Product/Service

Manufacturing For Pre-clinical Safety, Toxicology And Efficacy Testing

Janet Rothberg at hood

CCRM can develop pre-clinical processes and analytics suitable for animal toxicology and efficacy studies. We have on-site expertise in a wide range of cell drug products, formats and formulations. CCRM has experience in developing processes for animal studies from cell source to final product using cutting-edge laboratory equipment for different cell products.

  • Batches for GLP pre-clinical / animal studies produced in our ISO 9001 laboratories
  • Process and analytical data captured in Electronic Laboratory Notebooks
  • Process and analytical development for animal studies and future clinical manufacturing
  • Analytical release of product for GLP animal studies
  • Regulatory support and direction
  • Links to pre-clinical testing houses, including bioanalytical testing for  immunogenicity

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