Process Validation

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 assessments
On-going full scale process verification and statistical process control.

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