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International Pharmaceutical Industry

Supporting the industry through communication

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Outsourcing & Innovation Supplement 2017/2018


Contents

International Pharmaceutical Industry

Supporting the industry through communication

02 – 03 ABBVIE

04 – 05 ABZENA

06 – 07 BRUSSELS

08 – 09 EUROFINS

10 – 11 FISHER

12 – 13 GERRESHEIMER

14 – 15 HGF

16 – 17 MIKRON

18 – 19 NEMERA

20 – 21 OWEN MUMFORD

22 – 23 SGD PHARMA

24 – 25 VETTER

26 –Kipfenberg 27 WESTROCK

28 – 29 WICKHAM

Outsourcing & Innovation Supplement 2017/2018

DIRECTORS: Martin Wright Mark A. Barker BOOK MANAGER: Anthony Stewart anthony@ipimedia.com BUSINESS DEVELOPMENT: Alessia Giangreco alessia@pharmapub.com PRODUCTION ASSISTANT: Virginia Toteva virginia@pharmapubs.com DESIGN DIRECTOR: Jana Sukenikova www.fanahshapeless.com FINANCE DEPARTMENT: Martin Wright martin@ipimedia.com RESEARCH & CIRCULATION: Orla Brennan orla@pharmapubs.com COVER IMAGE: iStockphoto © PUBLISHED BY: Pharma Publications Unit J413, The Biscuit Factory Tower Bridge Business Complex 100 Clements Road, London SE16 4DG Tel: +44 (0)20 7237 2036 Fax: +44 (0)01 480 247 5316 Email: info@ipimedia.com www.ipimediaworld.com All rights reserved. No part of this publication may be reproduced, duplicated, stored in any retrieval system or transmitted in any form by any means without prior written permission of the Publishers. Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright. 2017/2018 PHARMA PUBLICATIONS

30 – 31 WOOLCOOL

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 1


ABBVIE FERMENTATION TECHNOLOGY AND CONTRACT/TOLL MANUFACTURING AT ABBVIE IN NORTH CHICAGO, IL

With over 65 years of experience in chemical and pharmaceutical fermentation, AbbVie Contract Manufacturing is a global leader in microbial fermentation. We offer a broad range of world-class fermentation development services and have a long-standing history of high quality commercial supply.

liquid/liquid extraction and filter presses, and we have large-scale purification equipment including chromatography, crystallisation and distillation. Our finishing operations include blender and fluid-bed drying, milling, blending and bulk packaging into a variety of containers.

Abbvie Contract Manufacturing has extensive experience and capacity across a wide variety of organisms including streptomycetes, actinomycetes, yeast, fungal, E. coli, and bacillus. Our expertise also includes fermentation with genetically modified organisms. AbbVie also is a multi-product approval facility and can manufacture products for a wide variety of industries, including pharmaceutical, agricultural food, nutriceutical, enzymes and chemical.

Our site infrastructure includes aerobic and anaerobic wastewater treatment. Large-scale utilities include on-site steam generation, rail access for bulk storage, access to large quantities of cooling water and chillers and dual-sourced electrical supply in case of emergencies.

What sets AbbVie apart is our proven ability to consistently meet delivery commitments thanks to our unparalleled microbial fermentation expertise and know-how, backed by an established site infrastructure to facilitate production on our 70-acre facility in North Chicago, Illinois. Fermentation Development Services When engaging in contract manufacturing projects for our clients, we bring the same level of professionalism, expertise and passion, as we do with our own internal product development and commercialisation. We offer support for products early in development including inoculum, fermentation and downstream process development and optimisation, strain improvement via classical and recombinant techniques, R&D and master cell bank creation and analytical method development and validation. AbbVie also supports later stage products including technical transfer of existing processes and optimisation to AbbVie’s manufacturing assets, analytical method transfer and scale-up to large-scale commercial manufacturing. To aid our customers in cost-efficient fermentation development, our plant includes 88 pilot scale fermenters (30 L working volume) which are an effective means to drive development, transfer and continuous improvement programmes. The pilot plant also has six 750 L fermenters, if a slightly larger scale is required. The pilot plant utilises the same process analytical technology (PAT) and process control systems as at the commercial scale pilot to design, analyse and control the manufacturing processes to ensure smooth scale-up and robust commercial processes.

Optional support functions also include sourcing team to identify, qualify, purchase and test raw materials; analytical and microbiological test labs on-site to release testing requirements. Strong Culture of Continuous Improvement Our strong culture of continuous improvement employs LEAN manufacturing principles. We hold ourselves accountable through Oliver Wight Class A Certification and apply key performance indicators (KPIs) to raise the bar on business processes and product metrics. We utilise continuous improvement tools, such as Kaizen, root cause problem-solving (RCPS) methodology, 5S, Six Sigma, and total productive maintenance programme to drive the best quality and cost profile for our clients. We share our client’s goals in striving towards efficiency and continuous improvement, while being environmentally conscious and socially responsible. We implement robust compliance and quality systems that have resulted in an excellent environment, health and safety record. As part of that commitment, we have implemented numerous environment, health and safety (EH&S) programmes to ensure pollution prevention and resource conservation, including water purification through reverse osmosis, on-site hazardous waste management, as well as anaerobic and aerobic basins for pretreatment of waste water. We welcome the opportunity to understand your needs. Please, visit AbbVie’s Contract Manufacturing website for more information at www.abbviecontractmfg.com.

Fermentation Commercial Services At commercial fermentation scale, we support every aspect of a commercial operation from raw material sourcing through bulk packaging and release testing. Our offering includes over 3000 m3 GMP fermentation capacities that vary in scale from 10m3 to 100 m3 in scale with supporting seed and feed tankage. We have dedicated cell banking services including freezer storage requirements (-80oC) with backup CO2. Our downstream recovery capabilities are very diverse and include harvest options of tangential flow filtration, decantation and disk stack centrifuges,

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CONTRACT MANUFACTURING Biologics | Potent | Drug Product | Fermentation Prefilled Syringe | Hot Melt Extrusion | APIs abbviecontractmfg.com

EXPERIENCE UNRIVALED

Fermentation

When it comes to delivering in fermentation, you need a CMO with unique knowledge that comes from 60 years of sector leadership.

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 3


ABZENA TECHNOLOGIES AND COMPLEMENTARY SERVICES ACROSS BIOLOGY, CHEMISTRY AND MANUFACTURING

Abzena is a life science group with headquarters in the UK, and chemistry and manufacturing sites in the US. Abzena’s complementary services and technologies in chemistry, biology and manufacturing, are applied to the selection, development and manufacture of better biopharmaceuticals. Abzena works with most of the top 20 biopharmaceutical companies and academic groups all over the world and is focused on enabling the development of better treatments for patients. Abzena’s technologies have enabled many of its customers to progress products (ABZENA inside), through to clinical development.    Abzena was created through the incorporation of Antitope, PacificGMP, PolyTherics and The Chemistry Research Solution (TCRS); all of whom now trade as Abzena. Abzena’s technologies and services are provided across its three sites as follows:   • Cambridge, UK (Babraham Research Campus) is the main location of our immunology, protein engineering, bioassays, bioanalytics, cell line development and bioconjugation activities. It is Abzena’s global headquarters, housing our commercial, finance and investor relations teams. •

San Diego, CA, USA is home to Abzena’s GMP biopharmaceutical manufacturing plant for Phase I and II clinical trials. Cell banking, process development, batch analysis, QC release and regulatory assistance are all provided at this site for both WAVE and single-use bioreactors.

