Novart builds first Asian CAR-T production facility to fill Kymriah production gaps!

There are pharmaceutical giants that are interested in cell therapy and gene therapy, a booming field, but a common challenge is troubling them: How to make these therapies quickly and cheaply? On Friday, Novarma said Japanese regulators had approved the commercial production of Kymriah at its Kobe-based Biomedical Research and Innovation centre, making it the first factory in Asia to market the next generation of cancer therapy.
in December, Novart opened another plant in Stein, Switzerland, and hired 450 new employees to produce the therapy, which will increase Kymriah's global production footprint.
also commercially produces Kymriah at its plants in Morris Plains, New Jersey, and Les Ullis, France, as well as Kymriah at its contract manufacturing facility at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany.
also plans to produce the treatment at Cell Therapies in Australia and China-based Cellular Biomedicine Group, according to a statement.
, the FDA also approved the expansion of the Novarmaurice Plains plant.
spokesman for Novar3 did not say how much capacity the Kobe plant would add to Kymriah's global footprint, but noted that it had more than tripled Kymriah's capacity in the past year.
the logistics challenges have hampered Kymriah's spread, Novart hopes to rapidly expand the treatment's geographic footprint.
December, Novaral opened a bottleneck by launching its Stein plant in Switzerland, which specializes in tailor-made cell therapies for patients in Europe.
, European patients needed two transatlantic flights to the company's only plant in Morris Plains, USA.
Kymriah was originally approved by the FDA in August 2017 to treat relapsed or refractic (R/R) B-cell acute lymphoblastic leukemia (ALL), making it the first CAR-T approved in the United States to treat any allergic disorder.
was subsequently approved by Kymriah in May 2018 for the treatment of B-cell lymphoma and is seeking a third treatment for fable lymphoma, which the company expects to submit in 2021.
opened in December, the Stein plant in Switzerland employed 185 people, many of whom worked at Novarma's "traditional chemical and pharmaceutical manufacturing" plants in Basel, Schweizerhalle and Stein.
plans to increase its workforce to 450 over three years and invest $90.6 million.
as approvals for new cell and gene therapies are expected to increase over the next few years, drugmakers are paying huge investments to overcome the expected manufacturing crisis.
yescarta, the cell therapy from Gilead's Kite, is the second CAR-T therapy approved by the FDA and has been expanding rapidly, including the long-awaited 117,000-square-foot plant at SEGRO's Amsterdam Airport Industrial Zone (SPAA) in June.
the latest facility is Gilead's "next step" in upgrading Yescarta's global manufacturing industry, which will be able to meet the needs of 4,000 patients a year, according to Chuck Calderaro, Kite's head of global technology operations.
source: Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility