations l Harvard Medical School l Philip Morris International Request for · l In-vitro diagnostic assay Further Collaborations development l Discovery of biomarkers & companion diagnostics l Drug repositioning l Network-based early drug discovery
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Protavio, the art in multiplexed assays Protavio Ltd is a leading provider of cutting-edge invitro and in-silico services and products for biomarker discovery and compound evaluation. We offer scalable solutions for companies of all sizes, ranging from top pharma to CROs, SMEs, academic centres, and regulatory agencies. We build on our expertise and proprietary technology in multiplex assay development and feature a versatile team of bioengineers, molecular biologists, biochemists, and bioinformaticians who can assist with any project’s needs. Our state-of-the-art equipment and GMP- and ISO-compliant facilities and procedures ensure the quality of our work and provide peace-of-mind to our customers.
Biomarker discovery Protavio offers a comprehensive biomarker discovery platform that combines unprecedented proteome-wide screening with in-silico interrogation of data for biomarker performance and evaluation. Proprietary multiplexing technology and a vast array of antibodies are used to screen over 1,000 proteins, increasing the chances of identifying biomarkers of high performance. The best biomarkers are evaluated for their prognostic, diagnostic, or predictive power, and selection criteria for patient stratification decisions are set. Standardised dedicated panels of species or disease-specific biomarkers are also available and cover biomarkers of interest in: ·· cancer (cancer-plex), ·· cardiovascular diseases (cardio-plex), ·· metabolism (metabolic-plex), ·· kidney disorders (nephro-plex), ·· immune responses (immune-plex), ·· secreted proteins (secretome-plex) & ·· markers for central signaling pathways in cells (path-plex).
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PROTAVIO
Assay development & GMP-compliant production Here at Protavio we know how to build assays for any type of application including biomarker discovery, serological testing for vaccine testing, pathway analysis, quality control, PK/PD, screening studies, etc. Using diverse coupling techniques, we can immobilise many different types of molecules (antibodies, affimers, proteins, oligonucleotides, etc.) and employ detection schemes (sandwich assay, single antibody, direct labeling, etc.) that fit your project specification. If large-scale production is needed, three different types of robots can be programmed to meet production requirements. Following EMA, FDA, and CLSI guidelines we assess assay performance for limits of detection, precision, accuracy, linearity, and recovery. Our quality control extends the industry standards and includes proprietary QC methods that ensure the best assay precision on the market. Our production process guarantees that your assays will be produced with the best industry standards that can meet IVD requirements.
Compound evaluation Our service offers the ultimate in-vitro solution for drug discovery in order to evaluate candidate and lead compounds. We generate a wealth of new data through omics analysis (gene expression, multiplex assays, high content screening, etc.) of over 50 in-vitro models composed of primary cell cultures from diverse organs in healthy and diseased states, which we then integrate with existing knowledge databases. Advanced network analysis is used to extract information on mode-of-action, predict efficacy and toxicity ,and eventually identify lead compounds and/or repurpose existing drugs.
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Name · Recipharm Address/P.O. Box Postal Code/City Country Telephone Email Website Social Media Number of Employees Founded (year)
· · · · · · · · ·
Box 603 13102 Stockholm Sweden +46 8 602 52 00 info@recipharm.com www.recipharm.com
I 5,000 + 1995
Areas of Activity · l Contract manufacturing for clinical trial material or commercial supply l Contract development l Synthesis and analytical chemistry l Analytical development l Formulation development
Recipharm is a leading contract development and manufacturing organisation (CDMO) headquartered in Stockholm, Sweden. We operate development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK, and the US, and are continuing to grow and expand our offering, for our customers. Employing around 5,000 people, we are focused on supporting pharmaceutical companies with our full service, taking products from early development through to commercial production. For over 20 years we have been there for our clients throughout the entire product lifecycle, providing pharmaceutical expertise and managing complexity, time and time again. Despite our growing global footprint, we conduct our business as we always have and continue to deliver value for money with each customer’s needs firmly at the heart of all that we do.
Annual Turnover · €550m
We provide support to pharmaceutical companies of all sizes with their outsourcing requirements, with our company operating in two core areas.
Contract manufacturing services Recipharm’s largest business stream is manufacturing services. Our pharmaceutical manufacturing expertise means we can deliver a large number of pharmaceuticals in a variety of dosage forms requiring the use of a broad range of technologies, including: ·· Solids ·· Semi-solids ·· Liquids ·· Injectables ·· Ophthalmics ·· APIs
Member of
European Biotechnology
As part of our manufacturing services, we also provide our customers with a comprehensive packaging service in a large number of variants. We also help our customers by simplifying their processes and managing complexities. We do this by offering additional services such as quality assurance, regulatory services, and logistics
NET WORK
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solutions, including Vendor Managed Inventory (VMI). For many of our clients that utilise our manufacturing capabilities, it is important that we have a solid foundation in drug development. We are proud to possess a broad pharmaceutical expertise that is essential in developing and supplying drug products.
