Theravectys’ Mfg Facility Approved by French Authorities
Theravectys, a clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapies, reports that its manufacturing plant has been granted the status of a GMP pharmaceutical manufacturing establishment, 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.
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, Theravecty will produce cGMP lentiviral vectors for its first Phase I/II clinical trial in oncology (adult T leukemia/lymphoma induced by HTLV-1) and for its differentiated CART-cell-based immunotherapy upcoming clinical trial.
The production site is designed in compliance with GMP and ISO standards and consists in several independent production suites, including upstream and downstream process rooms, an aseptic filling suite, and a logistic zone that allows for GMP storage at various temperatures ranging from -80Â°C to 25Â°C. Additionally, the installation includes a quality control laboratory. The plant has a full annual capacity of 24 active batches. Human cells will be cultured in suspension in up to 1,000 liter bioreactors, using synthetic medium and disposable materials. Theravectys proprietary specific quality controls have been developed, such as RCL (replication-competent lentivirusâ€“the validation of the non-replicative nature of the vector), lentiviral vector titration, and residual DNA characterization. These controls have been fully internalized for better product qualification and more efficient batch releases. Some recent manufacturing accomplishments include the development of a stable cell line to increase production yield, the implementation of an improved lyophilization process leading toward a more stable final product, as well as the design and the validation of new, specific and proprietary quality controls.
Alone and in collaboration with partners, Theravectys is planning to initiate two additional Phase I/II clinical trials in oncology in 2015.