Current Challenges During CMC Development and Delivery of Novel Modalities

19 September 2023 15:30 - 16:00

The expansion of biopharmaceuticals into so called “novel modalities” have encountered new challenges and opportunities during CMC development and clinical administration/drug delivery. This presentation will cover some of the pain points for novel modalities and highly potent (low dose) biotherapeutics, considerations for Drug Product design, formulation, manufacturing, and compatibility in-use studies, and case studies for early clinical studies

Cesar Calero, Senior Scientist Biologics Drug Product Development & Manufacturing, Sanofi