Abzena’s team in Bristol, PA, USA has a strong background in synthetic organic chemistry and expertise in bioconjugation; providing research chemistry, antibody drug conjugate (ADC) services and manufacture of GMP reagents. The company’s manufacturing capabilities in Bristol is being expanded to enable the manufacture of bioconjugates to GMP standards.

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Chemistry at Abzena Abzena provides comprehensive chemistry services to pharmaceutical, biotech and agrochemical companies as well as governmental and academic research institutes. Abzena has a strong background in synthetic organic chemistry and extensive experience of custom synthesis. Abzena also provides comprehensive services and technologies to enable better biopharmaceuticals

Custom Synthesis

Protein/BioNMR Services

Abzena’s team of experienced organic chemists produce a variety of complex molecules at mg to kg scale. Common requests include: • Chemical intermediates • Drug metabolites • Process impurities • Degradants • Reference compounds • Preclinical drug candidates • Bioconjugates • Toxic compounds and potent substances

Abzena provides protein BioNMR spectroscopy to obtain information about the structure of peptides, proteins, and their complexes.

Analysis and Characterisation Abzena’s labs are equipped with an array of analytical and preparative HPLC equipment and mass and NMR spectrometers. This enables extensive analysis and characterisation of ADCs and complex organic compounds.

Start your project today. Visit www.abzena.com www.ipimediaworld.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 5


BRUSELS AIRPORT THE PREFERRED EUROPEAN PHARMA GATEWAY

Belgium’s Key Markets Belgium is well-known for its large share of worldwide export and import for pharmaceuticals, perishables and automotive. Brussels Airport and its partners provide high-quality infrastructure and processes for these important market segments, such as temperature-controlled warehouses and GDP complaint handling procedures. Brussels Airport Located at the crossroads of Europe, Brussels Airport offers fast connections with other major airports and direct access to a dense road network. Central Location and Long Haul Brussels Airport is centrally located in the most important economic area of Europe, where 60% of GDP is done. Next to the existing operation of their full freighter airlines, Brussels Airport has seen fast growth in terms of long-haul flights, resulting in additional direct connections in their network. Major Full-freight and Distribution Hub Brussels Airport is an important cargo hub and a leading gateway for the transportation of pharmaceuticals and other time- and temperature-sensitive goods. Brussels Airport is the most strategic location in Europe, reflected by its role as a valued European distribution hub, an ideal location for storage, handling and shipping of high-value and time-sensitive products. A Trustworthy Operating Base Brussels Airport is characterised by a proven coordinated approach between all involved partners, resulting in an efficient inbound and outbound cargo process. At Brussels Airport, the handling companies provide specialised services for nichemarket handling: • • • • • •

Pharmaceuticals High-value goods Live animals Perishables Dangerous goods Outsized cargo

an innovative, own invention. This refrigerated transporter is especially designedned for the transport of temperature-sensitive products between storehouses and aircraft on the tarmac. The “airside pharma transporter” is a trailer on which an insulated cool box is installed. What is really innovative is the technology that allows the temperature and location of the refrigerated transporter to be monitored in real time. 3. A Community-driven Approach Brussels Airport stimulates the cargo community by supporting a platform where all stakeholders at Brussels Airport can lobby, network, organise trainings, etc. This platform, named Air Cargo Belgium, is unique and offers great value to the cargo community and increases the efficiency of the air cargo chain. 4. Cloud-based cargo community platform Brussels Airport is also working on a cloud-based cargo community platform based on big data management: BRUcloud. BRUcloud will offer logistical solutions like statistics, slot and gate management, pharma shipment dashboard via different easy-to-use apps.

4 innovations at Brussels Airport: From idea to implementation: 1. World’s First CEIV Pharma-certified Airport Community For reliable and transparent transportation of your pharmaceuticals, Brussels Airport is your ideal partner, with the highest concentration of CEIV Pharma-certified companies and specialised staff in Europe. You have a choice of CEIV Pharmacertified partners and regulator-approved partners at Brussels Airport for fast, reliable, safe and secure handling of your pharmaceuticals. 2. The Airside Pharma Transporter Bringing the unbroken cool chain to the next level, Brussels Airport has developed the “airside pharma transporter”-

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EUROFINS GLOBAL BIOPHARMA PRODUCT TESTING WITHIN YOUR REACH

facturing expenditures by strategically engaging them to meet their unique outsourcing needs. As your project progresses to further enhance open dialogue and assist your decision making, we provide timely and secure access to comprehensive laboratory information through our innovative, 24-hour online data access tool, LabAccess.com. As the largest international network of harmonized 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, harmonized 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 harmonized 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 meters and facilities located in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, India, 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. Further, we have teams of scientists placed at more than 70 client facilities worldwide through our award-winning Professional Scientific Services® (PSS) insourcing program. Experience Our Expertise We offer complete CMC Testing Services for the Bio/ Pharmaceutical industry, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology.

Comprehensive Services We offer the flexibility to manage your testing programs more efficiently through your choice of three unique service models, including our award-winning Professional Scientific Services® (PSS), Full Time Equivalent (FTE) or traditional feefor-service. You can choose the best, most cost-effective service solution for your project goals. Our breadth of services includes: • • • • • • •

• •

Method establishment, including method development, feasibility, optimization, cGMP qualification and validation, as well as verification of compendial methods Comprehensive stability and release programs for clinical and marketed products Complete biochemical and chemical characterization and microbial identification Raw material and excipient testing (USP/NF, EP, JP) Production and non-production cell banking including full characterization Lot release/unprocessed bulk testing Process/facilities validation, including viral clearance, residual impurities testing, extractables & leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection Consulting/protocol writing GMP Manufacturing

Eurofins BioPharma Product Testing Avenue Herrmann Debroux 48, BE-1160 Bruxelles, BELGIUM Telephone: +32 2 766 16 20 E-mail: pharma@eurofins.com Website: www.Eurofins.com/Biopharma

International Presence Means Global Regulatory Compliance Operating under the same strict quality procedures, our laboratories offer a broad range of methodologies under GMP authorization, ISO 17025 accreditation and ISO 9000 certification, and all analysis are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP) and Japanese Pharmacopeia (JP), as well as specific customer methods. Collaboration Drives Cost-Effectiveness Our fundamental philosophy is to help clients efficiently allocate their research and manu-

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Largest scope of global services.

Sharpest focus on data integrity.

BioPharma Product Testing www.eurofins.com/biopharma

From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance. As we have grown to become the world’s largest network of GMP product testing labs, we continue to uphold our founding promise of personal service and impeccable quality. When the world awaits your product, choose the lab that provides complete capabilities and rigorous quality systems you can trust.

Comprehensive GMP Testing Services

Flexible Service Models

Global Facilities

Method Development & Validation • Release Testing • Stability Testing & Storage

Fee For Service (FFS)

Australia

France

Italy

Sweden

Full-Time-Equivalent (FTE)

Belgium

Germany

Netherlands

Switzerland

Professional Scientific Services® (PSS)

New Zealand UK India Canada INTERNATIONAL PHARMACEUTICAL INDUSTRY 9 US Spain Ireland Denmark

Cell Banking Services Virology Services Facility & Process Validation •

Chemistry Biochemistry Molecular & Cell Biology Microbiology www.ipimediaworld.com Raw Materials Testing • Primary & Secondary Package Testing •


FISHER CLINICAL SERVICES HELPING CUSTOMERS DELIVER AN EFFICIENT AND RISK CONTROLLED CLINICAL SUPPLY CHAIN WORLDWIDE. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivalled expertise. Fisher Clinical Services is a leading global provider of clinical supply chain services. With a network of 21 cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management, including clinical supply optimisation, comparator, co-medication and ancillary supply sourcing, packaging, labelling, distribution, storage through to returns and destruction. Our teams are committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. We offer unparalleled guidance and full logistics support across all types of clinical programmes and projects. Fisher Clinical Services is a part of Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of more than $20 billion, we have more than 65,000 employees and serve more than 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. www.fisherclinicalservices.com