Contract development services Our development & technology segment offers clients a comprehensive range of services, with the aim of supporting the customer from the initial product concept to the approved pharmaceutical drug, in some cases, through various forms of risk sharing. We are able to offer both experience and expertise in various services including: ·· GLP bioanalytical services ·· Antibody-drug conjugates and bioconjugates services ·· Custom synthesis ·· Medicinal chemistry ·· Optimised excipient selection ·· Recipharm Pathway to Clinic® ·· Extractables & leachables testing ·· Impurity identification ·· Stability studies ·· Inhalation and nasal formulation development ·· Tablet formulation ·· Topical & transdermal formulation development ·· Preformulation ·· Clinical supply ·· Project management ·· Regulatory support Within this business area, there is also a portfolio of product rights, which forms the basis of distribution through external partners. Through an integrated knowledge exchange between Recipharm’s manufacturing and development units, the skills and experience we have are used to improve the development organisation. Furthermore, this operating model helps to achieve a degree of efficiency and ensures quality when a pharmaceutical drug transitions from the development phase through to the manufacturing phase. That’s the Recipharm way. 8 th european biotechnology guide 2018
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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 · +44-1625469929 Email Address · m.craighead@redxpharma.com Internet Website · www.redxpharma.com Number of Employees · 40 Founded (year) · 2010 Type of Laboratory · l Medicinal Chemistry l Pharmacology l DMPK Areas of Activity · l Oncology l Fibrosis External · l AstraZeneca Collaborations l Innovative Medicines Initiative Request for · Small molecule agents with activity as Further Collaborations anti-fibrotic agents or in the area of immuno-oncology/targeted therapies in oncology
Redx Pharma discovers and develops proprietary, smallmolecule drugs to address areas of high unmet medical need in oncology and fibrosis. In oncology, we pursue targeted therapies where a biomarker can potentially be used for selecting those patients who are most likely to benefit from therapy, and/or drugs that are designed to disrupt cancer resistance pathways. In fibrosis, we are focused on developing treatments that will stop and reverse the formation of fibrotic tissue. In both therapeutic areas we aim to develop drugs whose profile suggests they will be best in class, if not first in class. Redx is actively looking for new partners/ projects in our areas of interest, which will allow us to continue to bring assets from early hit stage through to proof of concept in humans. With our proven track record of success and strength in areas such as medicinal chemistry, pharmacology, and DMPK, we feel we could be excellent partners and add value to any programme. In 2017 our R&D model was validated when we partnered our reversible BTK inhibitor (RXC005), which was in preclinical development. RXC005 was being developed for the treatment of various B-cell leukaemias and lymphomas, as well as having potential efficacy in B-cell-driven auto-immune conditions. Loxo Oncology Inc purchased the programme for $40m and will now be taking the programme into clinical development. Within the area of oncology our most advanced programme focuses upon inhibition of porcupine (a key enzyme in the WNT signalling pathway). Our scientists have identified specific genetic alterations in the RNF43 (a key regulator of the WNT pathway) in types of gastric, pancreatic, and biliary cancer, which can be used to predict which patients are most likely to benefit from treatment with RXC004.
Member of
European Biotechnology
In addition, many tumours are “cold” in that the tumourkilling immune cells are not present at the tumour site. Evidence is emerging that the WNT signalling pathway is relevant in this process such that inhibition of the pathway may make the tumours “hot” by facilitating tumour-killing immune cells into the tumour.
NET WORK
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Our novel porcupine inhibitor (RXC004) has the potential to be used as a biomarker-guided, targeted therapy in hard-to-treat cancers, and as a combination product in immune-oncology treatment paradigms with immune checkpoint inhibitors. Immune checkpoint inhibitors have been approved in a broad array of tumour types, for example non-small cell lung cancer (NSCLC) and melanoma. This programme is rapidly progressing towards the clinic with the first human dosing scheduled for first quarter 2018. In 2017, within the area of fibrosis, we acquired a ROCK inhibitor programme from the Belgian company Amakem. The aim of the programme is to produce a drug that acts locally in the gut to treat fibrosis arising from inflammatory bowel disease (IBD). The current management of symptoms is primarily surgical as there are no anti-fibrotic drugs approved. ROCK1 and ROCK2 are intracellular kinases with multiple functions, and have been shown to be implicated at various points in pathways leading to fibrosis. However, systemic ROCK1/2 inhibitors (known as systemic pan-Rock inhibitors) are known to induce hypotension, and are therefore unlikely to be tolerated. Our ROCK inhibitor is designed to work only at the site of action in the gastrointestinal tract and degrades quickly, once absorbed, through enzyme-mediated metabolism in the blood – making it a “soft” inhibitor. Prophylactic and therapeutic effects on fibrosis by a “soft” pan-ROCK inhibitor have been demonstrated in multiple animal models. Our “soft” ROCK inhibitor is designed to prevent surgical intervention, thereby improving patients’ lives, and we plan to nominate a pre-clinical development candidate in H1 2018.
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Name · Rentschler Biopharma SE 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 Alexander Starnecker +49-7392-701-0 +49-7392-701-300 info@rentschler-biopharma.com www.rentschler-biopharma.com
FIQ 800 1927 S1 l Contract bioprocess development and manufacturing partner for biopharmaceuticals l Focused on mammalian cell culture l Aseptic filling of biopharmaceuticals l Project management l Global regulatory support
External · l Strategic alliance with Leucokare AG, Collaborations located in Munich, Germany for formulation development l Strategic partnership with Rentschler Fill Solutions GmbH, located in Rankweil, Austria for aseptic filling Request for · Rentschler Biopharma seeks pharma Further Collaborations and biotech companies needing bioprocess development and cGMP manufacturing solutions and interested in long-term collaborations
Passion for performance Rentschler Biopharma is a biotechnology pioneer, specialising in mammalian cell culture with expertise in protein therapeutics. 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. Founded in 1927, Rentschler Biopharma is a familyowned company located in Laupheim, Germany employing more than 800 people. Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler Biopharma’s high-quality standards. Rentschler Biopharma provides an essential contribution to the global availability of biopharmaceuticals and thereby helps millions of people with serious and rare diseases.
