Path to Improved Biopharmaceutical Drug Development Productivity

The biotech industry has been and continues to be innovation driven since its inception in the ‘70s.  The pharmaceutical industry, including biopharmaceuticals, has been facing increasing challenges to continue to improve productivity from R&D through commercialization even with the technological advances made to date.  Changes to regulatory guidance, advances in bio-manufacturing technology and a greater understanding and control of critical quality attributes presents opportunities to reshape and improve biopharmaceutical R&D productivity however.  This talk will discuss phase appropriate cGMP guidance, single use technology, and control of critical quality attributes through control of process equipment and the role they can play in advancing biopharmaceutical development.