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From Pack to Patient

We Deliver On Time & In Full. fisherclinicalservices.com

With unwavering dedication to serving clinical research and patients around the world, Fisher Clinical Services recognizes how important it is to deliver clinical trial supplies to the right patient On-Time and In-Full. From the packaging and labeling floor to a facility within our global network and on to patients at investigator sites, our experts respond with flexibility, determination and a high quality mindset. Powered by consultative project management teams with an exceptional commitment to delivering end-to-end, global clinical supply chain services, we ensure that patients receive their medication on time! Contact Us. fcsinfo@thermofisher.com

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 11


GERRESHEIMER GERRESHEIMER IS A LEADING GLOBAL PARTNER

‌ to the pharma and healthcare industry. With our specialty glass and plastic products, we contribute to health and well-being. We have worldwide operations and our 10,000 employees manufacture our products in local markets, close to our customers. With plants in Europe, North America, South America and Asia, we generate revenues of approximately EUR 1.4 billion. Our comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

OUR PRODUCTS ARE IMPORTANT AND CONVENIENT SOLUTIONS FOR EVERYDAY LIFE.

Plastics & Devices The product portfolio of the Plastics & Devices Division includes complex, customer-specific products for the simple and safe administration of medicines, such as insulin pens, inhalers and prefillable syringes. Also included are diagnostics and medical technology products such as lancets and test systems, as well as pharmaceutical plastic containers for liquid and solid medicines with closure and safety systems. For the North American prescription retail market a complete line of regulatory compliant prescription containers for medication dispensing is available.

Primary Packaging Glass The Primary Packaging Glass Division produces glass primary packaging for medicines and cosmetics, such as pharma jars, ampoules, injection vials, cartridges, perfume flacons and cream jars.

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Gx® Glass Vials Highest quality – advanced technology | Superior cosmetic and dimensional quality | Latest­generation machines | Standardized converting processes

www.gerresheimer.com

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HGF GLOBAL EXPERTISE FROM A EUROPEAN BASE

HGF Ltd is one of Europe’s largest firms of IP specialists. The firm has over 160 patent attorneys, trade mark attorneys and IP solicitors and is one of only a few in Europe to offer clients a fully integrated IP solution. With 15 offices across Europe the firm’s geographic and technical reach will ensure HGF is well placed to represent clients in European trade mark, patent, design and IP law matters post Brexit. HGF offers all the services one would expect from European patent and trademark attorneys and IP solicitors, but it is the firm’s dynamic approach to oppositions and appeals, strategic portfolio development and acquisition due diligence experience that distinguishes HGF within the IP marketplace. Key services • • • • • • • •

Patents Trade Marks Oppositions and Appeals Copyright Design Rights Due diligence and Freedom-to-Operate Strategy Law

HGF’s passion is Innovation. The firm’s team of thought leaders are experts in your industry and work in partnership with you to ensure success. Through listening to your needs and talking to you we understand your objectives, timescales and budget to give you the advice and strategies for success. Specialist teams The firm has dedicated teams of technical experts working across key industry sectors. Our specialist teams include: Life Sciences This team includes technical experts advising on AgBio, Personalised Medicine, Biologic Therapeutics, Stem Cell Technologies, Industrial Biotechnology, Bacteriophage, and

Gene Editing Technologies. The depth and breadth of HGF’s life science team’s collective experience means that we can not only demonstrate a long-standing commitment to serving the life science industry in an array of high profile matters, but also enables us to provide our clients with commercially relevant strategic advice on the most current issues affecting the industry. Team members can boast of having defended three of Myriad Genetics’ European breast cancer diagnostic (BRCA gene) patents in opposition proceedings, and opposed key patents in the field of recombinant antibody production for Eli Lilly, Pharmacia and Boehringher Ingelheim (the so-called “Boss” and “Cabilly” patents), and also of providing the industry with strategic up-to-the minute advice as the patent position develops with respect to CRISPR technologies. Chemistry – This team covers all areas of the chemical and pharmaceutical industry, including advanced materials, nanotubes, nanoparticles, semiconductors, medical chemistry, drug discovery, pharmaceutical formulations, advanced drug discovery. The team also has significant experience advising on SPCs, patent term extensions and regulatory data exclusivity. Electronics – This team handles work including microelectronic systems and devices, microprocessor architecture, telecommunications systems, electronic surveillance and microwave technologies. Engineering and physics – This team works in fields including mechanical and electromechanical devices, automotive, aerospace, medical devices propulsion systems, nuclear engineering, surgical instruments, manufacturing technology, power tools, road and bridge construction and oil drilling

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HGF technology. The energy market is served in full by a dedicated team based in Aberdeen. How is this achieved? Firstly, by consistently searching for and recruiting talent. The fact that HGF’s attorneys are technically proficient in their respective specialist areas is a prerequisite. The firm, however, look for more. HGF know that our clients not only expect patent advice based on a sound understanding of the underlying technology, but also require advice to be provided in a clear and commercially relevant manner. HGF’s attorneys are committed to understanding the specific goals and challenges of the sector of Life Sciences that each of our clients operate in. We of course learn much of this directly by working closely with and listening carefully to our client’s. Some of HGF’s attorneys are recruited directly from industry and therefore bring with them a good understanding of many sectors. Additionally, we make a commitment to engage with industry at large by attending key sector events where we deliver workshops and masterclasses, whilst at the same time learning more about the sector. HGF also hold an annual “IP in Healthcare Conference”; bringing together clients in the life sciences to discuss current technical and legal issues, along with invited guests with particular insights into these issues. IP law relating to the life sciences has developed over recent years almost as fast as the technology. The firm of course have regular in-house meetings to keep each other abreast of such developments. Perhaps, however, the best way we keep on-top of these developments is by constantly being involved with challenging case-work for many of our clients that work on cutting-edge science and that requires innovative legal solutions. HGF’s life science team are of course only part of the professional expertise within HGF that can come together to best support a client. For example, in many cases the life science team will share their understanding of commercial developments associated with a client with our trade mark team to ensure that such an understanding can be used to keep the brand strategy relevant to that client. The firm frequently work on projects with our transactional and litigation legal team. As more and more of the work we see involves combinations of technologies, we are used to pulling in members of other patent teams within HGF so as to form a multi-disciplinary team. This is

most common with members of our pharmaceutical chemistry team; with many of them having been recruited directly from large-pharma companies, such support can be very relevant to our life science clients. However, we also often collaborate with our colleagues that focus on MedTech, material chemistry and electronics. As many of our clients in the life sciences are multi-national corporations, HGF are aware of the particular challenges associated with efficiently prosecuting large multi-national patent portfolios, whilst keeping them relevant to the business. The firm have also however found this experience invaluable when advising SMEs as they grow or prepare for acquisition, and to academic institutions as they seek commercial collaborators. As a consequence of our commitment to provide technically proficient, pragmatic commercially relevant advice to our life science clients, you can be assured that you will be directed to an attorney that will understand the challenges and goals of your business.

For more information, visit www.hgf.com or contact us at: HGF Limited 1 City Walk, Leeds LS11 9DX Tel: +44(0) 1132330100 Email: marketing@hgf.com

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MIKRON MANUFACTURER OF ASSEMBLY AND TESTING SOLUTION

Mikron Automation is the leading partner for scalable and customised assembly systems – from the first idea to the highest performance solutions. Mikron’s expertise and proven track record guarantee the most productive solution to assemble customers’ products at each stage of the life cycle.