Full-service concept The full-service offering of Rentschler Biopharma covers all activities from bioprocess development through to manufacturing, analytical characterisation to fill & finish. Our experience covers the manufacturing of protein therapeutics such as monoclonal antibodies, fusion proteins, cytokines, and enzymes, in compliance with international cGMP standards (EMA/FDA). The stateof-the-art cGMP facilities and cell culture processes allow us to manufacture material for clinical phases and commercial supplies. Constant monitoring of regulatory environments and extensive experience in the creation of approval documents at an international level ensures that each project is documented in accordance with regulatory requirements. The strategic alliance with Leukocare AG aims to incorporate formulation development at every step throughout biopharmaceutical development and manufacturing.
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Rentschler Biopharma
Working closely with the client, this will ensure that the end products will – from the very beginning – have an advanced formulation and administration mode. This innovative approach will provide clients significant competitive advantages, enabling them to exploit the full potential of their products and markets. The strategic partnership with Rentschler Fill Solutions provides one-stop solutions with new state-of-the-art fill and finish facilities and unites two centres of excellence for fast and efficient bioprocess development, manufacturing, and filling of biopharmaceuticals with the Rentschler commitment to quality. Bioprocess development ·· Development of production cell lines ·· Development and optimisation of cell culture and purification processes ·· Process characterisation and validation ·· Advanced formulation development ·· Development, qualification, and validation of analytical methods cGMP manufacturing and aseptic filling ·· Clinical and commercial drug substance manufacturing ·· Stainless steel bioreactors for up to 3,000 L ·· Single-use bioreactors for up to 2,000 L ·· State-of-the-art purification processes ·· Production, testing, and storage of master and working cell banks ·· Aseptic liquid filling in vials and lyophilisates Associated consulting activities ·· 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 the complete documentation for approval (IND/IMPD CMC parts)
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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 171 1987 Contract development and manufacturing of biopharmaceuticals derived from microbial systems
Biological Patents · Several patents on the manufacture of recombinant proteins 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.
German reliability and thoroughness Richter-Helm is a Hamburg, Germany-based contract development and manufacturing company specialised in products derived from bacteria and yeasts, with a proven 30-year track record. Count on us to flexibly provide a comprehensive range of services and customised solutions. Clients worldwide have already benefited from our commitment to good manufacturing practice and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Our seasoned, 170-strong team supports you with process development, the supply of products for clinical trials, commercial production, in-house QC testing, and QP release. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 litres. Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies including EMA, FDA, ANVISA, and MFDS, as well as by numerous customer audits. 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 the co-development and marketing of microbial-derived biopharmaceutical products.
For more detailed information please contact us.
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Richter-Helm
Products and services The teams at Richter-Helm have excellent expertise in the development and GMP-compliant production of biologics and biosimilars. Richter-Helm thus offers a full range of biopharmaceutical services: ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ··
Strain development (e.g. E.coli) Establishment of cell banks (MCB/WCB) Process development (USP/DSP) Process optimization Development of analytical methods (incl. biological assays) Validation of analytical methods In-house QC testing and release GMP manufacturing for phases I to III Commercial GMP manufacturing Process characterization Process validation Stability studies according to ICH Regulatory support
Thanks to the broad knowledge of Richter-Helm’s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailormade solutions for its customers. Each project is treated individually and with the highest flexibility from RHB’s site.
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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)
· · · · · · · · · · ·
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
Areas of Activity · 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
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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.
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Name · RTC S.p.A. Address/P.O. Box Postal Code/City Country Contact Person Telephone Email Address Internet Website Number of Employees Founded (year)
· · · · · · · · ·
Via Tito Speri 12/14 00071 Pomezia (Rome) Italy Danilo Bucci +39-06-91095-696 dbucci@rtc.it www.rtc.it 150 1972
Areas of Activity · Toxicology and safety assessment of: l Pharmaceuticals (Small molecules, biologicals) l Medical devices l Veterinary drugs l Biosimilars l Food products (Novel food, food additives and food ingredients) l Chemicals l Agrochemicals l Bioscides
Research Toxicology Centre RTC is a Contract Research Organisation specialised in non-clinical safety studies for product registration according to current international regulatory requirements. RTC is a leading CRO in Europe with more than 40 years of worldwide experience, providing high quality in non-clinical research management to national and international pharmaceutical companies and other health-related organisations. RTC offers a full range of experimental and consultancy services, performed by skilled professionals, for the development and safety assessment of: ·· Pharmaceuticals · Small molecules · Biologicals ·· Medical devices ·· Biosimilars ·· Food products ·· Chemicals ·· Agrochemicals ·· Biocides For each class of products, studies are performed according to international guidelines and regulations. RTC high-standard quality is guaranteed through the approval of European, American, and Japanese authorities. Scientific and technological expertise, combined with skills in project management and communication, together with the ability to provide clients with competitive, fast, and reliable service, qualify RTC as the partner of choice for product development.
