March 26, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
French clinical development biotech Theravectys will be hiring up to 25 people over the next year as it fills up its new manufacturing plant in Paris, the company told BioSpace exclusively on Thursday.
Theravectys recently announced that the new plant had been granted approval by the French National Agency for Medicines and Health Products Safety (ANSM) to begin producing lentiviral vectors for clinical development purposes, 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.
As such, Head of Quality Assurance Amel Hadri told BioSpace the company will be looking to hire skilled life sciences workers to help the company begin producing its therapeutic vaccines and immunotherapies.
“The company will be hiring to fill up the new space,” Hadri told BioSpace. “[It will be] an estimated between 20 to 25 people for upstream and downstream production, as well as quality control.”
Theravectys is privately-owned, fully-integrated discovery and clinical development biotech spin-out from the Pasteur Institute.
ANSM granted the status of a pharmaceutical manufacturing establishment to Theravectys’ new site, which will fulfill the firm’s internal clinical development program needs, in addition to those of strategic pharmaceutical partners.
Theravectys says it 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.
“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 Hadri.
The production site is designed in compliance with GMP and ISO standards and has several independent production suites, including upstream and downstream process rooms, an aseptic filling suite. It also includes a logistic zone that allows for GMP storage at various temperatures ranging from -80°C to 25°C and a quality control laboratory.
The new Theravectys plant will be able to handle up to 24 active batches annually. Human cells will be cultured in suspension in up to 1,000 liter bioreactors, using synthetic medium and disposable materials. Proprietary specific quality controls have also been developed, such as RCL, lentiviral vector quantification, residual DNA characterization.
“With the opening of our GMP manufacturing plant, the exclusive worldwide Intellectual Property (IP) license 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 Chief Executive Officer Renaud Vaillant.
BioSpace Temperature Poll
U.K.-based GlaxoSmithKline filed a WARN letter in late February with the state of Pennsylvania indicating another 150 people would be laid off in its commercial and research and development group near Philadelphia. BioSpace wants to know if you think Pharm Country will do what it takes to keep biotech jobs in the area?
