Boehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence

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1 Boehringer Ingelheim BioXcellence Producing Value Global Contract Manufacturing Excellence

2 Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence

3 Producing Value Boehringer Ingelheim BioXcellence is a leading contract manufacturer with more than 35 years of experience and 19 biopharmaceutical products brought to market. We provide tailor-made solutions where you need us, when you need us Our transparent, modular approach -regardless of your project s stage, scope or scales- makes outsourcing easy Our experience, reliability and flexibility help you to better focus on your strategic priorities As a family-owned business, we pride ourselves on stability and committed long-term relationships 3

4 Boehringer Ingelheim BioXcellence Our Mission: Producing Value 4 BioXcellence Producing Value

5 Producing Value We provide smart manufacturing solutions to the industry, empowering our customers to successfully navigate the challenges of the biopharmaceutical market. Boehringer Ingelheim has a long history in the field of biotechnology, having been in the industry for more than 35 years and in contract manufacturing since During that time we have helped our customers to bring 19 molecules to the market. This has earned us a reputation as one of the most experienced and reliable contract manufacturing organizations (CMO) in the world. Boehringer Ingelheim Contract Manufacturing has now evolved into Boehringer Ingelheim BioXcellence - your dedicated contract manufacturer. Boehringer Ingelheim BioXcellence provides the entire production technology chain from DNA to fill and finish at our facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA). We have a total commercial capacity of more than 200,000 liters with flexible scales between 400 and 12,000 liters. For products derived from microbial fermentation technology more than 12,000 liters of commercial capacity with flexible scales from 200 liters to 4,500 liters are installed at our site in Vienna, Austria. With more than 2,300 employees in biopharma development, quality and manufacturing Boehringer Ingelheim BioXcellence is your sustainable, committed contract development and manufacturing partner - producing value for you. 5

6 Boehringer Ingelheim BioXcellence Where you need us, when you need us All of the elements required for outsourcing biopharmaceutical development and manufacture, from high expression systems to fill and finish, including patient convenient application systems, can be found within the service offering of Boehringer Ingelheim BioXcellence. We offer our customers an integrated, seamless approach to reliable and efficient outsourcing. This includes process development, cell culture technologies, microbial technologies, upstream technologies, downstream technologies, tech transfer and scale up, process validation, pharmaceutical development, analytical labs, CMC documentation support, formulation, fill and finish, packaging, shipping validation and much more. Whether you are looking for contract development and manufacturing of individual work packages only or for a partner for the entire product life cycle we are looking forward to talking to you. Where you need us when you need us. 6 BioXcellence Producing Value

7 Producing Value Our Biopharmaceuticals Production Sites Fremont, California, USA Biberach, Germany Vienna, Austria Experience Boehringer Ingelheim Quality At Boehringer Ingelheim BioXcellence we are well aware of the responsibility that comes with contract manufacturing producing reliable biopharmaceutical products for patients. To this end, our production plants operate under cgmp and are approved as such. We not only meet the highest level of compliance, but strive to exceed it, both through regular internal audits and by asking external consultants to give us an outside perspective. Last and most important, we value the input of our partners through their regular audits and leverage these opportunities to continually improve our processes. The track record of our multi-product facilities include inspections by the Food and Drug Administration (FDA), the European Medicines European Medicines Agency (EMA), Health Canada, MHLW, SFDA, and many other authorities. Product Company Year Type Berofor Boehringer Ingelheim 1983 Microbial Actilyse Boehringer Ingelheim 1987 Mammalian Imukin Boehringer Ingelheim 1990 Microbial Betaferon Bayer 1995 Microbial Verluma Boehringer Ingelheim 1996 Mammalian Enbrel (US) Pfizer/Amgen 1998 Mammalian Synagis (US) Medimmune/Abbott 1998 Mammalian Synagis (EU) Medimmune/Abbott 1999 Mammalian Beromun Boehringer Ingelheim 1999 Microbial Enbrel (EU) Pfizer/Amgen 2000 Mammalian Metalyse Boehringer Ingelheim 2001 Mammalian Campath (US) Genzyme 2001 Mammalian Actimmune (US) Intermune 2001 Microbial Synagis (JP) Medimmune/Abbott 2002 Mammalian Bexxar (US) GSK/Corixa 2003 Mammalian Erbitux (EU) Merck Serono 2004 Mammalian Enbrel (JP) Pfizer/Amgen 2004 Mammalian Preotact Nycomed 2007 Microbial Erbitux (JP) Merck Serono 2008 Mammalian Infergen 3 Rivers 2009 Microbial Forteo Eli Lilly 2010 Microbial Prolia (US/EU) Amgen/GSK 2010 Mammalian Revasc /Iprivasc Canyon 2010 Microbial Vectibix (US) Amgen 2011 Mammalian Betaseron (US) Bayer 2011 Microbial 7