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RTC
Why RTC? Competence The quality of the services offered by RTC is assured by personnel highly specialised in their respective disciplines and with excellent communication skills. Our facilities and equipment are regularly updated in response to scientific, technical, and regulatory demands. We constantly improve our methods and techniques to meet current standards, thus providing the best up-to-date solutions for our clients. Our organisation is committed to ensuring efficient communication and timely, reliable, and high-quality services.
Experience People are our most important resource and we have succeeded in recruiting professionals of the highest competence. Our senior staff represents many years of industrial and/or contract research experience and therefore fully understands the specific requirements of our clients. The international scientific background and the diverse cultural and linguistic origins of the key personnel contribute to adding value to our services.
Reliability Serving our clients is our utmost priority. That is why RTC is deeply committed to meeting your needs and attending to every detail of your project. We will guide you during the selection of the experimental design and provide tailored solutions. RTC will ensure close monitoring of each study phase to respect quality and timing. Furthermore, our staff will constantly keep you informed of progress, every step of the way, since communication and collaboration are essential to achieving success.
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Name · Sartorius Stedim Biotech Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity
· · · · · · · · · · · ·
August-Spindler-Str. 11 37079 Goettingen Germany Dominic Grone +49-551-308-0 +49-551-308-3289 info@sartorius-stedim.com www.sartorius-stedim.com
I 5,092 (for 2017) 2007 Cutting-edge products, technologies, and services for biopharmaceutical applications
Annual Turnover · €1.081bn (fiscal year 2017)
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and valueadded services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America, and Asia and a global network of sales companies, Sartorius Stedim Biotech has a global reach.
Products and services Fermentation The widest range of bioreactors and fermentors from benchtop to process scale and from disposable to reusable technologies. Filtration A complete, scalable array of filter capsules and cartridges for all bioprocessing steps – backed by decades of experience in filter technologies. Purification A leading position in crossflow filtration, membrane chromatography, and virus removal technologies for state-of-the-art initial recovery and contaminant clearance in biomanufacturing.
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sartorius stedim biotech
Fluid management Pioneer and leader in single-use systems, freeze-thaw processing and aseptic transfer systems, with the most extensive capabilities for creating fully integrated, single-use biomanufacturing solutions. Media Sales and marketing of cell culture media and buffer solutions for biopharmaceutical manufacture. Services Expert services for process development, process optimisation, validation, and regulatory support – rapidly deployable and globally available.
Management – executive committee of the board Dr Joachim Kreuzburg Chairman of the Board and Chief Executive Officer Volker Niebel Executive Vice President of Operations and IT Dr Oscar-Werner Reif Executive Vice President of Research and Development Reinhard Vogt Executive Vice President of Marketing, Sales and Services
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Name · Socorex Isba SA Address/P.O. Box Postal Code/City Country Contact Person
· · · ·
Chemin de Champ-Colomb 7a 1024 Ecublens Switzerland Yves Lachavanne (Marketing & Sales Support Manager) Telephone · +41-21-651-6000 Email Address · socorex@socorex.com Internet Website · www.socorex.com Social Media · FL I Number of Employees · 55 Founded (year) · 1963 Areas of Activity · Liquid handling instruments
Your partner in precision volumetry Socorex Isba SA is a Swiss manufacturer of highly reliable laboratory instruments used for measuring, dosing, transferring, dispensing, and injecting liquids in a large number of applications. Manual and electronic micropipettes, single and multichannel pipettors, repeater pipettes, dispensers, pipette controllers, and re-usable syringes, together with pipette tips, consumables, and accessories, constitute the heart of the programme. The company is committed to manufacturing the most reliable products and to offering the best services. “A to Z” Quality Management includes quality checks and individual instrument performance control in the metrology laboratory, attested by an individual ISO 8655 certificate. Warranty coverage is three years on all manual pipettors and two years on electronic pipettes, dispensers, and repeaters. The efficient service centre offers a global maintenance programme in its Ecublens-accredited laboratories. The selection ranges from basic checks to ISO 17025 accredited calibrations of all micropipettes and dispensers – whatever their brand. Selected amongs the best laboratory equipment suppliers, an international network of distributors carries a stock of products and provides technical support, repairs, and calibration services.
Key products for biotech labs Acura® manual micropipettes – exceptional ergonomics The adequate shape of the finger rest maintains the micropipette in position without hand stress. The adjustment button allows easy volume setting, even when using a glove. Located at the front of the instrument, the display window is visible at all times during pipetting. The soft springs and tightness ring with PTFE sleeve reduce friction and make plunger activation smoother than ever. Ergonomically positioned, the large-surface, soft-padded ejector button allows low-pressure activa-
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tion. In addition, JustipTM shaft height adjustment system allows a wide selection of tips to tightly fit the nozzle. Qualitix® – pipette tip programme Made from virgin polypropylene and free from DNAse, RNAse, pyrogens/endotoxins, and ATP, the tips provide for a very high purity degree. In addition, sterile tips are certified free of human DNA. Intended for accurate liquid delivery, the new Qualitix® ideally combines with Socorex® and all major micropipette brands. The tipfill rack filling system enables easy rack loading. Each insert is instantly transferred into an empty rack without risk of contamination. Its simplicity of use makes tipfill a convincing choice. The handling of viscous liquids is facilitated when using low-protein binding tips. Certified protease free, they are well adapted in the proteomic field. Sterile tip users now have the choice between models with and without a protection filter. Bottle-top dispensers – excellent chemical resistance Intended for safe and reproducible liquid distribution, the CalibrexTM dispenser line includes 7 different sizes: 0.1–1 / 0.25–2.5 / 0.5–5 / 1–10 / 2.5–25 / 5–50 / 10–100 mL. ·· CalibrexTM organo 525 suited for organics and noncrystallising solutions. ·· CalibrexTM solutae 530 for trouble-free distribution of salt solutions, weak and strong acids, and bases. Volume setting with a spring-loaded sliding cursor, softly moving up and down along the dual scale. Thanks to the optional flow control stopcock for priming dispenser, reagent is recycled without loss or contamination. Valves, plunger, barrel, and delivery jet are removable in seconds for cleaning. The printed QR code allows instant access to the chemical resistance chart. Fully autoclavable at 121°C. Access to calibration mechanism is protected by a safety seal sticker. The integrated key is located under the plunger cap.
