From selection of a cell line to release of the first clinical batch, product and process developers make decisions that have timeline, financial, and regulatory consequences. As contract manufacturing becomes the norm rather than the exception in our industry, it is important that a Sponsor and CMO make the best use of each other’s expertise for maximum benefit to product and patients. In this presentation, Dr. George Koch, Chief Scientific Officer for Contract Manufacturing and Director of Project Management with Fujifilm Diosynth Biotechnologies, provides insight into:
• Selecting a CMO
• Process and Method Development
• The First Tox Lots
• The First Clinical Lots
View this on-demand educational webcast to learn more about manufacturing best practices for preclinical activities.