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Producing Value Boehringer Ingelheim BioXcellence™ Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence™ Producing Value Boehringer Ingelheim BioXcellence™ 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 www.bioxcellence.com 3 Boehringer Ingelheim BioXcellence™ Our Mission: Producing Value 4 BioXcellence | Producing Value 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 more than 200,000 liters with flexible scales in the field of biotechnology, having been in between 400 and 12,000 liters. For products the industry for more than 35 years and in derived from microbial fermentation technol- contract manufacturing since 1995. During ogy more than 12,000 liters of commercial that time we have helped our customers to capacity with flexible scales from 200 liters to bring 19 molecules to the market. This has 4,500 liters are installed at our site in Vienna, earned us a reputation as one of the most Austria. experienced and reliable contract manu- facturing organizations (CMO) in the world. With more than 2,300 employees in bio- Boehringer Ingelheim Contract Manufacturing pharma development, quality and manu- has now evolved into Boehringer Ingelheim facturing Boehringer Ingelheim BioXcellence BioXcellence™ - your dedicated contract is your sustainable, committed contract manufacturer. development and manufacturing partner - producing value for you. Boehringer Ingelheim BioXcellence™ provides the entire production technology chain from DNA to fill and finish at our facilities in Biber- ach (Germany), Vienna (Austria) and Fremont (USA). We have a total commercial capacity of www.bioxcellence.com 5 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 Producing Value Our Biopharmaceuticals Production Sites Fremont, California, USA Biberach, Germany Vienna, Austria Experience Boehringer Ingelheim Quality Product Company Year Type Berofor® Boehringer Ingelheim 1983 Microbial At Boehringer Ingelheim BioXcellence™ we are Actilyse® Boehringer Ingelheim 1987 Mammalian Imukin® Boehringer Ingelheim 1990 Microbial well aware of the responsibility that comes Betaferon® Bayer 1995 Microbial with contract manufacturing – producing Verluma® Boehringer Ingelheim 1996 Mammalian reliable biopharmaceutical products for Enbrel® (US) Pfizer/Amgen 1998 Mammalian patients. Synagis® (US) Medimmune/Abbott 1998 Mammalian Synagis® (EU) Medimmune/Abbott 1999 Mammalian To this end, our production plants operate Beromun® Boehringer Ingelheim 1999 Microbial under cGMP and are approved as such. We Enbrel® (EU) Pfizer/Amgen 2000 Mammalian not only meet the highest level of compliance, Metalyse® Boehringer Ingelheim 2001 Mammalian but strive to exceed it, both through regular Campath® (US) Genzyme 2001 Mammalian internal audits and by asking external consul- Actimmune® (US) Intermune 2001 Microbial tants to give us an outside perspective. Last Synagis® (JP) Medimmune/Abbott 2002 Mammalian and most important, we value the input of Bexxar® (US) GSK/Corixa 2003 Mammalian our partners through their regular audits and Erbitux® (EU) Merck Serono 2004 Mammalian leverage these opportunities to continually Enbrel® (JP) Pfizer/Amgen 2004 Mammalian improve our processes. Preotact® Nycomed 2007 Microbial Erbitux® (JP) Merck Serono 2008 Mammalian Infergen® 3 Rivers 2009 Microbial The track record of our multi-product facili- Forteo® Eli Lilly 2010 Microbial ties include inspections by the Food and Prolia® (US/EU) Amgen/GSK 2010 Mammalian Drug Administration (FDA), the European Revasc®/Iprivasc® Canyon 2010 Microbial Medicines European Medicines Agency (EMA), Vectibix® (US) Amgen 2011 Mammalian Health Canada, MHLW, SFDA, and many other Betaseron® (US) Bayer 2011 Microbial authorities. www.bioxcellence.com 7 Get your Product to Market faster Boehringer Ingelheim BioXcellence™ 8 BioXcellence | Producing Value Producing Value Finding the optimal strategy together Tailored Transfer It is our ambition to maintain our position as one of the We provide established and proven transfer procedures to industry’s most trusted manufacturing partners. enable seamless, reliable second source- and legacy product As your partner, we offer you the opportunity to leverage supply. Our well experienced transfer teams develop together our expertise and process excellence at any stage of the with you a tailored transfer scenario. In a ‘one team ap- development and production process. Our transparent proach’ all necessary work packages for facility adaptation, and modular approach guarantees you complete project production transfer and installation of product specific ana- flexibility while maintaining full control over the process. lytical quality methods are identified and executed focused Together with you, we will be happy to identify the project on product- and process comparability. design that is most suitable for your strategic objectives and then implement it — while ensuring maximum Pharmaceutical Development efficiency, safety, quality and cost effectiveness. Boehringer Ingelheim BioXcellence™ offers pharmaceutical development of biopharmaceuticals, applying state-of- Lean-to-Clinic the-art technologies for sophisticated pre-formulation, Reaching investigational new drug application (IND) formulation and pharmaceutical process development. is a critical milestone for most companies. Boehringer The dosage form portfolio ranges from solutions, highly Ingelheim BioXcellence™ has established a ‘Lean-to-Clinic’ concentrated liquid formulations, suspensions, lyophilized program for monoclonal antibodies which consists of or spray-dried powders to inhalable presentations streamlined work packages based on platform technologies combined with state-of-the-art proprietary application and standardized processes. It significantly speeds up systems. cell line development, Phase I process development and preclinical and clinical supplies. Fill and Finish We provide the entire drug product manufacturing chain Smart-to-Launch comprising filling, lyophilization, visual inspection, Our Smart-to-Launch approach ensures fast track project labeling and packaging. Within our global manufacturing transfer to commercial scale. We transfer your project network we can supply different dosage forms such as into our facilities and deliver clinical phase III material, liquid or lyophilized preparations in vials and technically commercial product or early second source supply focused more complex dosage forms such as prefilled syringes and on extremely short timelines. dual-chamber cartridges. www.bioxcellence.com 9 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 Producing Value Boehringer Ingelheim BioXcellence™ welcomes your enquiries, questions and feedback. www.bioxcellence.com [email protected] Contact Americas Dr. Axel Schleyer Vice President BD & KAM Americas [email protected] Contact Europe Dr. Monika Henninger-Erber Vice President BD & KAM Europe [email protected] Contact Asia/Pacific Hans-Peter Grau Vice President BD & KAM Asia/Pacific [email protected] Copyright © Boehringer Ingelheim Pharma GmbH & Co. KG, September 2012. 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 www.bioxcellence.com.
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