IBC Life Sciences

IBC's 6th Early Development symposium, Preclinical Scale Bioprocessing, offered a forum for discussion of the methods and approaches used from lab to pilot scale to produce materials used by R&D, animal studies and CMC development. Delegates gained valuable perspectives on the planning, systems, analytical methods and technologies used to improve the speed and flexibility of production at this critical stage of development.

The conference faculty provided insights from both small and large organizations and from programs in both novel protein therapeutics and monoclonal antibodies. A combination of case studies, facilitated discussion sessions and overview presentations, allowed attendees to return to their workplaces with strategies that could be applied right away to improve process development and streamline coordination with other functional areas in the organization. Highlights of the 2009 program included:

• Genzyme presented a case study outlining its criteria and strategy for selecting an interim reference standard, and how this standard established a baseline for product quality profiles
• Genentech demonstrated a scalable and flexible data management system that supports cross-site knowledge of multiple products and provides an end-to-end view of the full development production process
• Biolex detailed its experience developing an economical upstream process for an expression platform based on single use components and how it was implemented as a GMP system
• Dyax shared its strategy for evaluating manufacturability considerations at the lead selection stage to ensure products with high quality drug-like properties
• Ambrx discussed the benefits of using a strategy for early analytics that balances speed, scarce resources and the quality needed to support scientific and business activities in the development process

Stay tuned for details on the date and location for the fall, 2010 Preclinical Scale Bioprocessing meeting.