Mikron produces a set of documentation to support customers in their validation process. On each site, Mikron has a dedicated and skilled team with medical project expertise to support the project team from design to delivery. Customer Service After installation, our customised training and production assistance introduces your people to the feel and function of the new system. This accelerates your productivity increases, by reducing the personnel learning curve. Our support continues with remote maintenance tools, a service hotline, and the expertise of our technicians who arrive at your site to personally provide support throughout the entire service life of your assembly solution. These Specific Medical Customers Trust Mikron (Due to confidentiality, we cannot show an exhaustive list of our customers) 3M Health Care, Aerogen, Alere, ARaymond Life, Bausch & Lomb, B. Braun Medical, Bang & Olufsen Medicom, Bespak/ Consort Medical plc, Aptar Group, Eli Lilly and Company, Forteq, Gerresheimer, GlaxoSmithKline, Innovata Biomed, Molex, Novo Nordisk, Nemera, Nypro, Oechsler, Pfizer, Schott, Sanofi, Tech Group, Teva Pharmaceuticals, Vygon, Ypsomed

Mikron Automation: The Assembly Solution for Pharmaceutical and Medical Devices Mikron Automation continuously innovates to supply the best automated assembly and testing solutions for devices such as inhalers, pen/auto-injectors, catheters, e-devices, wearables, POC and molecular diagnostics. Mikron’s core competencies are the use of highly standardised manual, semi-automatic and fully automatic modules through its Mikron G05 and Mikron EcoLine platforms, and its expertise in complex process integration. Mikron adds value with the use of Polyfeed, the flexible feeding system, and the Tray Handler, for loading and unloading parts from trays.   The solutions operate at speeds of up to 100 cycles/minute with outputs from four up to 400 parts/minute. The entire family of Mikron products takes into account the special conditions for cleanroom ISO 7 applications. The basic machine hardware and software is pre-validated to GAMP 5 and 21 CFR 21, part 11 standards.   Pharma and Medical Competencies The pharmaceutical and medical device industries are governed by exceptionally stringent regulations and production processes which need to be verified by means of strict procedures. To meet these specific needs, Mikron offers full qualification support in accordance with GAMP 5. Specific emphasis has been put on ergonomics and cleaning of tooling to meet the GMP norms.

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About Mikron Automation Mikron Automation is headquartered in Boudry (Neuchâtel), in a region that is regarded as the heart of the Swiss watchmaking industry. To date, Mikron Automation has installed more than 3000 assembly and testing systems worldwide. Its international customers operate in the following industries: pharma/medtech, automotive supply, electrical/electronics, consumer goods and construction/building. Mikron Automation employs around 650 people at its sites in Boudry (Switzerland, headquarters), Berlin (Germany), Denver (USA), Singapore, and Shanghai (China). At a glance • Number of employees: 650 • Sales in 2016: CHF 140 million • Experience: 40 years • Customers worldwide: 250 • Systems installed worldwide: over 3000 • Projects: more than 60 per year • Delivery times: four to 12 months Mikron Automation Address: route du Vignoble 17 / 2017 Boudry / Switzerland Tel: +41 32 843 11 11 Fax: +41 32 843 11 12 Web: www.mikron.com/automation Key Contact: Jean-François Bauer / Head of Marketing & Business Development Mikron Automation Email: mbo@mikron.com

IPI Outsourcing & Innovation Supplement 2017/2018


THE AUTOMATION SOLUTION

MIKRON AUTOMATION IS YOUR PARTNER FOR SCALABLE AND CUSTOMIZED ASSEMBLY SYSTEMS – FROM THE FIRST IDEA TO THE HIGHEST PERFORMANCE SOLUTIONS

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WWW.MIKRON.COM

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AMERICA: DENVER (USA) - ASIA: SINGAPORE , SHANGHAI (CHINA) - EUROPE: BOUDRY (SWITZERLAND)


NEMERA WORLD LEADER IN THE DESIGN, DEVELOPMENT & MANUFACTURING OF DRUG DELIVERY SOLUTIONS

Nemera’s expertise covers five modes of delivery:

Nemera is a World Leader in the Design, Development and Manufacturing of Drug Delivery Solutions for Pharmaceutical, Biotechnology and Generics Industries. Ophthalmic Nemera offers a multidose closing tip system, Novelia®, which avoids the need for preservatives in the drug and prevents bacterial contamination over the duration of treatment. Novelia® is an innovative, user-friendly, preservativefree multidose eye dropper with a precision blue tip, which is commercialised for both medical devices and prescription drugs. It is recognised and appreciated by patients today across four continents. It is useful for applications for dry eyes, glaucoma, allergies and more. Nasal, Buccal, Auricular Nemera offers an extensive range of metered pumps and valves, compatible with a wide choice of actuators in different shapes and fitments for nasal, buccal and auricular delivery. SP270+ is the new optimised spray pump engine for ear, nose and throat in terms of performance and raw materials. Advancia®* offers a new alternative to improve treatment compliance in an increasingly demanding nasal spray market. Designed to be a step ahead of today’s pumps, Advancia® is based on a new system combining user-independence and anticlogging features in one single system. Parenteral Nemera leverages decades of manufacturing and development experience in the parenteral device segment to offer patients premium products and customers a complete service. Nemera has developed Safe’n’Sound®, a fully passive safety device for prefilled syringes to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medications, and individuals who assist self-injecting patients, from accidental needlesticks. Not only does Safe’n’Sound® improve users’ safety and injection conditions, but also the device complies with the recommendations of the World Health Organization and the EU Council Directive 2010/32/EU.

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Nemera developed also Safelia®, a breakthrough technology of auto-injector. This new generation of two-step auto-injector for fluid and viscous injections has been designed to ease patient self-injection experience and to deliver, in glass syringes, fluid formulations to challenging dugs (viscous, sustain released, concentrated, in subcutaneous or intramuscular layers, in large volumes…) Dermal and Transdermal Nemera’s dermal delivery devices have been designed to ensure patient compliance thanks to precise and consistent dosing, which is critical, especially when applying formulations for systemic treatments. Sof’Bag® is a high-performing airless pouch system for dermal and transdermal applications. Sof’Airless XS is a protective mini-airless system for small-dose applications and sampling. Sof’Airless XL is a customised dispenser for higher dose applications. Pulmonary Consistency and reliability are critical for respiratory patients. Nemera has a recognised expertise in the development and manufacturing of respiratory drug delivery devices, such as dry powder inhalers (DPIs), pressurised metered dose inhalers (pMDIs) and dose counters. www.nemera.net For more information, contact us: information@nemera.net *The Advancia® innovative project is cofinanced by the European Union. Europe is committed in Normandy with the European Regional Development Fund (ERDF).

IPI Outsourcing & Innovation Supplement 2017/2018


Patient-focused drug delivery devices Drug Delivery Devices Innovative developments Customized solutions GMP contract manufacturing

www.nemera.net information@nemera.net Phone: +33 (0)4 74 94 06 54

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OWEN MUMFORD PUTTING LIFE INTO TECHNOLOGY

Vital Stats: Founded in 1952. Employees: 800 Key Personnel: Jarl Severn, Managing Director Global market served.

Key features • •

Who we are: Owen Mumford specialises in integrated design and build services from a broad range of self-injection platform devices for the pharmaceutical industry.

• •

From the first automatic lancing device to our patented selfinjection devices, with Owen Mumford you have access to unrivalled experience in designing, developing and delivering solutions to help you make adherence easier for patients. Device solutions With more than 30 years experience, your device is in good hands with Owen Mumford. From day one, we will guide you throughout the development process. At every step you will benefit from exceptional project management, quality processes, industrialisation and production for a smooth development and launch.

