Charles River Biopharmaceutical Services (BPS) delivers client-focused solutions for the specific testing and manufacturing requirements of your biopharmaceutical. We provide tailored global testing and manufacturing services to help accelerate drug development from concept to product release.
Our BPS facilities in the U.S., U.K., Ireland, and Germany are part of a global scientific network, offering products and services that span the entire drug development process. Furthermore, BPS has agents in Australia, Japan, India, Korea, Singapore, and Taiwan to support our clients around the world.
As a global organization, BPS can provide you with more flexibility, experience, and expertise in multiple regulatory environments to accelerate the development of your biologic, enabling you to get your product to market faster.
BPS follows international regulatory guidelines for testing and clinical-scale manufacturing of biologics. The assays provided range from cell characterization and process-validation studies through to stability and product-release testing. Manufacturing services include cell banking, storage, fill and finish, and viral vaccine and antisera production.
Areas of expertise include:
- Cell banking and characterization
- Product characterization
- Process characterization (residual testing)
- Vaccines and cell therapy
- Viral clearance and TSE studies
- Lot release testing
- Stability testing
- In vivo biosafety and potency testing
- Discovery and development
- Polyclonal antisera production
We recently updated and expanded our Cologne, Germany-based viral clearance facility. This new state-of-the-art facility has the ability to handle up to five studies in parallel, which means more flexibility and improved timelines for clients. The new space also features an improved “zone” configuration, enabling a clearer, leaner workflow that further ensures contamination avoidance and Good Laboratory Practice (GLP) compliance.
We are also expanding our facility in Ballina, Ireland, to offer biosafety level (BSL)-2 in vivo challenge studies (bacterial and viral). The new self-contained, high-biosecurity shower-in unit includes 12 new animal rooms, allowing for increased capacity ideal for long-term vaccine and immunogenicity.
Charles River is committed to providing customers with exactly what they need to advance and expedite their research and the discovery, development and safe manufacture of new therapies for improved human health.