Workshop III: Back to the Future: Leveraging Existing Playbooks to Create Robust Manufacturing Processes for Novel Modalities

In recent years there has been a significant effort to expand the types of modalities used to target various disease pathways or for use as a vaccine. Examples of these modalities include fusion proteins, bi- and tri-specifics, multivalent scaffold proteins, peptide mAb fusions, mAb mimetics, as well as mRNA and anti-sense oligonucleotides. In addition to differences in the manufacturing process, compared to traditional mAbs, many of these modalities also rely on complex formulations creating various challenges for routine manufacturing. Even though this requires exploring new approaches for development, manufacturing, and scale-up, the industry can build on the vast amount of experience gathered with the manufacturing of traditional biologics. The purpose of this session is to discuss approaches which have been used by companies to accommodate new modalities as well as the challenges encountered compared to traditional biologics. Specifically, the session will cover:

-    Efficient approaches to screening and assessing manufacturability

-    How to overcome productivity and scale-up challenges to ensure materials meet high-quality standards and demand while controlling cost of goods 

-    Comparability strategies to assess the impact of changes of quality attributes to safety, efficacy, PK, or immunogenicity 

-    Flexible process and facility designs to accommodate the larger diversity of modalities




Session Speakers:

09:05 - 09:30
Manufacturing Challenges for Bi-specific Antibodies from an FDA Standpoint
Wen Jin Wu, CDER, FDA
09:30 - 09:55
Leveraging a Novel Flexible Facility Concept to Provide Solutions to Current and Future Manufacturing Challenges
Charles Christy, Lonza
09:55 - 10:20 
Development and Manufacturing of an Engineered IL-2, Reprogrammed for Anti-Tumor Therapy, Using a Semi-Synthetic Organism
Christopher Means, Synthorx, a Sanofi Company