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Name · Swiss Biotech Association Address/P.O. Box Postal Code/City Country Telephone Email Website Number of Employees Founded (year) Areas of Activity
· · · · · · · · ·
Stauffacherstrasse 16 8004 Zurich Switzerland +41-44-455-56-78 info@swissbiotech.org www.swissbiotech.org 1.5 (FTE) 1998 National cluster development powered by Swiss Biotech Association
External · National and international Collaborations stakeholders of the Swiss Biotech Ecosystem
Connecting biotech Swiss biotech has established itself as one of the most reputable and innovative industry sectors in Switzerland. Represented by the Swiss Biotech Association, it connects people and organisations efficiently and aims at identifying, communicating, and utilising the advantages of modern biotechnology for the benefit of society.
A unified voice 2018 marks the 20th anniversary of the Swiss Biotech Association. It speaks with a unified voice for the interests of the biotech community in Switzerland and generates value by: Developing optimal framework conditions
Request for · National Thematic Network Further Collaborations Swiss BiotechTM
Networking with stakeholders at the national and international level Supporting the exchange between industry, academia, and other cluster regions Collaborating with strategic partners in life sciences clusters and funding agencies Increasing the visibility of the Swiss biotech industry and its accomplishments Providing privileged information, offering discounts for services and events, and enabling direct interaction for its members
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Swiss Biotech
United forces lead to the summit
1Nation1Cluster
Join the Swiss Biotech Association Activities of member companies comprise different sectors of biotechnology, including pharmaceuticals, industrial and environmental biotech, food and agriculture, bioequipment, bioinformatics, analytics, and diagnostics, as well as research and manufacturing services. Currently, more than 15,000 employees are directly engaged in Swiss biotech companies. Additionally, 40,000 indirect jobs at suppliers and service providers contribute to the success of the Swiss biotech sector.
Become a member of the biotech community and contact us for more information: info@swissbiotech.org
Swiss Biotech offers many paths to success. the tion Join Associa h iotec ay B s tod Swis
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Name · TROCKLE Business Consultancy Address/P.O. Box Postal Code/City Country Contact Person Telephone Email
Address/P.O. Box Postal Code/City Country Telephone
· · · · · ·
· · · ·
Swiss Office Geimoosstr. 12 8712 Stäfa/Zurich Switzerland Susanne Simon, PhD +41-43-818-0334 simon@trockleunternehmensberatung.com Headquarters Am Buschhäuschen 9 42115 Wuppertal Germany +49-202-31-10-00
Further offices · Düsseldorf, Hannover Website Number of Employees Founded (year) Type of Laboratory Areas of Activity
· · · · ·
trockle-unternehmensberatung.com 10 1991 Business Consultancy Recruiting and organisational consultancy in healthcare/life sciences (biotechnology, IVD, medical devices, diagnostics, Pharma) in DACH / Europe with a focus on German speaking markets
Successful executive recruitment requires industry insight, HR expertise, and a keen eye for market trends. Every consultant at TROCKLE Business Consultancy has the insight, expertise, and current market knowledge to deliver on our promise of successful placement of the right candidate for you.
Our organisation For over 25 years, TROCKLE Business Consultancy has supported European biotechnology, medical device, IVD, pharmaceutical, healthcare, and life sciences institutions in the challenging realm of executive recruitment. Our goal is to ensure that our clients have the optimum talent with the minimum burden on their management during the recruitment process. We also focus on giving candidates fair and transparent treatment.
Our team Our consultants have various academic backgrounds, including science, medicine, economics, and engineering, but all have spent at least 10 years in leadership positions in international healthcare companies. Coupled with our HR expertise, this helps us understand your business, position-specific challenges, and the opportunities that your new executive recruit can leverage for your continued success.
Track record Our track record speaks for itself, with candidate placements in life sciences and healthcare companies at all hierarchy levels, from specialists to CEOs, and all functions, including R&D, quality, regulatory affairs, operations, marketing and legal, but also Finance and HR.
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trockle
TROCKLE Business Consultancy has: ·· Profound knowledge of the biotechnology, medical device, IVD, pharmaceutical, healthcare, and life sciences industries ·· An excellent applicant and client network, bolstered by memberships in medical and HR communities ·· A unique set of tools for direct searching ·· Well-developed methodologies for coaching and onboarding ·· A “one face, one project” approach to ensure close and continuous communication through the recruitment process
Our core business We identify managers and experts and inspire them to engage with new tasks. Our missing is to find the individual with the skills and career aspirations to meet the specific business needs of the role. Thanks to our detailed knowledge of the industry, we understand the challenges and opportunities specific to companies, roles and sectors.
