The recently Food and Drug Administration-approved cell therapy for leukemia relies on a specially developed cell therapy system (CTS) technology developed by laboratory equipment maker Thermo Fisher Scientific.
Last week, multinational pharmaceutical company Novartis received FDA approval for its CAR-T treatment marketed under the brand name Kymriah. The groundbreaking chimeric antigen receptor T cell (CAR-T) treatment uses a patient’s own immune cells to destroy aggressive blood cancer cells.
The therapy uses Thermo Fisher’s CTS Dynabeads technology, according to the equipment manufacturer. Dynabeads is part of the company’s 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.
CTS Dynabeads CD3/CD28 beads deliver a scalable platform that streamlines production while ensuring high reproducibility.
“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, according to Thermo Fisher.
Thermo Fisher’s collaboration with Novartis was originally announced in 2013. The collaboration has since 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.
Thermo Fisher’s proprietary magnetic bead platform is already enabling research, development and commercial manufacturing of other cancer-treating CAR-T cell therapies around the world, the company said.
The benefits of using Dynabeads include:
Low background—little to no non-specific binding and no pre-clearing required for high-purity protein yields.
- Highly reproducible—uniform beads ensure the most consistent results.
- Highly sensitive—most-cited method for sensitive applications, such as ChIP and IP, of low- abundance proteins.
- Fast and easy—<40 min protocol with no centrifugation or pre-clearing steps.
- Antibody savings—all binding occurs on the smooth outer surface of the beads, which conserves precious antibodies and supports a cost-efficient solution per sample.
- Flexible—products for IP, Co-IP, pull-down, and ChIP assays; ideal for manual and automated protocols.
- Automation of IP protocol—The Thermo Scientific KingFisher platform supports immunoprecipitation automation.
Magnetic beads have become the gold standard for immunoprecipitation (IP) and pull-down assays because they offer a faster, easier, and more efficient way of pulling down proteins of interest than traditional Sepharose agarose or other agarose-based resins, according to Thermo Fisher.