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European Biopharmaceutical Review
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| Crawford Brown and Roger Lias of Eden Biodesign, Inc argue that in order for outsourced manufacturing strategies to work for vaccine development as they do for monoclonal antibodies, manufacturing development needs to account for the unique properties of vaccines
Interest in vaccines has never been greater, as shown by substantial high-profile private and public investment in the sector. For example, the market for vaccines for children and adolescents, is estimated to grow from $4.3 billion in 2006 to $16 billion by 2016 (1). Product development service providers, including contract manufacturing organisations (CMOs), can bridge vaccine translational research, enabling sponsors to rapidly develop and access new vaccines during early-stage clinical trials.
Many companies developing vaccines, unlike biotech companies developing monoclonal antibody products, need to make considerable capital investment in establishing their own manufacturing facilities, often at a time when capital is required to support clinical development. Table 1 shows a selection of top-tier biotechs that are developing vaccines and have established internal manufacturing capability.
This trend reflects, in part, the unique process and analytical challenges faced in developing each new vaccine, when compared to the platform approach that is more readily adopted for monoclonal antibody products (MABs). This article focuses on process design issues for the development of vaccines, comparing current commercial, technical and regulatory trends with the issues faced by companies developing highly characterised monoclonal antibodies. RAPIDLY EXPANDING MARKET OPPORTUNITIES FOR BIOTECHS DEVELOPING VACCINES
The adage that ‘prevention is better than cure’ has been the basis for substantial interest in vaccines over the past few years from:
- Governments
- Pharmaceutical companies
- Not-for-profit organisations
For governments struggling with rising healthcare costs, vaccines represent a cost-effective investment: for preventing illness; for government personnel rapidly mobilised for overseas operations; for use against pandemics, such as influenza; and more recently for preventing cancers caused by viral infections |
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Dr Crawford Brown, Chief Executive Officer, co-founded Eden Biodesign, Inc in 2000 from Celltech-Medeva where he was Director of Product Development and was responsible for developing and manufacturing the biotech product pipeline. Among his achievements Crawford managed and led a successful pan-European submission for a complex recombinant vaccine which included an EMEA sponsored pre-approval inspection. Crawford has held senior technical management positions in both biotech and pharmaceutical companies and has been actively engaged in commercial biopharmaceutical development for over 20 years. As well as leading the company, he retains a major role in Eden Biodesign’s consultancy services.
Dr Roger Lias is President of Eden Biodesign, Inc and Group Commercial Director. Roger’s responsibilities include identifying and establishing strategic business partnerships and expanding Eden Biodesign’s offer to the large North American biopharmaceutical sector. Prior to joining Eden, Roger held the position of Vice President, Sales and Business Development at Cytovance Biologics. At KBI BioPharma, a start-up contract biomanufacturing company, he played an active role in securing funding, building revenues and was responsible for identifying and establishing strategic business partnerships and new business relationships. Prior to this, he was Vice President, Business Development, at Diosynth where he had global responsibility and headed North American sales and marketing for Lonza Biologics. |
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10th-Anniversary Event RFID Journal LIVE! 2012
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RFID Journal LIVE! 2012, our tenth annual conference and exhibition, is the only event where you can learn how to use RFID technologies to improve your pharmaceutical and medical packaging business, from real-world case studies across all applications, including asset tracking, logistics and transportation, supply chain management, warehouse and inventory management, security and more. Learn from a customized program featuring more than 50 end-user case studies and 8 industry-specific and how-to conference tracks.
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