Process Validation: A Critical Step in a Biopharmaceutical Product’s Lifecycle
Summary: Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. 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. Pharmaceutical Technology spoke with Claudia Berdugo-Davis, Ph.D., director of process development at Catalent Biologics, about common strategies and challenges for process validation.