Breaking News, Trials & Filings

FDA Approves First CAR-T Immunotherapy

Uses Thermo Fisher’s CTS Dynabeads Technology

The FDA has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy, Kymriah (tisagenlecleucel, formerly CTL019), for the treatment of patients 25 years and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is the first FDA-approved CAR-T immunotherapy, which uses specifically developed Cell Therapy Systems (CTS) Dynabeads technology, part of Thermo Fisher’s Cell Therapy Systems (CTS) portfolio. The magnetic beads isolate, activate and expand T cells that have been genetically engineered to recognize and fight cancer cells in each individual patient.

The company’s collaboration with Novartis dating back to July 2013
has evolved from exclusive to non-exclusive providing the opportunity for other CAR-T cell therapy developers to adopt Thermo Fisher’s“ready for commercial drug manufacturing” T cell isolation, activation and expansion platform.

In cell therapy manufacturing, CTS Dynabeads CD3/CD28 beads deliver a scalable platform that help to streamline production with high reproducibility. Dynabeads products are for research use only or for the manufacturing of cell-, gene- or tissue-based products.

“Kymriah is an example of the rigor required to deliver viable cell therapies to physicians and their patients,” said Alan Sachs, chief scientific officer at Thermo Fisher Scientific. “We established a dedicated facility and a validated aseptic manufacturing process to ensure that our technology met the strict quality standards set by Novartis.”

The process for manufacturing Kymriah requires removing blood cells from the patient, isolating and reprogramming the T cells to recognize and attack cancer cells before infusing them back into the patient. CAR-T treatment embodies precision medicine because each patient’s therapy is manufactured expressly for them using their own cells.

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters