Anti-thymocyte Globulin (Rabbit)

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Samsung Biologics has secured a number of manufacturing deals worth a total of $668 million with an unnamed European pharma client, the CDMO said Tuesday. The deals expire in 2031. Sanofi is investing €40 million ($42.1 million) to expand its bioproduction facility in Lyon, France, the company said Friday. In particular, €25 million ($26.3 million) will be used to make the antibody for Thymoglobulin and €15 million ($15.7 million) to make monoclonal antibodies for type 1 diabetes clinical-stage therapies. The UK regulatory agency MHRA has appointed University of Oxford professor Anthony Harnden as its new chair, according to a Tuesday release. Harnden replaces Stephen Lightfoot, who stepped down in April 2023. LIfT BioSciences has launched a new subsidiary called Eolaíocht Bhitheach LIfT Teoranta, which will operate from Galway, Ireland, the company said Monday. The subsidiary will collaborate with the University of Galway and medical tech manufacturer HookeBio to provide manufacturing and clinical services. Lonza has manufactured its first batch of drug products at its mammalian manufacturing facility in Portsmouth, NH, the company said Wednesday. Convergent Therapeutics has received its first shipment of the radioisotope actinium-225 from Cardinal Health to make its Phase 1/2 prostate cancer radiopharmaceutical, according to a Monday release. Meiji Seika Pharma is investing in the CDMO and mRNA vaccines company Arcalis to improve its supply of mRNA vaccines in Japan, according to a Thursday release. Arcalis will make the API for Meiji’s Covid-19 vaccine. No financial details were disclosed. India-based Unexo Life Sciences was handed an FDA warning letter published Tuesday. It outlined two key issues: failure to produce certain batch record data and dirty air conditioner vents above drug production areas. The White House published a report , dubbed Building a Vibrant Domestic Biomanufacturing Ecosystem, on Friday. It states that the US needs more infrastructure and technology to produce drugs domestically and outlines 11 actions that policymakers should consider to improve manufacturing.

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.