French Agency for Medicines and Health Product Safety grants the company pharmaceutical manufacturing establishment status
Theravectys, a French clinical development biotechnology company, has been granted pharmaceutical manufacturing establishment status by the French National Agency for Medicines and Health Products Safety (ANSM).
The company's new plant in Paris will be used to produce lentiviral vectors for clinical development purposes, from Phase I to Phase III, and also to manipulate human cells in the context of chimeric antigen receptors (CARs) and T-cell receptor (TCR)-based cell therapies in the future.
With its new status, the company has become fully operational for supplying immunotherapeutic treatments that help stimulate and modulate the immune system from the initial vector design to the final release of clinical batches.
Amel Hadri, Head of Quality Assurance at Theravectys, says achieving this status is a major achievement for the company. 'We are proud of the team’s dedication to this project, which has allowed us to carry out the work and obtain the opening approval in just 12 months,' she said.
In the coming months, Theravectys plans to produce cGMP lentiviral vectors for its first Phase I and Phase II clinical trials in oncology (adult T leukaemia/lymphoma induced by HTLV-1) as well as for its differentiated CAR-T cell-based immunotherapy programmes.
The manufacturing facility complies with GMP and ISO standards. It consists of several independent production suites, including upstream and downstream process rooms, an aseptic filling suite, as well as a logistic zone that allows for GMP storage at various temperatures ranging from -80⁰C to +25⁰C. Additionally, the installation includes a quality control laboratory.
The plant will be able to handle up to 24 active batches annually. Human cells will be cultured in suspension in up to 1,000 litre bioreactors, using synthetic medium and disposable materials. Proprietary specific quality controls have also been developed, such as RCL, lentiviral vector quantification, residual DNA characterisation, fully internalised for better product qualification and more efficient batch releases.
'With the opening of our GMP manufacturing plant, the exclusive worldwide Intellectual Property (IP) licence from the Institut Pasteur, and the sponsor of the first-ever vaccination trial performed in a human with lentiviral vectors, Theravectys has now become the only company in the world to offer a fully-integrated and protected cutting-edge lentiviral vector technology platform,' said Renaud Vaillant, Chief Executive of Theravectys.