Developing your molecules to initiate Phase I clinical trials
The CU Anschutz Gates Biomanufacturing Facility is here to help!
Presented by Matt Seefeldt
Executive Director, Charles C. Gates Biomanufacturing Facility
Initiating human Phase I clinical trials requires developing a scalable and compliant Good Manufacturing Process (GMP). We’ll review the basis for process design, a summary of FDA regulatory requirements, and the workplan required for generating process data to support an Investigational New Drug (IND) application. We’ll highlight the mission and capabilities of the Gates Biomanufacturing Facility to translate therapies on campus.