Accelerating Process Development: New Approaches to Biopharmaceutical Design
Today’s new mantra, “better, faster, safer (and cheaper)” lies at the core of the evolving drug development paradigm emerging from the FDA. Numerous cutting-edge innovations are being designed to reduce process inefficiency and cost while creating a new series of risk-based methodologies and analytical tools. This is creating a scenario in which smaller capitalized drugs, vaccines, and personalized medicines are an attractive business model for biopharmaceutical companies. So what effect do these changing paradigms have on today’s bio/pharmaceutical process design and development teams? How is increased process knowledge changing approaches to process development and manufacturing?
At INTERPHEX 2010 moderator S. Anne Montgomery (Editor in Chief, BioProcess International) will lead panel of industry experts in a discussion of modern process design activities, with an emphasis on case studies.
Click here to hear audio previews of this roundtable discussion.
Manufacturing Roundtable: April 21, 2010 from 12:30 p.m. to 2:00 p.m.
Market Globally, Manufacture Locally? Geographic Trends and Strategies in Biomanufacturing
In 2008, the 10 largest multinational biomanufacturers controlled ~80% of world capacity, concentrated in North America and Europe. With the recession, mergers, technological advances, and the entry of China and India, there may even be excess capacity worldwide. However, factors such as: emerging countries’ growing demand, supply chain and biosecurity concerns, and new, disruptive technologies (e.g., single-use, automation, cell-free systems), are driving interest in smaller, more distributed production. Today, key geographic decisions confront bio-developers, such as: building at home vs outsourcing overseas, managing heterogeneous regulations and IP laws, and protecting products from supply chain risks. How will innovation, more skilled and mobile labor and emerging country markets and manufacturers affect biopharma manufacturing strategy decisions?
At INTERPHEX 2010 a panel of global experts will forecast geographic trends and discuss strategies to turn geographic constraints into global opportunities for safer, cheaper, faster and better biological products.
Click here to hear audio previews of this roundtable discussion.
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