Meet our 2010 Plenary Speakers

Opening Up BioProduction 2010’s Key Themes with essential insights

Implementation of QbD for biologics - an update on case study and pilot initiatives and current industry practices
Over the last few years, the implementation path for application of Quality by Design to biologic pharmaceutical development has become increasingly clearer, due in large part to collaborative industry initiatives and the encouragement of international health authorities. This talk will overview the role of the A-Mab case study, well as the FDA’s biotech pilot program and other Health Authority interactions, in driving implementation of QbD in the biologics arena.
Dr Lynne Krummen, Senior. Director, Pharma Technical Regulatory, Genentech, Inc., USA

Application of RNAi to transform bioprocessing

RNA interference is being applied in bioprocessing to optimize and improve the production of biologics. Using this approach, multiple key pathways can be potently targeted individually or in combination. Such treatments can be transiently applied to suspension cell cultures grown at scale in bioprocessors, and can result in significant improvements in cell performance impacting both product yield and quality.
Dr Anthony Rossomando, Senior Director, Biotherapeutics/Bioprocessing, Alnylam Biotherapeutics, USA 

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