From manufacturing to testing and storage, Charles River Biopharmaceutical Services (BPS) provides vaccine manufacturers and researchers with complete support in the development of clinical vaccines based on client-supplied specifications. Our dedication to quality ensures compliance with all applicable international regulatory standards.
BPS is part of the Charles River vaccine program, which utilizes global corporate expertise to provide vaccine manufacturers with enormous flexibility and convenience in the development of their vaccines. BPS provides cGMP manufacturing and testing of vaccines for clinical trials and potency assays (lot release) of commercial product. In addition, we have many years of experience manufacturing vaccines from both cell culture and SPF eggs (supplied by Charles River Avian Vaccine Services).
Our Preclinical Services group provides toxicology, in vivo safety, tumorgenicity, oncongenicity, general safety and pharmacokinetic studies in a variety of species. Clients can have confidence that the vaccine program at Charles River will meet and exceed their vaccine development requirements and expectations.
cGMP Manufacturing Capabilities
- Virus seed and cell banking
- Vaccine manufacturing via cell culture and SPF eggs
- Vaccines for clinical trials (manufacturing scale - up to 7,500 vials per batch)
- Pilot scale virus manufacturing
- cGMP storage capability
cGMP Testing Capabilities
- Viral seed and cell bank characterization
- In vivo potency assays (lot release of commercial products)
- Biosafety and release testing
- Cell subtrate/vaccine testing and characterization
- Fill and finish
To check which of our BPS facilities offer vaccine manufacturing and testing services and get local facility contact information, click here. For more information, please contact us at askcharlesriver@crl.com.