• •

UniSafe is designed without a spring, which means that the syringe barrel is unobscured, allowing the user to visually confirm the full dose has been delivered Improved end-user comfort with a larger, ergonomic plunger head and a smoother, more integrated finger flange resulting in a more integrated look and feel Prevention of accidental activation which can occur with traditional spring-based auto-injectors Passive needle retraction means that the device is safe as soon as the plunger is fully depressed Designed to work with standard, pre-fillable syringes Autoject® Micro

A true auto-injector with automatic needle insertion in a compact body Autoject® Micro is the next generation disposable autoinjector. Its compact design is the result of patented drive mechanism technology allowing true auto-injection in a more discreet package. This is designed to improve adherence by overcoming barriers to self-injection – whilst addressing your cold store and logistics costs.

Consultation We listen to your needs to determine the best solution, drawing on our experience of multiple primary containers, formulations and therapies. From simple brands of existing technology to wholly bespoke designs – we can help you achieve your goals.

Autoject® Micro is a disposable device, which can either be supplied fully assembled with your prefilled syringe or delivered to you in separate parts ready for final assembly at your facilities.

Design A multi-disciplinary team of professionally qualified experts ensures that design concepts meet your exact requirements. The thorough understanding of your end users’ needs includes the incorporation of human factors and ergonomics studies.

Develop A close collaboration between design, production and your own team will ensure your device is designed for manufacture while still keeping patient satisfaction in mind.

Deliver The production of your device is tailored to your needs – from low-volume hand assembly to high-volume automation. We are also licensed for the final assembly of combination products. Example of our new innovation are shown here... contact us for more information. UniSafe A springless passive safety device for pre-fillable syringes UniSafe is a springless, passive safety device designed to work with standard, pre-fillable syringes. This means nothing that touches the drug needs to change. UniSafe looks and works like a normal syringe.

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Key features

• • •

• • • • •

True auto-injection: needle is inserted and dose delivered at the touch of a button Concealed needle to reduce injection anxiety Sharps Injury Prevention: needle is hidden before and after use Protective cap and locking mechanism prevent accidental activation Activation button appears when device is unlocked and ready to use Audible and visual feedback at start and end of dose Convenient size for storage and portability Intuitive: use as a press-button or contact-activated device Large viewing window for easy viewing of syringe Ergonomic: oval shape and large grip detail on cap

Contact: Owen Mumford Ltd, Brook Hill, Woodstock, Oxfordshire OX20 1TU United Kingdom Tel: +44 1993 812021 Email: devicesolutions@owenmumford.com Web: www.omdevicesolutions.com

IPI Outsourcing & Innovation Supplement 2017/2018


How can taking something away make it more? Introducing the new UniSafe™ springless, passive safety device No spring means it’s safe, reliable and cost effective.

Come and visit us in Pharmapack in Paris at Stand B14 to find out more about UniSafe™

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 21


SGD PHARMA SGD PHARMA, INSPIRING CONFIDENCE Kipfenberg

SGD Pharma has a unique know-how and offers innovative and premium quality packaging solutions consistent with international pharmacopoeias. From design to manufacturing, our teams will accompany you in the development and the realization of your projects. SGD Pharma places the quality and safety of the patient at the centre of its concerns. All our manufacturing sites are totally dedicated to Pharmacy, certified ISO 15378. All our bottles are controlled and packaged in clean room ISO 8. SGD Pharma is implementing a quality policy both homogeneous and effective on all its sites of production, based on the respect of Good Manufacturing Practices. Our quality policy is based on the one developed by the pharmaceutical industry. Our clients are regularly associated with the development of our action plans. By deploying analysis and continuous improvement tools, very like our clients’, we ground in a sustainable manner of pharmaceutical culture shared by all. Thanks to this approach and our careful attentiveness known and recognized by our customers, we are able to meet with their requirements. In the drug industry more than elsewhere, the security of the supply chain is a vital element. We carry out every effort to ensure a continuous supply and protect the client and patient. SGD Pharma provides back-up solutions between its different manufacturing sites for all types of glass.

Saint-Quentin-La-Motte

Vemula

Center of excellence for molded glass Type I • A brand–new plant at state of the art, completed in 2016 • Experiences employees • ISO 8 clean room & ISO 15378 • Dedicated to parenteral and nasal products Dedicated to Type I, molded & tubular • Brand new facility, built in 2013 • ISO 8 clean room & certified ISO 15378 • 1 furnace for Type I flint & amber molded glass • Dedicated to parenteral products offering molded and tubular Type I vials and ampoules • NEW unit 5: Operational beginning of 2018 – Additional capacity for converting ampoules Center of excellence for Type II infusion bottles • Certified ISO 15378, 14001, 5001 & 18001 • ISO 8 clean room • Type II & III flint glass

Kipfenberg

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Sucy-En-Brie

Zhanjiang

Center of excellence for Type III amber bottles • A 100 years experienced plant • ISO 8 clean room & certified ISO 15378 & 50001 • Type II & III – flint and amber glass • Dedicated to oral and parenteral applications Center of excellence for infusion bottles in Asia • ISO 8 clean room & certified ISO 15378 • Type II & III flint glass • Dedicated to infusion bottles, injection vials & Chinese medical products • Beauty Division

Finally, our overall implementation and our vast distribution network allow us to be there for you wherever you need us. SGD Pharma’s New identity was Unveiled on Nov 2017 Simultaneously in All the Group Plants. All employees were given a presentation by the management on the group’s new mission, vision and guiding principles. The event was also a great opportunity to present the new visual identity with a modern and dynamic logo which reflects strength and unity. Our group’s mission, aligned with its DNA, is to improve and protect patient’s health by providing high quality, innovative and reliable primary glass packaging to our pharmaceutical customers. 5 guiding principles have been selected so that everyone can carry out this mission: Partner with the customers: We build long-term relationships with our customers, we are agile and responsive to customer’s need, we optimize customer experience by being reliable and transparent, we innovate in collaboration with our customers to improve our offering Commit to patient’s safety: We understand our critical role in delivering drugs to patients safely, we put the highest focus on the quality provided to our customers, we consistently apply GMP standards Work as one efficient team: We consider accountability, mutual respect and trust as foundations of our work, we transform local ideas into global projects by sharing best practices, we leverage the diversity of our people into one SGD Pharma culture Act responsibly: We are collectively responsible for employees’ safety, we put compliance & ethics at the top of our priorities, we minimize the impact of our activities on the environment Develop people & talents: We train, develop and invest in our people, we strive to create a positive work atmosphere, we recognize both leadership and expertise as career paths to grow in the company

IPI Outsourcing & Innovation Supplement 2017/2018


SGD PHARMA The new mission and the guiding principles both support an ambitious growth strategy and a long-term vision of SGD Pharma. The group’s will is to consolidate its leadership in the moulded glass market and grow in the tubular segment, to be recognized as the global partner of choice by its clients, to reinforce operational excellence and being acknowledged as a great place to work.

Lower Total Cost of Ownership – Better inspection at reception, inducing a reduction of wasted filled vials, and a better inspectability after filling

Best quality on the market – SGD Pharma is the only supplier worldwide offering these premium injection vials in Type II

In line with our new mission, SGD Pharma received, in 2018, the Best Employer label from the heavy industry and materials sector by Capital magazine (France). This label underlines the attractiveness of our employer brand, the cohesion of our teams and the group’s attention towards its employees.

Clareo is available in capacities of 20, 50 and 100ml in Type II and further developments are in progress. Clareo can also be available, on request, in Type III.

