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European Biopharmaceutical Review

Seize the Market

Modern biopharmaceuticals such as monoclonal antibodies (mAbs) and fusion proteins play an important role in the treatment of severe diseases, including cancer and autoimmune disorders. This market is expected to increase with a compound annual growth rate (CAGR) of 9.4% from 2015 to 2020, based on more than 280 biopharmaceuticals on the market and hundreds in clinical studies (1). In 2016, the FDA approved seven mAb drugs, three recombinant blood factors and three biosimilars (2-4). The number of approvals of new biopharmaceuticals by the EMA was in the same range (5).

The well-filled drug development pipeline of biopharmaceutical companies is the base for this notable progress, but the advancement of such complex products requires considerable effort and special expertise as well as state-of-the-art capabilities. Therefore, many firms outsource part of their activities to contract development and manufacturing organisations (CDMOs). The corresponding biopharma contract manufacturing market is predicted to grow with a CAGR of 13.4% from 2015 to 2020 (1).

Under the current market conditions, mid-size CDMOs are particularly important. They often focus on special segments like mammalian- or microbial-based development of recombinant proteins and typically provide bioreactor scales smaller than 10,000L. Most have many years of experience and offer a broad range of services and capabilities along with proprietary innovative technologies and well-established manufacturing platforms. A lot of them have expanded their capabilities in the past few years and established new stainless steel or single-use bioreactor capacities, allowing them to act with a high degree of flexibility in manufacturing for various clinical phases and for market supply.

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Dr Stefan R Schmidt, MBA, currently serves as Senior Vice President at Rentschler Biotechnologie, Germany, and is responsible for the process science and manufacturing of biopharmaceuticals to current Good Manufacturing Practice standards. He previously held the position of Chief Scientific Officer at ERA Biotech, directing the company’s R&D efforts focusing on fusion peptides. Prior to that, Stefan worked at AstraZeneca where he led the unit of Protein Sciences as Associate Director. In the past 10 years, he has been intensively involved with fusion proteins, publishing the first comprehensive book on the topic in 2013.

Dr Birgit Schwab is Marketing Manager at Rentschler Biotechnologie, responsible for the market research including market, competitive and client analysis as well as conducting surveys. She studied Chemistry in Dresden, Germany, and completed her PhD in the area of Analytical and Theoretical Chemistry. Since 2004, Birgit has been working at Rentschler in Sales and Marketing and has been involved in different fields such as proposal management and sales controlling. 
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Dr Stefan R Schmidt
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Dr Birgit Schwab
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