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