Our Quality Control (QC) team works closely with Manufacturing, Quality Assurance, Analytical Development and MSAT teams to satisfy our customers, meet regulatory requirements, and ensure the success of the GMP manufacturing operation. We are committed to continuously provide support for the production of high-quality biopharmaceutical products through robust programs of sample management, stability, in-process and lot release testing and data trending.
Bioanalytical Testing Capabilities
Our QC scientists provide expertise based on extensive experience in GMP, using validated cutting-edge equipment and bioanalytical methods. The following are examples of some analytical test methods that our QC team is capable of:
Stability Program Capabilities
A dedicated controlled area, with validated and monitored stability chambers, enables the collection of GMP Drug Product/Drug Substance stability data. Physical and kinetic stability profiles are generated using real-time storage conditions and accelerated conditions of temperature and/or light.
Environmental and Clean Room and Utilities Monitoring
QC ensures that controlled environments are maintained for the manufacturing of high-quality products, by routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.). All analyses are performed under strict GMP requirements. Environmental Monitoring includes testing for Viable / Non-viable particulates, Settle Plates, and Contact Plates. Clean Utilities Monitoring includes testing for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
The QC laboratories are composed of separate functional areas supporting raw material, analytical and biochemistry, microbiology, real-time qPCR, cell culture, and stability testing.
• Sample receipt
• Microbiology area includes cleanrooms (Grade D) for sterility testing within an isolator.
• PCR suite with separate rooms for preparation of reagents, extraction, and amplification.
• Controlled access room for stability testing under real-time and accelerated conditions: climatic and photostability chambers, 2-8°C, < ‒20°C, < ‒40°C, < ‒70°C
• Controlled access room for cell bank storage.
• 600m² laboratories with supporting special gases, storage, cold room, and washing room.