Analytical Development

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.

  • 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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