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

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.