THERAVECTYS Plant Gains Mfg. Status from ANSM

THERAVECTYS’ manufacturing plant has obtained the status of a pharmaceutical manufacturing establishment, granted by the French National Agency for Medicines and Health Products Safety (ANSM). The new facility will produce lentiviral vectors for clinical development from Phase I through Phase III, and will also be used to manipulate human cells for chimeric antigen receptors (CARs) and t-cell receptor (TCR)-based cell therapies.
 
The company is now fully operational to supply comprehensive immunotherapeutic treatments from the initial vector design to the final release of clinical batches.
 
The production site is designed in compliance with GMP and ISO standards, and 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. It also includes a quality control lab.
 
The plant is capable of handling as many as 24 active batches annually. Human cells will be cultured in suspension in up to 1,000 liter bioreactors, using synthetic medium and disposable materials.

“The grant of the status of the pharmaceutical manufacturing establishment is a major achievement for THERAVECTYS. 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,” said head of Quality Assurance, Amel Hadri.