The blossoming field of cell and gene therapies has received a ton of interest from the world's largest drugmakers, but a common challenge plagues them all: How do you quickly and cheaply manufacture those therapies?
One strategy is going big. To boost manufacturing for cancer fighting CAR-T Kymriah, Novartis is going global, and it now has the green light to produce the therapy at its first Asian production site.
Japanese regulators approved the commercial manufacturing of Kymriah at the Foundation for Biomedical Research and Innovation at Kobe, making it the first site in Asia to produce the next-gen cancer-fighter for market, Novartis said Friday.
The Kobe site will add to Kymriah's global manufacturing footprint after Novartis planted another facility—and 450 new employees—in December to produce the therapy in Stein, Switzerland. Novartis also commercially manufactures Kymriah at its facilities in Morris Plains, New Jersey, and Les Ulis France, as well as at a contract manufacturing site at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany.
Novartis is also planning to make the therapy at Cell Therapies in Australia and Cellular Biomedicine Group in China, according to a release. The FDA recently approved an expansion at Novartis' Morris Plains site.
A Novartis spokeswoman didn't estimate how much capacity the Kobe site would add to Kymriah's footprint but noted the drugmaker has more than tripled its capacity over the past year.
