Advances in the validation of chromatographic processes : Improvements in process validation approaches have resulted in better process understanding

Over the past five years many advances have enabled better process understanding and a more cost-effective approach to process validation. The application of risk management tools, design of experiments (DoE) for process characterization, equipment that is scalable, and sophisticated analytical tools all have contributed to a more rational approach to downstream process validation. Additionally, platform technologies based on experience with classes of products, such as monoclonal antibodies and DNA plasmids, have simplified validation approaches. Validation is no longer just 3 to 5 consecutive conformance batches; rather, it is a process that begins in development and uses a life-cycle approach for continuous improvements.