A Strategy To Standardize Process Characterization & Late Phase Development – Cell Culture Optimization
Source: Catalent

Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial manufacturing, understanding the operational, regulatory and quality connections is critical for successful filing and launch.
This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step. This approach will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.
VIEW THE CASE STUDY!
Log In
Signing up provides unlimited access to:
Free Sign Up

Signing up provides unlimited access to:
- Trend and Leadership Articles
- Case Studies
- Extensive Product Database
- Premium Content
HELLO. PLEASE LOG IN.
X
Not yet a member of Pharmaceutical Online? Register today.
ACCOUNT SIGN UP
X
Please fill in your account details
ACCOUNT SIGN UP
Catalent
This website uses cookies to ensure you get the best experience on our website. Learn more