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Released December 11, 2019 | GALWAY, IRELAND
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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Novartis International AG (NYSE:NVS) (Basel, Switzerland) has inaugurated a new $90 million pharmaceutical plant in Stein, Switzerland, that will focus on gene and cell therapies.
The plant, which will employ up to 450 people in the coming years, could also help ease the manufacturing bottleneck for its CAR-T cancer therapy Kymriah, which is still awaiting approval in Europe. A regulatory decision is due in early 2020 and, if favourable, commercial production can start immediately at the new facility. The plant building also hosts the production of difficult-to-manufacture solid dosage forms such as tablets and capsules. In September 2019, the first clinical production of a cell and gene therapy batch was successfully completed, Novartis said. Industrial Info is tracking 40 Novartis global projects worth $765 million in investment.
"Our site in Stein is vital for new launches of solid and liquid drugs," said Steffen Lang, global head of Novartis Technical Operations and member of the Novartis Executive Committee. "The construction of the new manufacturing facility is another investment in the production of breakthrough cell-based therapies that can potentially change the lives of patients."
Unlike conventional drug production, cell and gene therapy requires the manufacture of a personal dose for each patient. As a result, patients who have already undergone various therapies have a small amount of their own blood cells taken, which are then sent to Stein, explained Dorothea Ledergerber, project manager of the Stein plant for cell and gene therapies. "Here we enrich part of the white blood cells, the T cells, and genetically modify them so that they can recognize and fight the cancer cells in the patient's blood. The altered cells are then sent back to hospital and administered to the patient by infusion. We have the unique opportunity to offer patients for whom there have been no other therapeutic options a totally new perspective by using these novel CAR-T cell therapies."
Novartis has established the manufacturing process for Kymriah at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany, which currently supports the manufacture of Kymriah for clinical trials worldwide and post-approval manufacturing. The company already operates a cell and gene therapy manufacturing facility in Morris Plains, New Jersey, in the U.S.
In July, Industrial Info reported that Novartis had offloaded its sterile drug product fill and finish facility in Stein to Lonza Group (Basel, Switzerland). The site has two pharmaceutical manufacturing facilities for solid and sterile dosage forms which, at the time of the sale, Novartis said was being under-utilised. Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers. For additional information, see July 17, 2019, article - Novartis Sells Swiss Manufacturing Plant to Lonza.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
The plant, which will employ up to 450 people in the coming years, could also help ease the manufacturing bottleneck for its CAR-T cancer therapy Kymriah, which is still awaiting approval in Europe. A regulatory decision is due in early 2020 and, if favourable, commercial production can start immediately at the new facility. The plant building also hosts the production of difficult-to-manufacture solid dosage forms such as tablets and capsules. In September 2019, the first clinical production of a cell and gene therapy batch was successfully completed, Novartis said. Industrial Info is tracking 40 Novartis global projects worth $765 million in investment.
"Our site in Stein is vital for new launches of solid and liquid drugs," said Steffen Lang, global head of Novartis Technical Operations and member of the Novartis Executive Committee. "The construction of the new manufacturing facility is another investment in the production of breakthrough cell-based therapies that can potentially change the lives of patients."
Unlike conventional drug production, cell and gene therapy requires the manufacture of a personal dose for each patient. As a result, patients who have already undergone various therapies have a small amount of their own blood cells taken, which are then sent to Stein, explained Dorothea Ledergerber, project manager of the Stein plant for cell and gene therapies. "Here we enrich part of the white blood cells, the T cells, and genetically modify them so that they can recognize and fight the cancer cells in the patient's blood. The altered cells are then sent back to hospital and administered to the patient by infusion. We have the unique opportunity to offer patients for whom there have been no other therapeutic options a totally new perspective by using these novel CAR-T cell therapies."
Novartis has established the manufacturing process for Kymriah at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany, which currently supports the manufacture of Kymriah for clinical trials worldwide and post-approval manufacturing. The company already operates a cell and gene therapy manufacturing facility in Morris Plains, New Jersey, in the U.S.
In July, Industrial Info reported that Novartis had offloaded its sterile drug product fill and finish facility in Stein to Lonza Group (Basel, Switzerland). The site has two pharmaceutical manufacturing facilities for solid and sterile dosage forms which, at the time of the sale, Novartis said was being under-utilised. Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers. For additional information, see July 17, 2019, article - Novartis Sells Swiss Manufacturing Plant to Lonza.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