SGD Pharma, Successful in Innovation The mission of SGD Pharma is to improve and protect patients' health by supplying high quality, reliable and innovative glass primary packaging to customers in the pharmaceutical industry. Our commitment is to continuously innovate and to reinforce patient safety by improving the physical, chemical and cosmetic properties of our different types of glass. SGD Pharma introduces Clareo, its new premium range of molded glass vials in Type II, for injectable solutions. Clareo vials from SGD Pharma offer a combination of homogeneous wall thickness and superior cosmetic quality, which for molded glass Type II is unique in the market. The new range offers technical characteristics similar to the vials in the existing range and can replace them without any regulatory change. Once again, SGD Pharma demonstrates with Clareo its expertise in the control of manufacturing process of molded glass. •

Breakage rate reduction – Better distribution of the glass wall thickness (+15pts) and bottom regularity

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EZ-Fill-Sterile ready-to-fill molded vials Our goal, in partnership with Ompi EZ-fill® platform is to offer a complete range of sterile primary packaging to answer the expectations of pharma and biotech companies in ready-tofill solutions. •

More flexibility – its ready-to-fill format leverages the different container fill-finish processes by using a common multi-product line. By joining Ompi EZ-fill® platform, SGD Pharma adds new solutions in vials filling.

Less time to market – It is the perfect solution to be managed both during clinical trials and during the industrialization phase.

Increased quality and safety – Unique SGD Pharma Asolvex® Type I molded glass minimizes interaction risk. The specific design of the tray and the final packaging prevent the sterile molded vials from both particles and cosmetic aspects, reducing breakage during storage, transport and handling.

Reduced Total Cost of Ownership – It allows pharmaceutical companies to outsource their non-core activities, to lower footprint, to reduce costs related to personnel and utilities.

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VETTER A STRATEGIC PARTNER FOCUSED ON YOUR SUCCESS

Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges and vials. We are a family owned, independent company and do not manufacture our own drugs. Our focus is on providing highly skilled support and state-of-the-art manufacturing resources - from the initial phases of clinical development and regulatory approval process through successful product launch, commercial manufacturing, and life cycle management. We provide: • • • •

Vetter Development Service Vetter Development Service helps smooth the path to clinic with dedicated support for development, testing, clinical manufacturing, and regulatory approval. We help you integrate thoughtful, efficient life cycle solutions for long-term growth and success. We provide: • • • • •

Formulation support Process development Clinical trial manufacturing Analytical services Regulatory support

Vetter Commercial Manufacturing Vetter Commercial Manufacturing supports your injectable with more than 35 years of expertise in high-quality, state-of-the-art aseptic filling - and experience-based solutions that add value and increase efficiency.

Fill and finish Analytical services Regulatory support Product life cycle management

Vetter Packaging Solutions There are many factors to consider in the selection of your primary and secondary packaging materials. Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle. We provide: • • • • •

Customised packaging development Specialised technologies Proven platform technologies Packaging services Logistic services

Fast Facts: Vetter-at-a-glance • Headquarters in Ravensburg, Germany • Additional clinical development facility in Chicago, US • Sales offices for Asia Pacific in Singapore, Japan and South Korea • Approximately 4,300 employees • Worldwide specialist in the aseptic production of prefilled drug delivery systems • Global experience and expertise with regulatory authorities including FDA, EMA, PMDA(Japan), and RP (Germany), in multiple countries, including Canada, Russia, Brazil, Mexico, and Saudi Arabia • Numerous patents including technologies for protection against tampering and counterfeiting • Lyophilization (freeze-drying) and siliconization specialist Contact For international inquiries please contact +49-751-3700-0 or info@vetter-pharma.com. For US inquiries please contact +1-847-581-6888 or infoUS@vetter-pharma.com. Visit www.vetter-pharma.com for more information.

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IPI Outsourcing & Innovation Supplement 2017/2018


Do you know whom to trust with your complex compound? By the time your compound gets to clinical development, you’ve already invested years of painstaking work. Yet the next phase is filled with unpredictability and challenges. So what can you do to help smooth your compound’s path to clinic and beyond? With Vetter, you get the advantages of working with a partner who knows how to take your compound from preclinical to clinical to commercial manufacturing: ■

Expertise in the development of a broad range of drugs, including sensitive biologics

Technology, processes, and resources to achieve developmental milestones

Clinical manufacturing facilities in the US and Germany

When it comes to your injectable compound, turn to the partner trusted by top biopharmaceutical companies. Turn to Vetter.

Answers that work www.vetter-pharma.com www.ipimediaworld.com

US inquiries: infoUS@vetter-pharma.com • Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com • Japan inquiries: infoJapan@vetter-pharma.com • EU and other international inquiries: info@vetter-pharma.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 25


WESTROCK MULTI PACKAGING SOLUTIONS

WestRock’s Multi Packaging Solutions… World-class Pharmaceutical Packaging As a leading, trusted supplier of packaging products and services, we are focused on the unique needs of the healthcare industry. Our global footprint extends across Europe, North America, and Asia, with over 70 manufacturing sites in 14 countries. To service our global healthcare partners, 30 manufacturing sites are dedicated to healthcare packaging products and services. We offer an unrivalled range of printed products and services that include package design and engineering, sophisticated anti-counterfeiting measures, and supply chain solutions that create true value for our customers. We supply many of the world’s leading pharmaceutical companies as well as many more specialist niche businesses. A Global Reach with a Local Touch… MPS is intent on expanding its international network of strategically located facilities across the world. “Our aim is to introduce new products to market as quickly and cost-effectively as possible,” says Bobby O’Connor, Senior Vice President Sales Global Healthcare. “Naturally, we offer absolute security of production, providing customers with single - or multi-point service and the assurance of both multinational and local supply.” In Europe and North America, MPS is the leading pharmaceutical packaging provider, producing an unrivalled range of packaging components. Our investment in an extensive range of machinery – including offset litho, flexo and digital – provides a choice of technologies to cost-effectively manufacture a wide portfolio of business and support our range of product offerings. Now part of WestRock, we have expanded our geography, product offerings, and market penetration on a global scale. In Asia, our state-of-the-art facilities in China manufacture an extensive range of cartons, labels and leaflets. We employ innovative practices and systems to provide a high level of manufacturing security. We were also the first packaging manufacturer outside Europe to be certified to the exacting pharmaceutical manufacturing standard, PS9000. Borderless Quality Assurance Despite the fact that Multi Packaging Solutions provides a truly multinational service, our philosophy is actually founded on local capability and local supply. We can confidently satisfy stringent quality standards and offer single-source, multi-site solutions for all pharmaceutical packaging. All our global sites operate to the highest local standards and common quality standards and systems; many are accredited to ISO 9001: 2000 or PS9000, or operate to cGMP. Total Product Capability MPS provides its customers with an unrivalled range of printed

