474. A New cGMP Facility To Produce Clinical Grade Batches of Lentiviral Vectors and CAR-T Cell in Europe

Abstract

THERAVECTYS is a Paris-based, privately-owned, fully integrated discovery & clinical development biotech company. We are developping lentiviral vectors for human and veterinary vaccination and immunotherapy applications.We have have proudly achieved the first-ever human vaccination clinical trial conducted with lentiviral vectors with our anti-HIV vaccine candidate. We are now pursuing our clinical development of further therapeutic innovative vaccine candidates, both in oncology & infection diseases. Particularly, our first oncology clinical trial, which targets Adult T-cell Leukemia/Lymphoma virally-induced by HTLV-1, is programmed before Q3 2015. In addition, we are developing our own T-cell therapy programs (CAR and TCR) based on its proprietary new lentiviral-based system allowing a real switch of the production of the CAR or of the TCR by the modified T-cellsTo control costs, respect timelines and maintain the high quality and diversity of all ongoing and future clinical development programs, THERAVECTYS has decided to internalize the bio-production of its lentiviral vectors and the associated quality controls. To achieve this goal, THERAVECTYS has built a GMP facility in compliance with the requirements of regulatory agencies (EMA and FDA). The 340m2 plant is equipped with state-of-the-art bioreactors (from 20 to 1000L), semi-automated downstream skids and a fill-and-finish system to conform to our fully integrated single use process. This process implies a 16day-USP step corresponding to the expansion and transfection of HEK293SF cells, and a 2day-DSP step comprising 3 purifications. This GMP facility will allow us to produce batches from a minimum of 300 up to 5 000 vials complying with up to phase III clinical trial requirements. Additionally, our GMP facility which is composed of defined distinct independent rooms will allow us to develop our current validated technics, lentiviral vector production and CAR T cells engineering, without any cross-contamination.Our Quality Control unit was architecturally designed to house a vast array of analytical equipment. With more than 30 different analytical methods including environmental monitoring of the GMP facility, contaminants evaluation and RCL testing, THERAVECTYS has gained full independence by keeping all analytical and microbiology testing in house.This cutting-edge GMP facility (production and QC unit) had been built in 9 months, and should be operational in Q1 2015 (the certification process is currently underway). It will allow THERAVECTYS to protect its unique and advanced know-how in the manufacturing of lentiviral vectors and CAR-T cells.