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Process Validation

We offer a scalable process in order to help you prepare the clinical supply needed for commercial approval.

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CMC_capabilities_process_validation2For customers preparing for commercial approval and post-commercial approval, Process Validation is a critical and significant set of activities. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you with a targeted path through late-phase Process Validation. Our systems are based on the FDA’s Approved Guidance for Industry and ICH guidelines, using a risk-based lifecycle approach, and consist of three basic stages with supporting validation activities.

Stage I - Process Design

  • Identification of Critical Quality Attributes and Critical Process Parameters
  • Risk assessments
  • Process Control Strategy design
  • Bench-scale model qualification
  • Bench-scale process characterization / DOE studies

Stage 2 - Process Performance Qualification (PPQ)

  • At-scale PPQ campaign

Stage 3 - Continuous Process Validation Program

 

Stage 4 - Supporting Validation Activities

  • Mixing and Hold Time Validation
  • Extractables & Leachables
  • Impurity Clearance
  • API Freeze / Thaw Studies
  • Resin/Membrane Lifetime Validation
  • Virus Clearance Validation
  • Raw Material Qualification
  • Analytical Method Validation
  • Cell Line Qualification
  • Facility / Utility / Equipment Qualification
  • API Shipping Validation

Interested in learning more?

Contact our team