CU Innovations – Spark / Reach: Meet Scientific Leads from Catalent & Learn About Biologic Drug CMC Development to Ensure Successful Path to IND
Developing new biologics from early research is a complex endeavor. Failing to prepare for process development and manufacturing activities for clinical trials can cause delays and bears the risk of clinical trial failure. Clarity is needed around essential elements of the manufacturing process, quality control and assessment activities to guide the development and manufacturing work for early clinical trials.
Topics covered will include chemistry, manufacturing and control (CMC) overview of Biologic development from DNA sequence to clinical Drug Product, and special considerations for orphan/rare diseases.
Presented by: Wai Lam LING, Ph.D., Vice President, Scientific Advisory, Science & Technology for BioModalities; and Catalent Pharma Solutions