Challenges and Innovative Approaches to Improving the Efficiencies of Process Development and Tech Transfer

Over the last 35 years, the biopharmaceutical industry has undergone significant expansions both in terms of scale and the frequent need to support multiple sites. However, competitive and cost pressures have resulted in tighter budgets and timelines for development, tech transfer, and commercialization of new products. We will present some novel approaches to organizing and integrating process development (PD) activities that we feel will be required to maintain competitiveness in the years ahead including (1) integration of upstream and downstream development, (2) extension of a platform approach in manufacturing into development, (3) integrating an approach to criticality assessment with streamlining and automating process development activities, and (4) development of an overarching data and process recipe warehousing strategy to support development and registrational filings.