The course will focus on an Introduction to Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development and a secondary emphasis on how this differs from traditional “small molecule” pharmaceutical development. This entry level course will cover the following content:

• Overview of the biopharmaceutical development process and the role of QBD
• Early and late phase biopharmaceutical development: process, analytics, formulation, cGMP manufacturing
• High level comparison of CMC activities challenges between small and large molecules
• CMC Regulatory challenges

For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you the opportunity to learn from a live instructor, ask questions and participate in exercises.

https://ispe.org/training.