The tech behind the first FDA-approved CAR-T cell therapy
The manufacturing process for Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy, Kymriah, requires the reprogramming of a patient’s T cells.
T cells, or T lymphocytes, are a subtype of white blood cell and play a key role in cell-mediated immunity.
Thermo Fisher’s CTS Dynabeads CD3/CD28 enables the ex vivo isolation, activation, and expansion of these cells, which are then genetically engineering to fight the cancer cells within an individual patient.
“The technology combines the use of anti-CD3 and anti-CD28 antibodies on the Dynabeads to provide both the primary and co-stimulatory signals that are required for activation and expansion of T cells,” Deb Barbara, senior director, therapeutic licensing and commercial supply at Thermo Fisher told Outsourcing-Pharma.com.
To ensure the technology met the quality standards set by Novartis, Thermo Fisher established a 21,000 sq. ft. aseptic manufacturing facility in Vilnius, Lithuania, which is dedicated to the GMP manufacturing of Dynabeads CD3/CD28 for use by cell therapy commercial developers, Barbara explained.
“We transferred and scaled our manufacturing process from the Thermo Fisher-staffed Oslo-based CMO to our new aseptic Vilnius based facility and produced three validation batches,” she said.
“We had beautiful synchronization of our operations, quality and regulatory teams, encompassing hundreds of team members, to not just deliver on our promises to Novartis but also to other cell therapy developers.”
Moving forward, Barbara explained Thermo Fisher will continue to be a partner in the supply of a critical raw material required for the manufacture of Kymriah.
The companies have been collaborating since late 2012 since which time the relationship has evolved from exclusive to non-exclusive – enabling other CAR-T cell therapy developers to adopt Thermo Fisher’s platform.
According to the company, the proprietary magnetic bead platform is already enabling research, development, and commercial manufacturing of other CAR-T cell therapies across the globe.