Excellent leaders and specialists make the difference.
TROCKLE supports the entire process, from search and first contact through contract negotiations to integration into new role. Our many years of experience, extensive network and excellent contacts put us in the best position to perform the complex and difficult tasks involved. We will help you find the best available staff for your enterprise Contact us when you want to fill a vacant position with an appropriate candidate. We’ll be happy to partner you through the challenges of recruitment and find the right person for you. We are equally happy to speak with people who are actively seeking challenges, changes or new roles, as well as people that are just looking to explore the market and to expand their horizons.
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Name · UBM Address/P.O. Box · De Entreé 73, Toren A Postal Code/City · 1101 BH Amsterdam Country · The Netherlands bioLIVE office Address/P.O. Box · IFEMA Madrid Av. Partenón, 5 Postal Code/City · 28042 Madrid Country · Spain Contact Person · Rutger Oudejans, Brand Director Telephone · +31-207-081-767 Email · rutger.oudejans@ubm.com Website · www.bio.live Social Media · FL I Number of Employees · UBM (ca. 4,000) Pharma Portfolio (over 100) Founded (year) · 1990 (UBM) 2017 (bioLIVE) Areas of Activity · l Biopharmaceutical events including processing and manufacturing l Pharmaceutical events l Biotech events l Conferences
bioLIVE is a new, focused event, including an exhibition and a live content stage, that establishes premiumclass, global leadership in bioprocessing and manufacturing. The event aims to bring the small and largemolecule worlds together, creating a unique platform where both industries can learn from each other.
A strong platform The event will act as a global hub for both upstream and downstream processing and manufacturing, connecting biotechs, big pharma, and service providers, including CDMOs and CROs, from early stage development to commercial manufacturing and regulatory services. It will also feature diverse audiences, from biogenerics and bioinnovators to manufacturing and laboratory specialists.
Leveraging expertise and experience bioLIVE runs alongside CPhI Worldwide and iCSE 2018 at IFEMA in Madrid. CPhI attracts over 45,000 pharma professionals from over 50+ countries and the event will significantly benefit from the synergies and the exceptional audience of CPhI, which currently caters to the small-molecule sector of the pharma industry. Leveraging the existing expertise and strong knowledge of manufacturing and processing that has been built over the last 28 years, bioLIVE will establish the most comprehensive opportunity for the biopharma community to do business, network, and learn. bioLIVE will benefit: ·· Big pharma’s bio divisions and biopharma giants that are looking for specific niche services ·· Small & midsize bio innovators wanting to feed into the pipelines of big pharma and looking for help for their drug development and commercialisation ·· Small & midize service providers ·· Producers of specialised bio (scientific lab) equipment, such as high-performance liquid chromatography ·· Big pharma and midsized Bio CDMO’s interested in showcasing their commercialised products, vaccines & biosimilars
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How to get involved? Exhibit with us: Be at the forefront of innovation and seize the opportunity to showcase your latest products & services. Meet the right buyers on site and benefit from an extensive pre-show promotion from the bioLIVE marketing campaign.
50+
45+
COUNTRIES
HOURS OF CONTENT
3000 150
ATTENDEES
EXHIBITORS
3 DAYS OF NETWORKING OPPORTUNITIES
Visit us because you are a: ·· Technical buyer (someone with a technical background in procurement, sourcing, quality, and R&D: principal research scientist, single-cell applications engineer, bio analytical business manager) ·· Wholesaler and distributor or a trading company ·· Representative of biotech, large and midsize pharmaceutical company or service provider, specialising in: manufacturing & processing, R&D, and business development ·· Senior to mid-level executive of a biotech or pharmaceutical company ·· Researcher from a university or research institute ·· Professional service or consulting firm ·· Diagnostics & devices company ·· Biomedical engineering & equipment technician ·· Biomedical & clinical engineer, i.e. representative of a biotech, large and midsize pharmaceutical company or service provider, specialising in licensing or procurement ·· Investor Attend bioLIVE and you will benefit from high level content, unique matchmaking, and the right mix of exhibitors in one place. We look forward to meeting you at bioLIVE on 9–11 October at IFEMA in Madrid, Spain. For more information go to www.bio.live
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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
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
NET WORK
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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.
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Name · VAXIMM AG Address/P.O. Box · Technologiepark Basel Hochbergerstrasse 60c Postal Code/City · 4057 Basel Country · Switzerland Contact Person · 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 · Oncology drug development Oral T-cell immunotherapies External · Collaboration with Merck KGaA, Collaborations Darmstadt, Germany, and Pfizer Inc. to evaluate VXM01 with avelumab Works with leading academic 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.
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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 Company’s lead product candidate, VXM01, is an investigational oral T-cell immunotherapy targeting VEGFR2 that is designed to activate T-cells to attack the tumour vasculature, and, in several tumour types, attack cancer cells directly. A Phase I/II trial in advanced pancreatic cancer showed that VXM01 was well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Two additional clinical Phase IIa trials, one in metastatic colorectal cancer and one in recurrent glioblastoma, are currently ongoing. VXM01 has received orphan designation from the European Commission and from the US Food and Drug Administration (FDA) for the treatment of glioma, a difficult-totreat form of brain cancer. Additionally, VAXIMM has a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. to evaluate avelumab, a human anti-PD-L1 antibody, in combination with VXM01. Under the terms of the agreement, VAXIMM will be responsible for conducting two open-label Phase I/II trials – one in glioblastoma and one in metastatic colorectal cancer. 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. In addition, VAXIMM is also using its platform technology to develop a personal neoantigen approach. VXM NEO has already demonstrated immune proof of concept.