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products. In addition to folding cartons, labels and leaflets, we’ve introduced many new formats addressing both the legislative and consumer requirements of the sector, for example: re-sealable leaflet-labels; our unique Easipak™ leaflet-cartons; and creditcard-sized booklets. As part of WestRock, we can offer a range of innovative adherence packaging options, including child-resistant, tamper-evident and senior-friendly styles. We offer a broad range of specialist packs to improve packing line efficiencies, reduce SKUs and improve the way information is presented to consumers. These include combination products such as multiserts (leaflet plus leaflet, leaflet plus day-label, leaflet plus card, leaflet plus booklet) and banded leaflets. Our other pack formats include shelf-ready packs, rigid boxes, paper tubes, shaped-cartons – in fact, the list is endless. We continuously evaluate technical developments in both processes and materials. Our unmatched investment programme has benefited all our global operations. As well as new-generation production equipment, we are committed to product innovation to help our customers develop and extend their markets. Innovation for Tomorrow The MPS team is committed to next-generation product development. We strive to constantly improve the extent and quality of our production services, as well as pioneering creative solutions incorporating ground-breaking construction and finishing techniques. In collaboration with clients, we can develop and assess new packaging materials and designs, co-ordinate product trials and organise analytical testing, where required. We have also developed connected packaging solutions incorporating new technologies that offer the ability to communicate with the consumer. These can facilitate calendar alerts, send messages and provide instant access to websites – just a few examples of a new era dawning in packaging. Complete Systems and Solutions MPS supports its global manufacturing capability with impressive design facilities and optimised supply services. Using e-VMI systems, we aim to dynamically drive the rationalisation of stock and minimise obsolescence, as well as compressing lead times through collaborative planning. Our range of solutions combines the best of what we offer: innovative packaging design, seamless and secure manufacture, and a robust supply chain partnership. Our artwork management service, Cirrus, offers artwork creation and lifecycle management as well as packaging design, print and artwork consultancy. Cirrus can manage artwork at every stage, and offers a full, confidential service, providing independent technical advice, regardless of where the artwork is originated. Cirrus implements a quality system that conforms to the highest pharmaceutical standards for printed materials, with process maps and documented procedures provided for every production phase. Naturally, Cirrus is fully compliant to PS9000 and adheres to GMP standards. www.cirrus-artwork.com We offer all of this across an integrated supply network that stretches across North America, Europe and Asia. Contact Details: marketing@westrock-mps.com

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WICKHAM OVER 50 YEARS OF EXPERTISE IN GMP/GLP CONTRACT TESTING

As a GMP / GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries, maintaining only the highest standard of quality at all stages while providing rapid turnaround for both routine testing and bespoke one-off projects. Whether assisting a start-up company demonstrating proof of concept, or working with a global medical device manufacturer, our expert technicians recognise the importance of delivering an exceptional service by taking the time with every client to fully understand their individual requirements. Our Hoeford Point site, with approximately 4,000 square metres of space, is segregated into independent laboratory areas, providing a wide range of microbiology and toxicology testing services. We operate in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as well as to International Organization for Standardization (ISO) and International Conference on Harmonisation (ICH) guidelines. In addition to the discrete laboratories themselves, we also have dedicated facilities for sample booking and media preparation. Our sample receipt team utilises systems operating to FDA 21CFR part 11 which ensures safe handling and full traceability of samples, and the majority of the media used to test these samples is prepared and processed by our in-house media preparation department. At Wickham Laboratories, we operate a secure site, with an onsite security team 24/7. We are also equipped with a team of in-house qualified service engineers, enabling a self-sufficient facility without major service disruptions. Services Portfolio Microbiology Testing Wickham Laboratories has a fully equipped microbiology facility and our staff are knowledgeable in a wide range of medical device and pharmaceutical microbiology testing methods.

• Microbial identification, both rapid identification via MALDIToF (Matrix Assisted Laser Desorption Ionisation – Time of Flight) and traditional identification methods, including API, gram stain, microscopy, morphological analysis and presumptive biochemical tests • Microbial ingress testing • Microbial limits testing • Sterility testing (Steritest®, membrane filtration and direct inoculation methods) • Total aerobic microbial counts (TAMC) / total yeast and mould counts (TYMC) • Water testing Toxicology Testing We also have considerable expertise in toxicology testing, working with human and veterinary pharmaceutical and medical device industries to provide quality control of existing products, assistance with registration of new formulations and research into new medicines and technologies. Our toxicology services include: • • • •

Abnormal toxicity testing Rabbit pyrogen testing (RPT) Potency bioassays USP Class I-VI

We regularly perform microbiological testing for the pharmaceutical industry, conducting routine quality control analysis of a wide variety of pharmaceutical products for batch release into European and International markets. Our staff have also been involved in proof of concept development work for a variety of medical device types, in addition to the industry’s routine requirements of sterilisation and bioburden testing. Our microbiology services include: • • • • •

Absence of specified pathogens Antimicrobial efficacy testing Bioburden testing Biological indicator enumeration Environmental monitoring

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WICKHAM In Vitro Testing At Wickham Laboratories, we recognise the need to implement in vitro testing methods where ever possible, while maintaining the highest standard of scientific expertise in toxicology testing. As part of our commitment to reducing the need for animal testing and replacing it with non-animal alternatives, we have a dedicated in vitro research and development division. The main focus of this division is to establish new test systems for use within toxicology and develop in vitro or ex vivo methods to replace some of the testing currently carried out by our toxicology department. Our in vitro testing services include: • Monocyte activation test (MAT) • Bacterial endotoxin testing (LAL) • Cytotoxicity testing Supplementary to these core services, our skilled in vitro technicians are also familiar with a wide range of analytical techniques, including diagnostic tests such as ELISA (enzymelinked immunosorbent assay) and BCA (bicinchoninic acid assay), as well as the Western Blot test.

Consultancy Support In addition to laboratory and testing services, we offer global support and consultancy services relevant to a wide range of medical device and pharmaceutical development and manufacturing concerns including: • • • • • •

Cleanroom qualification Environmental monitoring assessments Process validation / identification of contamination sources Regulatory applications support Training on appropriate cleaning practices Validation of water systems

Wickham Laboratories’ long standing global experience in the contract testing industry means that there is rarely a problem that has not previously been encountered and resolved by our expert team. Accreditations Wickham Laboratories is assessed under the UK Good Laboratory Practice (GLP) Compliance Programme and complies with the principles and guidelines of Good Manufacturing Practice (GMP) with respect to contract analysis of human and veterinary pharmaceuticals.

Stability Storage and Testing As part of our comprehensive package of services, we now offer stability storage with several purpose-built stability cabinets currently onsite. Samples can be assessed under a range of storage conditions at 3, 6, 9 and 12 months as well as 18, 24, and 36 months for shelf life assessment.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) regularly inspect our facilities and quality systems for compliance.

These cabinets have undergone full qualification and are continually monitored for temperature and humidity via a hardwired system which is alarmed and monitored 24/7 with any temperature or humidity changes triggering an alert to our dedicated staff. Through a combination of our in-house capabilities and strategic partnerships with several preferred laboratories, we are able to offer the following stability indicating assays: • Level of active ingredient measurement • Physical attributes (colour, phase separation, caking, hardness and pH) • Preservative activity in multi-dose formulations • Sterility and bacterial endotoxin levels in parenteral products • Microbial limits testing including TAMC / TYMC counts, and absence of specified microorganisms

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For more information, visit www.wickhamlabs.co.uk or contact us via the information below: Contact Information Wickham Laboratories Ltd Hoeford Point, Barwell Lane, Gosport, Hampshire, UK PO13 0AU Tel: +44 (0) 1329 226600 Email: mail@wickhamlabs.co.uk

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WOOLCOOL PERFORMANCE PACKAGING. NATURALLY.

Pharma Innovation Woolcool is setting new standards in cold chain logistics for the distribution of highly temperature-sensitive pharmaceuticals, from livestock and human vaccines to insulin to Botox. Temperature-sensitive pharmaceuticals can be rendered ineffective if they are not maintained within their specific temperature range, which is a real challenge for complex supply chains and significant variations in global ambient temperatures. Woolcool, regardless of these fluctuations, will maintain the required temperatures within the insulated packaging, so whatever is going on outside becomes irrelevant. So real is the challenge, that in 2013 the European Commission published revised ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ to ensure stricter procedures and greater accountability throughout the supply chain. These new guidelines not only included tight temperature controls of refrigerated medicines in the cold chain (2°C to 8°C) but also controlled room temperature (CRT) products (15°C to 25°C). The UK government-backed Technology Strategy Board has recognised the potential of Woolcool as the solution to the supply chain challenge of these temperature-sensitive pharmaceuticals and funded further research and development specifically for this purpose. Woolcool has now been independently validated to the 2013 EU GDP standards required for approval by The Medicines and Healthcare Products Regulatory Agency (MHRA) to maintain internal temperatures between 2°C and 8°C for at least 72 hours. Several major players have already switched to Woolcool, including leading distributors of pharmacy, dental and veterinary suppliers as well as certain NHS hospitals.

