Chemistry, Manufacturing, and Controls (CMC) in Drug Development and Life Cycle Management

Summary

This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development. There are a multitude of complexities and points to consider when developing an asset, and product development is at the center of all development. Selection of the right development partner, who has experts in all aspects of CMC, is a critical first step as an asset is developed. The right development partner can ensure there is a consistent ‘end-to-end’ process and continuity in the development of your asset.

In this paper, you will learn about:

• CMC Considerations
• Why CMC is a critical component in drug development
• Why it is important to identify issues early
• Why CMOs are critical to success