A Guide to Optimizing Analytical Strategies Throughout the Biologics Development Life Cycle
Summary: This executive summary provides an overview of the current landscape and common pitfalls associated with the development of a biologic. Access insight from one of Catalent’s drug product development experts and learn how to tailor your analytical programs to best fit your study needs at all project stages including implications for CMC regulatory submissions.
Key insights:
- An introduction to the analytical testing landscape
- Catalent’s stepwise approach for analytical testing
- Common challenges and mitigation strategies for analytical testing for biologics’ programs