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Since the pandemic began, biopharmaceutical companies have been partnering with government and regulatory agencies to expedite a new generation of therapeutic and vaccine approaches. These partnerships have shed a new light on novel CMC approaches that have accelerated manufacturing and testing. In this session, panelists from around the world including representatives from government agencies and industry will share their experiences with how accelerated CMC approaches enabled rapid progression through development and how these experiences might be applied to future pandemics.
Both the EMA and FDA recognize the vital importance of the Higher Order Structure (HOS) of a protein. It is specifically called out in their guidances and it is their expectation that the latest technology be applied to understand it…