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CART


Creative Biolabs now provides cGMP process for the manufacture of genetically CAR-T cells qualified for therapy. Based on our robust and scalable CAR-T cells manufacturing platform for product commercialization, Creative Biolabs can provide one-stop CAR-T cells manufacture services to meet our customers’ needs and keep adherence to cGMP and regulatory guidelines. These include enclosed system operations, robust process improvement, work flows simplification, process automation implementation, product testing and tracking, etc..

CAR T cells are novel products that have unique characteristics that may impact product and clinical aspects of regulating these products. There are challenges with almost every aspect of the product development including CMC, patient monitoring, and trial design from eligibility to long term follow up. CAR T cell science is a moving target and maintaining regulatory flexibility as knowledge improves is key to effective drug development.

Manufacture of CAR-T cells for therapy

Figure. Product manufacture and testing

CAR-T treatment: current and future

• To date less than 1,000 patients treated globally
• High value products & clinical results have lead to a movement from chemical drugs to biotherapeutics to ATMPs
• Huge increase in pharmaceutical interest
• Regulations have adapted to industry requirements (e.g.):
  - ATMP regulations
  - Multi product manufacturing
  - Risk management principles (ICH Q9)

Manufacture of CAR-T cells for therapy

Reference:
Towards a commercial process for the manufacture of genetically modified T cells for therapy. Kaiser e tal. Cancer Gene Therapy (2015) 22, 72–78

To discuss your CART demands or to request a proposal, please contact us by