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Name · VIVEbiotech 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
· · · · · · · · · · ·
Paseo Mikeletegui 81, San Sebastian 20009 Gipuzkoa Spain Natalia Elizalde +34-683-619-708 nelizalde@vivebiotech.com www.vivebiotech.com/
I 20 2015 CDMO
Areas of Activity · l Lentivirus l Lentiviral vectors l CDMO l Lentisoma l CMO l GMP Biological Patents · LENTISOMA, non-integrative replicative patented viral vector (WO 2015/078999 A1) External · l Ciemat Collaborations l Sant Pau l CNIO l CNIC
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VIVEbiotech is a biotechnology company specialised in lentiviral vectors composed of two business units: 1. Contract development and manufacturing organisation (CDMO) 2. Own technology development
GMP lentiviral vectors CDMO VIVEbiotech is a CDMO specialised in lentiviral vectors offering custom solutions based on a review of customer requirements, in conjunction with lentivirus vector design and cloning. VIVEbiotech is specialised in the manufacture of research, preclinical toxicology and GMP-grade lentiviral vectors. In addition, VIVEbiotech offers a wide range of manufacturing-related services such as: ·· Analytical methods: development, qualification, and/ or validation ·· In-process control (IPCs) ·· Release methods ·· Stability analysis ·· Cell banking: manufacture and release ·· Fill&Finish ·· Final product release (own qualified person) ·· Stability studies ·· Back-up storage ·· Transport validation ·· Regulatory support including CMC sections of IMPD and IND ·· Comprehensive management of outsourced partners
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Own technology development VIVEbiotech’s technology development strategy is focused on providing response to the main hurdles that currently exist within the gene therapy field: ·· The need for cost-effective processes ·· The enhancement of the safety profile of viral vectors For this reason, VIVEbiotech is working in the following areas: ·· The development of improved producer cell lines and manufacturing processes ·· New pseudotyping strategies ·· Lentisoma: a worldwide patented technology (Wo 2015/078999 A1) consisting of an episomal non-integrative stable lentiviral vector, that provides a lasting, stable, consistent expression of the transgene in dividing and non-dividing cells. VIVEbiotech is currently working for US and European customers with a continued and sustained increase in personnel (more than 40% PhDs, 95% graduates). VIVEbiotech’s facilities have a surface of more than two thousand square metres, with the possibility to expand. Our aim is to adapt to your own requirements from a technical and timeline perspective.
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Name · Wood (formerly Amec Foster Wheeler) Address/P.O. Box · 15 Justice Mill Lane Postal Code/City · Aberdeen AB11 6EQ Country · United Kingdom Contact Person Telephone Fax Email Address
· · · ·
Marco Bolognini (Milan, Italy) +39-024486-6656 +39-024486-6604 marco.bolognini@woodplc.com
Contact Person Telephone Fax Email Address
· · · ·
Hendrik Pantlen (Basel, Switzerland) +41-61-227-9481 +41-61-283-2201 hendrik.pantlen@woodplc.com
Internet Website Social Media Number of Employees Founded (year)
· www.woodplc.com · FL I · 55,000 · 1848
Areas of Activity · l Consulting l Engineering l Process systems l Project delivery l Commissioning l Qualification + validation l From feasibility studies to full EPCMQ provider Annual Turnover · Over $10 billion
Who we are Wood (formerly Amec Foster Wheeler) is a global leader in the delivery of project, engineering, and technical services to energy and industrial markets, operating in more than 60 countries and employing around 55,000 people, with revenues of over $10 billion. We provide performance-driven solutions throughout the asset life-cycle, from concept to decommissioning across a broad range of industrial markets: pharmaceuticals, biotechnology, environment and infrastructure, oil & gas, chemicals, power & process, clean energy, mining, and general industrial sectors. We strive to be the best technical services company to work with, work for, and invest in.
A specialist in pharma solutions Wood provides a broad range of services for the pharmaceuticals, biotechnology, and healthcare markets: process design (URS preparation, process simulation, equipment specification); consultancy (GMP audit/GAP analysis, assistance with site selection, site master planning, feasibility studies, conceptual design); engineering & construction (basic design, detailed engineering, project management, project control, procurement, FAT, SAT, risk assessment, construction management) and qualification/validation, commissioning, and start-up. The solutions that we offer meet stringent industry regulatory requirements, are economically and environmentally sustainable, and create value for our customers. We have successfully completed EPCMQ assignments from small-scale projects to major developments, in many countries around the world. Our ability to service the needs of our clients comes from our culture, which is focused on process-driven facilities. Our process engineers, working closely with our facility design, process automation, piping design, pharmaceutical systems, and validation groups, efficiently translate our customers’ needs into an optimal manufacturing process and facility design in compliance with all applicable cGMPs, codes, regulations,
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and standards. We provide sound, cost-conscious engineered solutions for our customers’ processing and manufacturing needs. We work with several of the world’s top drug manufacturers, including AstraZeneca, Roche, GlaxoSmithKline, Pfizer, Novartis, MSD, Sanofi, Bristol Myers Squibb, TEVA, Regeneron, Bracco, Lonza, CSL, and others. We have designed, built, and validated facilities for compliance with the code of Good Manufacturing Practice (cGMP) in USA, in Europe (Germany, Switzerland, Belgium, France, Italy, Russia), Turkey, Egypt, Saudi Arabia, UAE, China, South Korea, Singapore, Malaysia, Thailand, Australia, and New Zealand. Our project and design documentation is tailored to suit pharma regulatory requirements, ensuring that compliance is maintained at all times.
