Process validation is the most critical step after developing and finalizing the design space prior to clinical/commercial product manufacturing.
Process Validation is a lifecycle activity that collects and evaluates process data and knowledge from early process development through to commercial manufacture and on-going supply chain maintenance. It is a vital component for the successful commercialization of biological products.
Activities include:
- Validation Master Plan development
- Commercial scale process performance qualification batches to evaluate process consistency
- Scale down studies to examine chromatography resin and membrane reuse
- Viral inactivation and removal studies
- Bulk filter validation
- Extractables and leachables evaluation
- Genetic characterization and stability assessmentsOn-going full scale process verification and statistical process control