Novartis establishes the first car-t production facility in Asia
Previously, many pharmaceutical giants had great interest in the booming field of cell therapy and gene therapy, but they were plagued by a common challenge: how to manufacture these therapies quickly and cheaply?
Last year, Novartis said that Japanese regulators had approved its foundation for biomedical research and innovation in Kobe to commercialize the production of kymriah, making it the first market-oriented factory in Asia to produce this next-generation anti-cancer therapy.
Novartis has established another factory in Stein, Switzerland and recruited 450 new employees to produce this therapy. Kobe’s factory will increase kymriah’s global production footprint. Novartis also commercially produces kymriah in factories in Morris plain, New Jersey and Les Ulis, France, while commercially producing kymriah in the contract manufacturing plant of Fraunhofer Institute of cell therapy and immunology, Leipzig, Germany.
According to a statement, Novartis also plans to produce the therapy at cell therapies in Australia and cellular biomedicine group in China. Recently, the FDA also approved the expansion of Novartis Morris plain plant.
A Novartis spokesman did not say how much capacity the Kobe plant would add to kymriah’s global footprint, but he pointed out that the company had more than tripled kymriah’s capacity in the past year. As logistics challenges have hindered the promotion of kymriah, Novartis hopes to rapidly expand the geographical footprint of this therapy.
Novartis opened a bottleneck by starting the Stein plant in Switzerland to provide tailored cell therapy for European patients. Previously, European patients needed two transatlantic flights to the company’s only factory in Morris plain, USA.
Kymriah was originally approved by FDA in August 2017 for the treatment of recurrent or refractory (R / R) B-cell acute lymphoblastic leukemia (all), making it the first car-t approved in the United States for the treatment of any indication. Novartis subsequently obtained kymriah’s approval for the treatment of B-cell lymphoma in May 2018 and is seeking the third indication for the treatment of follicular lymphoma. The company is expected to submit an application in 2021.
At the time of opening, the Stein plant in Switzerland employed 185 employees, many of whom worked in Novartis’s “traditional chemical and pharmaceutical manufacturing” plants in Basel, schweizerhalle and Stein, Switzerland. Novartis plans to increase the number of employees to 450 within three years and invest US $90.6 million.
With the approval of new cell and gene therapies expected to gradually increase in the next few years, pharmaceutical manufacturers are paying huge investments to overcome the expected manufacturing crisis.
Yescarta, a cell therapy company from Geely De’s kite, is the second car-t therapy approved by FDA. The company has also been expanding rapidly, including the construction of a long-awaited 117000 square foot factory in segro Amsterdam Airport Industrial Zone (SPAA) in June 2020.
According to chuck calderaro, head of global technology operation of kite, this latest facility is Geely De’s “next step” in upgrading the global manufacturing industry of yescarta, because the plant will be able to meet the needs of 4000 patients for yescarta every year.