Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility

kymriah
Novartis added 450 workers at a cell and gene therapy site in Switzerland back in December. (Novartis)

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. 

RELATED: Novartis' new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah

Novartis has looked to rapidly ramp up its geographic footprint for Kymriah as logistical challenges have hamstrung the pricey and difficult-to-make therapy's rollout. 

In December, Novartis opened the Stein site specifically to manufacture tailored cell therapies for European patients, opening a bottleneck that previously required two transatlantic flights to the drugmaker's sole facility in Morris Plains. 

Kymriah initially received the FDA's go-ahead to treat lymphoblastic leukemia in August 2017, making it the first CAR-T approved on U.S. shores for any indication. Novartis followed that up with a Kymriah approval in B-cell lymphoma in May 2018 and is chasing a third indication in follicular lymphoma, where it may file for approval next year. 

At time of opening in December, the Stein location employed 185 employees, many of whom previously worked at Novartis' "traditional chemical and pharmaceutical manufacturing" sites in Basel, Schweizerhalle and Stein. Novartis planned to hike that workforce up to 450 workers and make a $90.6 million investment over three years. 

RELATED: With cell and gene therapy boom coming, experts at Novartis, Kite trumpet need for capacity

With approvals for novel cell and gene therapies expected to tick up in the coming years, drugmakers are making huge down payments to overcome a projected manufacturing crunch. 

Gilead Sciences, which produces Yescarta, the second CAR-T therapy approved in the U.S., has also been expanding rapidly, including opening a long-awaited 117,000-square-foot plant at SEGRO Park Amsterdam Airport in June. 

The newest facility is the "next step" in Gilead's global manufacturing ramp-up for Yescarta, according to Chuck Calderaro,  global head of technical operations for Gilead's Kite unit, as the site will be able to churn out enough of the pricey therapy for 4,000 patients each year.