Biologics have resulted in new treatments that have helped advance medical care. While they have been hugely successful, they are also more difficult and costly to manufacture than small molecule drugs. As the promise of biotherapeutics for the treatment of cancer, diabetes, and other diseases grows, so does the complexity of manufacturing and the reinforcement of regulatory constraints. Companies willing to develop a biomanufacturing capability need to anticipate the technological and regulatory constraints in order to assure safety, efficacy, quality and performance of new lifesaving biologics. This session will discuss these challenges and how ACCINOV, a biomanufacturing platform based in France, is supporting companies by offering a dedicated environment for addressing regulatory issues and promoting the development of enabling technologies for stronger quality control and new production process development.

Learning Objectives:

• Assess the technological and regulatory complexities of manufacturing biologicals
• E-Coli platform: a cooperative project launched with the French Technological Research Institute
• Discuss novel technologies that can help overcome quality control challenges in biomanufacturing

Ability Level: All

Session ID: 1947