Process Validation: A Critical Step In A Biopharmaceutical Product's Lifecycle

Source: Catalent

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to market. As the program approaches commercial launch, process validation ensures that the manufacturing process is sufficiently robust to provide consistent product quality throughout the product’s lifecycle. Claudia Berdugo-Davis, Ph.D., director of process development at Catalent Biologics, discusses common strategies and challenges for process validation.

Learn more about the challenges the field faces for process validation and the importance of applying it throughout the entire product lifecycle.

access the Q&A!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Bioprocess Online? Subscribe today.

Subscribe to Bioprocess Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Bioprocess Online