Anti-thymocyte Globulin (Rabbit)

Sanofi has announced a €40 million investment in its Lyon Gerland bioproduction site, enhancing its capabilities in immunology-focused drug production. The investment supports the production of Thymoglobulin, used in transplantation, and localizes the manufacturing of TZIELD, a type 1 diabetes treatment, to France. Of the total investment, €25 million will fund the development of a second-generation polyclonal antibody for transplant patients, increasing production capacity and improving environmental sustainability. An additional €15 million will be allocated to producing monoclonal antibodies for type 1 diabetes treatment, previously manufactured outside the EU. Modernization efforts at the Lyon site began in mid-2024, with the first industrial batches of the updated polyclonal antibody expected in 2025 and commercial availability in 2027. Production of the existing treatment continues alongside these upgrades. Similarly, production of the immunomodulatory type 1 diabetes treatment will begin in late 2025, targeting market availability in 2027.

Sanofi says its Lyon Gerland site is the sole manufacturer of Thymoglobulin, producing some 1.6 million vials of the treatment for approximately 70,000 patients each year. With several high-profile manufacturing outlays already in the books in Europe this year, Sanofi is returning to the bloc in a bid to boost production for a long-approved transplant treatment and a relatively new Type 1 diabetes drug.Late last week, Sanofi unveiled a 40 million euro ($42.3 million) investment at its Lyon Gerland biomanufacturing site in France.The cash infusion will help cement the site’s immunology pedigree by bolstering local production of the company’s polyclonal antibody Thymoglobulin for kidney transplant rejection as well as provide expected future capacity needs for Type 1 diabetes drug Tzield, Sanofi said in a French language press release.Sanofi got its hands on Tzield, which was first approved by the FDA to delay the progression of Type 1 diabetes, in November 2022 after it completed its $2.9 billion buyout of Provention Bio in early 2023. Of the total investment at Lyon Gerland, 25 million euros are being channeled toward manufacturing and development of a second-generation version of Thymoglobulin, Sanofi explained in its release. The remaining 15 million euro tranche will be used to internalize and localize production of the CD3-directed monoclonal antibody Tzield, the company said.As it stands, Sanofi says its Lyon Gerland site is the sole manufacturer of Thymoglobulin, producing some 1.6 million vials of the treatment for approximately 70,000 patients each year.Following “modernization work” that kicked off this summer, Sanofi has developed a new manufacturing process that it expects to increase production capacity for the immunosuppressant, make supply more reliable and curb the environmental impact of production, according to the release.The first industrial batches using the new process will be rolled out in 2025 with the expectation that the new version of Thymoglobulin will become commercially available in 2027.Apart from Thymoglobulin, Sanofi also plans to develop a new bioproduction zone for Tzield at the Lyon Gerland site. The Type 1 diabetes drug was previously manufactured outside the European Union by a separate company, Sanofi pointed out in its release.Back in January 2023—just a few months before Sanofi’s Provention buyout closed—Provention tapped AGC Biologics for commercial manufacturing of Tzield. Sanofi did not immediately respond to Fierce Pharma’s request for comment on whether that supply pact is still in place.Development of the new bioproduction zone for Tzield will begin in early 2025, with the first product batches expected by the end of next year for marketing in 2027, Sanofi said last week.Sanofi’s latest manufacturing foray in Europe follows several other large investments this year.In May, for instance, Sanofi said it would spend 1 billion euros (then around $1.1 billion) to build a new facility at Vitry-sur-Seine in France to double capacity for monoclonal antibodies, creating 350 new jobs along the way. At the same time, the company said it had earmarked 100 million euros ($108 million) for its Le Trait facility in Normandy, where the French pharma manufactures the anti-inflammatory blockbuster Dupixent.That same month, Sanofi also set aside 10 million euros ($10.8 million) to beef up Tzield production in Lyon Gerland. More recently, Sanofi in August blueprinted a new 1.3 billion euro insulin factory at the company’s campus in Frankfurt Höchst, Germany.With plans to complete the project by 2029, Sanofi has said the plant will eventually house “several hundred” new employees on top of the German campus's existing workforce of more than 4,000.