Charles River Laboratories International Inc. has launched its new CliniPrime suite of Good Manufacturing Practice (GMP)-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.
 
“The CliniPrime Fresh Leukopak will help accelerate clients’ work in the development of advanced therapeutics for clinical trials of potentially life-saving modalities of treatment,” said Birgit Girshick, executive vice president and chief operating officer, Charles River.
 
With the CliniPrime portfolio Charles River now offers two options for GMP-compliant cellular starting material. CliniPrime products 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 (RUO) cellular products that include fresh leukopaks and other cellular products.