Validations and Comparative studies to Manufacture CAR-T Cells in GMP Conditions
Manufacturing CAR-T cells in GMP conditions is a complex and highly regulated process that requires careful attention to detail, quality control, and compliance with the most rigorous standards. By following these guidelines, CAR-T therapies can provide promising outcomes for cancer patients with a strong focus on safety, precision, and efficacy.
Pioneering Cell Therapy with Precision and Safety
CAR-T Cell Production
- Our process begins with a sample of a patient’s own (autologous) or a donor’s (allogeneic) T cells, typically through leukapheresis or apheresis (out of our process).
- The collected cells are transported to a GMP facility, where they are the starting point for CAR-T production.
- T cells are isolated from the collected leukapheresis product and activated, often using antibodies or other activation methods.
- This activation primes the T cells for genetic modification with the CAR.
- A viral vector is used to introduce the CAR gene into the T cells.
- The CAR gene encodes a receptor that recognizes a specific antigen on the patient’s cancer cells.
- Once a sufficient number of CAR-T cells have been produced, they are harvested and formulated for infusion into the patient (out or process).
Rigorous quality control testing is conducted at every step, including:
- Identity and purity of the CAR-T cell product.
- Sterility to ensure the absence of contamination.
- Assessment of CAR expression levels.
- Potency and functional testing to confirm the CAR-T cells’ ability to target cancer cells.
- Testing for endotoxins, mycoplasma, and other potential contaminants.
Documentation and Regulatory Compliance:
Comprehensive records are maintained throughout the manufacturing process, including batch records, quality control data, and deviations.
Strict adherence to regulatory requirements is paramount, as CAR-T therapies are subject to regulatory oversight by health authorities.
CAR-T
