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Increasing sophistication of bioprocess development discussed at BPI Europe

Following on the heels of the annual BIO convention in the US, the BioProcess International Europe conference held in Vienna May 18-20 reinforced our optimism regarding the strength and continued growth of our industry. Attendance at the meeting was good with over 200 paid delegates participating in five concurrent tracks covering advances in upstream and downstream processing, scale-up strategies, formulation development, and analytical methods.

Key topics addressed at the conference included the rapid production of biopharmaceuticals of consistently high quality, the importance of developing effective and efficient manufacturing processes, quality by design, new and advanced analytical methods for the characterization of biopharmaceutical products, and advances in formulation development to ensure the development of safe, efficacious, and scalable formulations.

The meeting kicked-off with two excellent plenary lectures covering the diverse topics of vaccine production and biosimilar development. Russell Thirsk, Global Head of Influenza Cell Culture for Novartis Vaccines gave an excellent summary of Novartis’s response to last year’s H1N1 influenza outbreak: rapidly developing and scaling up production of an effective vaccine in cell culture. Dr. Thirsk’s presentation made it abundantly clear that the future of vaccine production will be cell culture-based rather than the traditional egg-based production methodology used in the past. In addition to Novartis Vaccines, several other companies are developing cell culture-based influenza vaccines, including Baxter, Protein Sciences, and Novavax.

Jan Visser, Head of Technical Development for Sandoz, Slovenia presented an excellent overview of biosimilar development both by Sandoz and others. Sandoz was one of the first companies to initiate development of biosimilar products and currently has three biosimilar products on the market in Europe and is actively developing biosimilars for the US market. As we commented in an earlier post, the recent health care legislation in the US, which includes a framework for approval of biosimilars in the US, has spurred intense interest in this area with increasing focus on the ability of biosimilar companies to rapidly develop products that are suitably comparable to the original innovator product to ensure the safety and efficacy of these products. Dr. Visser presented Sandoz’s strategy of applying advanced analytical methods and the concepts of QbD to build comparability into the product, ensuring the same quality, safety, and efficacy of the originator product.

In a “visionary talk” on the future of biomanufacturing, BioProcess Technology Consultants President Howard Levine tied BPTC’s updated analysis of biomanufacturing supply and demand with recent advances in cell culture titers, overall process yields, and the growing availability of more flexible single use technologies for both upstream and downstream applications to convincingly argue that the biotech industry has sufficient manufacturing capacity to meet market needs for the foreseeable future. Dr. Levine further argued that improvements in manufacturing technologies and the increasing development of targeted therapeutics for smaller niche markets imply that the biotech “factory of the future” will be significantly different than today’s “six-pack facilities” with multiple bioreactors of 10,000 L or more. Rather, tomorrow’s biotech manufacturing facility will be based on fewer and small volume bioreactors (possibly disposable bioreactors) with increased floor space devoted to downstream processing to handle the higher bioreactor output. This paradigm shift in biomanufacturing needs and facility design was supported by presentations from other speakers throughout the conference.