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Corporate Capabilities : Oct 1, 2011 (Vol. 31, No. 17)

Advertorial: Charles River

Helping Our Global Partners Accelerate Drug Discovery and Development for More than 60 Years

For more than 60 years, Charles River has been helping our global partners accelerate drug discovery and development by providing them with high-quality research models, preclinical services, process manufacturing support, and clinical trial support services. Our offerings span the entire drug development process, from discovery through market approval, providing our clients a seamless partnership throughout.

From the global standardization of our research models, to the high standards we set for our professional team and our state-of-the-art facilities and technologies, we can customize our products and services to meet clients’ specific research needs. With facilities around the world, Charles River is the ideal partner for moving a compound through development in a rational, cost-effective, and timely manner.

Markets Served

With more than 60 facilities in 16 countries, Charles River partners with leading pharmaceutical, biotechnology, government, and academic organizations around the world to provide products and services that span all stages of drug discovery and development. Our team of experts understands, and ultimately can help our customers comply with, complex and varying international scientific regulations.

Capabilities

Our offerings are continually expanding based on the changing needs of our customers, and our portfolio reaches from the discovery of new compounds and preclinical pharmacological and safety studies to clinical trials support. Charles River also provides biopharmaceutical testing and manufacturing services to help our partners efficiently navigate the complex approval process for safety and efficacy.

Biopharmaceutical Services

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.

Charles River

251 Ballardvale Street

Wilmington, MA 01887

Phone 877.CRIVER.1

Website www.criver.com

Date Founded 1947

Number of Employees ~7,500