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Laura Bush was editor in chief of BioPharm International.
Pushing frontiers in a maturing biotechnology industry.
The BIO convention is always a fun place to explore the future of the biopharmaceutical industry. Amid the talks on industry developments, the announcements of innovative therapies, and the energy of 20,000 networking professionals, it's easy to feel optimistic about the promise of biotech.
At this year's event, though, a different set of conversations, focused on manufacturing, is what got me excited. The editors of BioPharm International conducted two days of live podcast interviews at BIO to shed light on evolving bioprocessing trends. In those conversations, experts discussed manufacturing advances, best practices in areas like supply chain management and technology transfer, and the development of emerging technologies and emerging markets.
What struck me through all of these conversations was how the frontiers of biotech continue to move.
One recurring theme, for example, was the maturation of biotech manufacturing, particularly for highly platformed antibody production. This has led to a significant emphasis on efficiency, in sharp contrast to 10 years ago. "In the '90s, when the race was to bring products to market . . . you had a very difficult time justifying a project on cost-of-goods reduction," noted Peter Watler of JM Hyde Consulting. "That's no longer the case today."
A much-cited strategy for improving efficiency is making manufacturing plants more flexible. For new facilities, Watler points out, this means modular designs that incorporate a lot of disposable equipment. For older sites, as Mike Kowolenko of Wyeth explained, it means retrofitting to convert plants into modern, multipurpose facilities. This is an important advance, given that most biotech plants are used to manufacture products that are different from the products for which they were designed.
But just as antibody production is showing signs of maturity, other areas, like personalized medicine, are only emerging and present difficulties that don't arise with traditional drugs. For example, with small batches of product, it is difficult to follow the FDA's guidance on out-of-specification results, which suggests re-testing seven times. The lack of a potency test also makes ensuring efficacy very difficult. "It may conceptually take a different approach to product design, development, and clinical studies, for patient-specific drugs to be successful," said Stephan Krause of Favrille.
Other product types, like vaccines, are re-emerging and expanding. Roger Lias of Eden Biodesign notes that there is a "vast array" of vaccine candidates in development, making process development much more challenging. "There's really no standard platform for producing many of these novel vaccines," he said. "They all need different production processes."
Meanwhile, geographical frontiers are opening up. When it comes to quality, for example, be prepared for China to catch up, said Ian Sellick of Pall Corporation. "I think the perception, based on perhaps some outdated experience, is that GMP is not a great thing in China," he said. "But the reality is that the SFDA has a mandate to promote GMP culture in China." His words are backed up by experience; his company has been manufacturing equipment in China for more than 15 years.
By conducting these live podcast interviews, we are doing our own bit of exploring, pushing out to the frontiers of publishing. Everything new brings uncertainty, however. In this case, one concern is foremost for us: audience acceptance. Based on the number of people who listened during only the first few days, the response is excellent. But we would like to know more. Is a podcast interview a useful way for you to keep up with industry developments? We encourage you to listen to a few of these short interviews (at biopharminternational.findpharma.com/BIOPodcasts) and to let us know what you think.