Charles River Laboratories International, Inc. announced the launch of their new CliniPrimeTM suite of Good Manufacturing Practice compliant cellular starting materials. CliniPrime products provide rapid access to starting materials for cell, and gene-modified cell therapies with a standardized production process for high-quality GMP-compliant products. All CliniPrime products meet the essential regulatory guidelines for clinical trial development and the commercial manufacturing of advanced therapies.

The first CliniPrime product, the CliniPrime Fresh Leukopak, fulfills the industry need for ready access to cGMP-enabled, enriched leukocyte cellular starting materials. CliniPrime leverages Charles River's established production processes to provide advanced therapy programs a high-quality product offering to support both clinical trial development and commercialization, while reducing client resource investment and risk. With the CliniPrimeportfolio Charles River now offers two options for GMP-compliant cellular starting material.

CliniPrimeproducts provide a standardized production process while GMPrime™products enable clients to customize the production process of cellular starting material to meet specific needs for their program. Those two options for GMP-compliant starting material are also complemented by the HemaPrime portfolio of research use only cellular products that include fresh leukopaks and other cellular products. Charles River has been a trusted provider of cell products and services for leading developers of cutting-edge cell therapies and basic research for more than 40 years through its acquisitions of HemaCare and Cellero (formerly Key Biologics and Astarte Biologics), now officially integrated as Charles River Cell Solutions.

Charles River's donor centers, known as HemaCare Donor Centers, are available coast-to-coast with locations in Northridge, CA, Bothell, WA, Memphis, TN and Lowell, MA. HemaCare Donor Centers are FDA-registered, AABB-certified, and state-licensed. They work with local donors to contribute critical material to support medical breakthroughs.

HemaCare Donor Centers process a variety of blood products including whole blood, bone marrow, white blood cells (apheresis) and mobilized white blood cells. These cells are collected and used worldwide in scientific research, drug development, and manufacturing for cell therapies. All donations are anonymous, and donors receive compensation for their time.

Combined with Charles River's integrated, early-stage portfolio of research models, discovery, safety assessment and CDMO cell and gene therapy manufacturing services, Charles River Cell Solutions provides cellular products and services, from research use to GMP-compliant products and consultative guidance, including cell processing and isolation services, creating clear pathways for client cell therapy or basic research objectives.