An extensive track record We have an exensive and proven track record of successful project delivery in: ·· Bulk Chemical (API) plants (high potent APIs, antibiotics, herbal/animal sources extracts, sterile bulk APIs) ·· Biotechnology plants (viral/bacterial vaccines, recombinant therapeutic proteins, plasma fractions, transgenic proteins, antibiotics) ·· Formulation, fill/finish and packaging plants (sterile injectables (LVP/SVP), oral solids/liquids, topicals, freeze-dried forms, inhalations) ·· R&D and pilot plants (research labs, biocontained labs, kilolabs, pilot plants, animal houses, auditoriums/conference facilities, QA/QC labs) ·· Other production support functions, such as warehouses and material handling systems, utilities plants, etc. ·· Medical devices manufacturing plants
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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 Frederik Walter +49-521-96989-200 +49-521-96989-201 info@xell.ag www.xell.ag
IQ
> 25 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 media 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 media 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. For various cell types … ·· CHO ·· HEK / human ·· BHK, MDBK, MDCK ·· Hybridoma … and for different applications: ·· Transient and stable gene expression ·· Biopharmaceutical and vaccine production ·· Batch, fed-batch and perfusion processes
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Analytical 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. Further 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)
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Name · Yumab GmbH Address/P.O. Box · Science Campus Braunschweig-Süd Inhoffenstr. 7 Postal Code/City · 38124 Braunschweig Country · Germany Contact Person · Dr Linda Kirchner Telephone · +49-531-481170-0 Email · info@yumab.com Website · www.yumab.com Social Media · I Number of Employees · 20 Founded (year) · 2012 Type of Laboratory · S1 | S2 Areas of Activity · l Discovery & development of recombinant fully human antibodies l Antibody libraries l Engineering & humanization l Drug development l Professional R&D services l Flexible licenses & license options with low entry costs for academic labs & biotech startups Request for · Yumab seeks collaborators and clients Further Collaborations in pharma, biotech, and diagnostic industry and research, who need a reliable partner in early stage antibody development and the benefits of fully human and recombinant antibodies
YUMAB provides discovery and development of fully human antibodies for clients and partners worldwide. In little more than five years, YUMAB has become a global player in human antibody discovery and development, and is now a driver of the general trend in the immunotherapy space toward the use of fully human antibody for therapeutic applications. The versatile technology platform and outstanding expertise make YUMAB the partner of choice for the generation of human antibodies optimized to the client’s needs in any kind of development program, at any stage, and with the properties needed for any immunotherapeutic strategy.
YUMAB® platform: fast & reliable The YUMAB® platform delivers fully human antibodies closest to natural germline among those on the market using fast and reliable in vitro discovery technologies. YUMAB’s highly diverse, human antibody libraries contain up to 1011 natural antibody sequences with specificities to all types of antigens. Unlike animal derived, chimeric, humanized, or synthetic antibodies – each YUMAB® antibody sequence has been shaped in the human body, which maximizes epitope diversity while minimizing immunogenicity and potential adverse effects in clinical development. Our vastly improved technology is also efficient for rare and difficult target antigens and directly optimizes properties such as affinity, stability, or interspecies X-reactivity during the early discovery process. First antibody candidates are already identified after only 4–8 weeks and are highly developable into all types of antibody drug formats such as full-length IgGs, Fabs, scFvs, bispecifics, CARs, fusion proteins, and ADCs. YUMAB provides tailored service and partnering concepts to jump-start translation from research to drug development by affordable entry costs, no additional third party obligations, and flexible licensing options.
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yumab
YUMAB at a glance
DISCOVERY
DEVELOPMENT
RESEARCH
Ultra-fast antibody discovery ·· Natural fully human antibody sequences from superior, universal, close-to-germline libraries ·· Direct, targeted in vitro selection on cells within 4–8 weeks ·· No unnecessary animal use, low toxicity & immunogenicity by design Efficient antibody lead development ·· Fully human, close-to-germline antibody candidates ·· All antibody drug formats, all therapeutic indications ·· Robust & fast process with high success rates Advanced research ·· Versatile, universally applicable technology ·· Smooth translation from bench to bedside ·· Innovative research & diagnostic tools Flexible services, collaborations & partnering ·· CRO: fee-for-service projects & flexible license options (low entry costs) ·· Collaborative & partnered development ·· Out-licensing of internal lead candidates
FULLY HUMAN ANTIBODY DISCOVERY PLATFORM UDSLG ɌUREXVW ɌUHOLDEOH
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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 NET WORK
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
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VOLUME 8
2018
8th European Biotechnology Guide
European Biotechnology Guide Science & Industry
ISBN 978-3-928383-66-0
European Biotechnology NET WORK
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