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Theravectys has been granted authorization by the French National Agency for Medicines and Health Product Safety to produce lentiviral vectors for Phase I to Phase III testing at its manufacturing plant.
Theravectys, a biotechnology company specializing in clinical development of therapeutic vaccines and immunotherapies, has been granted authorization by the French National Agency for Medicines and Health Product Safety to produce lentiviral vectors for Phase I to Phase III testing at its manufacturing plant. The facility will also be used to manipulate human cells in the context of chimeric antigen receptors (CARs) and t-cell receptor (TCR)-based cell therapies in the future.
The authorization further strengthens Theravectys’ position in the field of lentiviral vectors and in supplying immunotherapeutic treatments that help stimulate and modulate the immune system from the initial vector design to the final release of clinical batches. Theravectys plans to produce cGMP lentiviral vectors for its first Phase I and Phase II clinical trials in oncology (adult T leukemia/lymphoma induced by HTLV-1) as well as for its differentiated CAR-T cell-based immunotherapy programs.
Amel Hadri, head of quality assurance, said in a press release that receiving this pharmaceutical manufacturing establishment status marks a major achievement for Theravectys. The company will be able to control manufacturing costs and timelines, and will allow the company to better leverage the production processes for both research and clinical development material requirements.
The manufacturing facility, which consists of several production suites, fully complies with GMP and ISO standards. It includes upstream and downstream process rooms, an aseptic filling suite, and a logistic zone for GMP storage. The plant has the capacity to handle up to 24 active batches a year.