Super Clever Woolcool are disruptive innovators and packaging pioneers who dare to do things differently, to do it better. We literally think out of the box to come up with our packaging solutions - designing and developing products to overcome the biggest problems with existing packaging and to meet specific needs of very different clients. And just because we work with wool, there’s nothing woolly about our packaging innovations. We’re experts and award-winners in professional packaging design and we put all our experience and expertise into developing products that are proven to really work, really well. We’ll always be leading the flock.

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Leading the Way Woolcool insulated packaging is not only simple in construction, its performance is superior to conventional materials. It’s a no-brainer really – wool is naturally the best insulation so what else would we choose to make the best insulated packaging? Obviously wool keeps things cosy but it’s actually much cleverer than that, because wool fibres are hygroscopic, which keeps temperatures amazingly stable and cool - nature’s very own smart fibre. Cleverer still are our own designers, who’ve harnessed these properties to make insulated packaging which outperforms leading alternatives on every level. Woolcool has been independently proven to keep contents consistently cooler, or at the critical temperatures, for longer than leading alternatives, in more versatile, flat-packed packaging which needs fewer ice packs and is naturally protective. Quite simply, Woolcool is the most practical and sustainable highperformance insulated packaging on the market.

Future Proof Our natural packaging solution isn’t just for today, it’s a gamechanger that will help future generations sleep well at night. Many companies have pounced on ‘sustainability’ as an easier option than proving real ‘green credentials’ or environmental benefits, but we don’t need to pull the wool over anyone’s eyes. Instead of making tenuous sustainability claims about products that really aren’t, we’ve simply come up with products that genuinely are, on every count. Wool is available in abundance worldwide. It doesn’t need a complex, chemical process to make it into insulation because it does this naturally. Our outer packaging is made from recycled and recyclable materials and the wool is compostable. Woolcool will not only stand the test of time long into the future, but brings businesses the added value of being the environmentally responsible solution that consumers, and the world, are crying out for.

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MARKET REPORT MANAGING RISK IN PHARMACEUTICAL GLOBAL SUPPLY CHAIN OUTSOURCING

To flourish and survive in today's competitive global marketplace, firms are increasingly focusing on their core competencies and turning towards outsource functions in which they possess no expertise to maintain effective cost structures and to improve their top and bottom lines. In today’s hypercompetitive global marketplace no one firm can go it alone and become successful in search of market opportunities in near real-time and cost-effective fashion because of lack of key talents and knowledge experience bases (Conklin, 1994). Due to few blockbuster drugs in the pipeline chain and competition from generics firms, the pharmaceutical firms are increasingly scrutinizing their operations to improve shareholders’ value and profit margins (Snee, 2006). In particular, the practice of pharmaceutical outsourcing has become more than ever a viable strategic business option to gain competitive advantage. Firms’ increasing focus on core competencies and the need to reduce cost are motivating them to turn to global outsourcing. This trend towards global outsourcing relationships has been strong in various types of firms and in different parts of the supply chain (Fill and Visser, 2000). It has been recognized as one of the eight most prominent factors playing a key role in the offing for superior supply chain performance (Carter and Narasimhan, 1996). And superior supply chain is one that enables a firm to optimize the value of internal activities and in turn creating collaborative partnerships that can lead to high value external activities (Lakhal et al., 2001). Pharmaceutical global supply chain outsourcing trends After many years of recorded growth and profitability, the pharmaceutical industry is challenging time. As a result, to remain viable they are looking toward new business model to improve their pharmaceutical supply chains and contain costs. And the new business model to accomplish that is global supply chain outsourcing. For example, estimate has it that the U.S. market for outsourced pharmaceutical manufacturing is expanding at the rate of 10 to 12% annually. The Pharmaceutical firms will continue to drive much of this growth as they outsource large number of products and services emerging economies in Asia. For example, the pharmaceutical industry is increasingly outsourcing its R&D to Asia in desperation to tame the rising cost. Indeed, global supply chain outsourcing represents one of the acknowledged organizational and industry structure shifts of the 21st century for the pharmaceutical industry. The pharmaceutical and biotechnology industry is outsourcing at almost every phase of the supply chain value stream. Developing strategic global supply chain outsourcing relationships with contract manufacturing partners can afford the pharmaceutical industry the opportunity to focus on core competencies, have access to specialized expertise, and enhance cost-saving benefits that can contribute to customer and shareholder values.

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Pharmaceutical global supply chain outsourcing drivers Pharmaceutical outsourcing trends and drivers include time to market, cost advantage, risk management, and strategic focus (PricewaterhouseCoopers LLP, 2006). The premier factors driving growth of pharmaceutical global outsourcing trend include competitive global marketplace, enhancing greater productivity flexibility, attaining a global manufacturing presence, expanding capacity, enhancing product quality achieved through costs reduction and better focus on core competencies, curtailing investments in capital assets, and improved asset utilization. Global supply chains outsourcing enables pharmaceutical firms to take advantage of global relative advantages, as well as increase product variety. The increasingly global nature of the pharmaceutical/biotech industry endorses outsourcing, as most companies tend to exploit the market by gaining competitive advantage. Pharmaceutical firms have recognized that possessing the entire skill range required within an industry is not feasible. As flexibility has become critically vital within the industry, firms are realizing that concentrating on core competencies is an efficient and effective way to create optimum value. Indeed the expansion in the pharmaceutical contract service industry in recent years has contributed to a significant boost in the number of services and functions available for outsourcing to contract manufacturing and R&D firms. In the recent years, the pharmaceutical firms have aggressively been reassessing their financial position and worst engaged in mergers and acquisition because of the mounting cost pressures and the need to survive. The critical factors driving the pharmaceutical industry to seek global outsourcing are the search for efficiencies in the drug development cycle, extending a company’s capacity, consolidation of the pharmaceutical industry, access to specific therapeutic expertise and globalization of the market within USA, Europe and Asia (Srivastava, 2002), and exploit new individualized drugs. Advantages/Disadvantages pharmaceutical global supply chain outsourcing Advantages and disadvantages associated with pharmaceutical global supply chain outsourcing to CROs (Piachaud, 2002) are reported in Table 2. Further, Datamonitor (2006) suggested that the advantages linked to pharmaceutical global supply chain outsourcing are 1) opportunity to drive productivity and efficiencies across a variety of business functions, 2) boosting long-term R&D productivity, 3) financial benefits, 4) shortening drug discovery stage, 5) access to additional drug discovery expertise and technologies, 6) flexibility, and 7) focusing free-up resources for core competencies, while the disadvantages include 1) level of returns on compounds generated through outsourcing agreements tend to be lower than in-house, 2) reduced opportunity to develop internal expertise, 3) loss of control and issue of confidentiality of proprietary information. Report by: Enyinda, I. Chris of Alabama A & M University ; Charles Briggs of North Dakota State University & Khalid Bachkar of North Dakota State University

IPI Outsourcing & Innovation Supplement 2017/2018


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IPI Outsourcing & Innovation Supplement 2017/2018

IPI - Outsourcing & Innovations Supplement 2017/2018  
IPI - Outsourcing & Innovations Supplement 2017/2018  
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