Mar 26 2015
THERAVECTYS, a clinical development biotechnology company that focuses on the development of therapeutic vaccines and immunotherapies, proudly announces that its 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 be used to produce lentiviral vectors for clinical development purposes, from phase I through phase III, and 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.
As a result of the authorization, THERAVECTYS has further strengthened its position as a leader in the lentiviral vectors field and has become fully operational for supplying comprehensive immunotherapeutic treatments that help stimulate and modulate the immune system from the initial vector design to the final release of clinical batches.
“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.
The new facility will be used to fulfill the company’s internal clinical development program needs, in addition to those of strategic pharmaceutical partners. 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 leukemia/lymphoma induced by HTLV-1) as well as for its differentiated CAR-T cell-based immunotherapy programs.
This investment will allow THERAVECTYS 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 production site is designed in compliance 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 is comprised of 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 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, fully internalized for better product qualification and more efficient batch releases.
“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 of THERAVECTYS, Renaud Vaillant.
THERAVECTYS has continued to improve its industrial processes to strengthen its trade secrets and IP. Major accomplishments include the development of a stable cell line to increase production yield improving its lyophilization process, and to implement new specific quality controls.
Discovering how cells reorganize during division