Vaccine Research Center: Process Development and Manufacturing for Clinical Trials - Presentation 8C

Explore vaccine research and development processes in this 28-minute lecture from the NIH Clinical and Translational Research Summer Course. Delve into the intricacies of vaccine production, including cell line development, upstream and downstream process development, and formulation. Learn about manufacturing and biophysical risk assessment, analytical development, and the importance of producing safe, consistent-quality vaccines for human clinical trials. Gain insights into the unique resources available at the NIH, potential career opportunities, and connect with researchers and program administrators. For further information about the course, contact the coordinator at [email protected].

Intro
Vaccine Process Development
Manufacturing and Biophysical Risk Assessment (MBRA)
Vaccine Production Process Overview
Cell Line Development
Cell Culture (Upstream) Process Development
Downstream Process Development
Developing a Column Chromatography Process Step
Formulation Development
Analytical Development
One (or 6) little Amino Acids won't make a difference....
At the end, a Safe Vaccine of Consistent Quality is Produced for Human Clinical Trials