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CDMO Services

Quality Control

Offers a wide range of testing services to support GCTP/GMP manufacturing

Multiple quality control laboratories dedicated to specific discipline in order to support the in-house testing of customer’s cell and gene therapy products.

  • Compendia microbiological assays to meet Japanese, U.S, and European Pharmacopeia
  • Environment, personnel, and utility monitoring to ensure these areas meet regulatory requirements and expectations
  • Bacterial identification to the species level to support facility monitoring investigations
  • Cell based assays to support identity, potency, and purity assays
  • Analytical testing for raw material qualification and acceptance
  • Stability testing and study design to meet ICH compliant stability studies for product integrity and stability over time and various storage conditions ranging from liquid nitrogen (< -135 °C) to ambient conditions
  • GCTP : Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
  • GMP : Good Manufacturing Practice
  • CDMO : Contract Development and Manufacturing Organization