8 Get your Product to Market faster Boehringer Ingelheim BioXcellence 8 BioXcellence Producing Value

9 Producing Value Finding the optimal strategy together It is our ambition to maintain our position as one of the industry s most trusted manufacturing partners. As your partner, we offer you the opportunity to leverage our expertise and process excellence at any stage of the development and production process. Our transparent and modular approach guarantees you complete project flexibility while maintaining full control over the process. Together with you, we will be happy to identify the project design that is most suitable for your strategic objectives and then implement it while ensuring maximum efficiency, safety, quality and cost effectiveness. Lean-to-Clinic Reaching investigational new drug application (IND) is a critical milestone for most companies. Boehringer Ingelheim BioXcellence has established a Lean-to-Clinic program for monoclonal antibodies which consists of streamlined work packages based on platform technologies and standardized processes. It significantly speeds up cell line development, Phase I process development and preclinical and clinical supplies. Smart-to-Launch Our Smart-to-Launch approach ensures fast track project transfer to commercial scale. We transfer your project into our facilities and deliver clinical phase III material, commercial product or early second source supply focused on extremely short timelines. Tailored Transfer We provide established and proven transfer procedures to enable seamless, reliable second source- and legacy product supply. Our well experienced transfer teams develop together with you a tailored transfer scenario. In a one team approach all necessary work packages for facility adaptation, production transfer and installation of product specific analytical quality methods are identified and executed focused on product- and process comparability. Pharmaceutical Development Boehringer Ingelheim BioXcellence offers pharmaceutical development of biopharmaceuticals, applying state-ofthe-art technologies for sophisticated pre-formulation, formulation and pharmaceutical process development. The dosage form portfolio ranges from solutions, highly concentrated liquid formulations, suspensions, lyophilized or spray-dried powders to inhalable presentations combined with state-of-the-art proprietary application systems. Fill and Finish We provide the entire drug product manufacturing chain comprising filling, lyophilization, visual inspection, labeling and packaging. Within our global manufacturing network we can supply different dosage forms such as liquid or lyophilized preparations in vials and technically more complex dosage forms such as prefilled syringes and dual-chamber cartridges. 9

10 Your Product. Our Passion. Local Business Development and Key Account Management globally Boehringer Ingelheim BioXcellence has established Business Development and Key Account Management (BD & KAM) teams in the major markets (Americas, Europe and Asia-Pacific). Our local expert representatives are the first point of contact for our customers. They take care of our customers and their projects from early information exchange to the end of the project, and ensure smooth transfer to our project management at our facilities in Austria, Germany or USA. 10 BioXcellence Producing Value

11 Producing Value Boehringer Ingelheim BioXcellence welcomes your enquiries, questions and feedback. Contact Americas Dr. Axel Schleyer Vice President BD & KAM Americas Contact Europe Dr. Monika Henninger-Erber Vice President BD & KAM Europe Contact Asia/Pacific Hans-Peter Grau Vice President BD & KAM Asia/Pacific Copyright Boehringer Ingelheim Pharma GmbH & Co. KG, September All rights reserved. No part of this brochure may be reproduced or transmitted in any form or by any means, electronic or photocopy, without permission in writing from Boehringer Ingelheim Pharma GmbH & Co. KG. September 2012

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