“Alone we can do so little, together we can do so much” is a Helen Keller quote which captures the spirit of CASSS-organized conferences like WCBP, the regional CMC strategy forums, and technology specific meetings. These venues offer platforms to exchange knowledge and align perspectives on manufacturing and controlling of biopharmaceuticals. Over the past 25 years, a variety of accomplishments have been achieved thanks to an attention to science and risk management. In this session CMC experts from regulatory agencies and industry will reflect in a familiar atmosphere on their personal highlights and learnings, including:
• WCBP was born out of the separation sciences community. What applications of separation sciences do you judge to be most consequential to the understanding and regulation of biologicals today?
• Strategies to assess comparability after manufacturing process changes and regulatory expectations were a recurring element at WCBP meetings. What have been the most positive outcomes from discussion in this area? With the benefit of hindsight: What should have been done differently?
• The heroic efforts by industry and regulators to deliver successful vaccines and therapies for COVID would not have been possible without the groundwork of exchange and mutual understanding. What lessons have been learned from earlier discussions regarding breakthrough therapies? What further improvements might be made in the development and regulation of biologicals to facilitate efficient delivery of medicines and vaccines?
• It feels like the former assumption ‘The process defines the product’ was reversed over the years with implementation of ‘quality by design’ elements into biologicals development and control. What have been the positive, and negative outcomes from the implementation of this approach?
Session Facilitator: IP Wassim Nashabeh, Genentech, a Member of the Roche Group
Session Participants: IP Andrew Chang, Novo Nordisk Inc. V Steven Kozlowski, CDER, FDA IP Philip Krause, Retired; CBER, FDA V Anthony Ridgway, Retired; Health Canada V Ilona Reischl, AGES MEA IP Nadine Ritter, Global Biotech Experts, LLC