Process Validation: A Critical Step in a Biopharmaceutical Product’s Lifecycle

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards commercial launch, process validation ensures that the manufacturing process is sufficiently robust to provide the expected and consistent quality throughout the product’s lifecycle. In this interview, Pharmaceutical Technology spoke with Claudia Berdugo-Davis, Ph.D., director of process development at Catalent Biologics about the role strategy plays in process validation and the challenges faced.

Learn more about: 

• What is process validation and why it is important to apply process validation though the entire product life cycle? 
• What are the obstacles the field is facing with process validation and what are the solutions? 
• How are the process development models designed and validated?