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TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.
TxCell SA announced on May 31, 2018 that Lonza Pharma & Biotech will manufacture TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.
TxCell finalized its CAR-Treg manufacturing process, and the transfer to Lonza started in February 2018, according to Lonza’s timeline. The companies report the transfer will be complete and clinical manufacturing is expected to start by the first quarter of 2019. Accordingly, TxCell now expects to file its first CTA with TX200 in the first part of 2019.
Lonza will manufacture clinical batches of TxCell’s HLA-A2 CAR-Treg cellular product from its production site in Geleen, The Netherlands, and the final product can be shipped in a frozen state to clinical sites in Europe and the United States. TxCell has demonstrated that the drug product could be both frozen and thawed with no change in cellular phenotype and function, the companies report in the press statement.
Source: Lonza Pharma & Biotech