French regulator halts manufacturing at HIV-focused biotech
- In response to a failed facility inspection, the French National Agency for Medicines and Health Products Safety (ANSM) has suspended manufacturing operations at a Paris facility of the biotech Theravectys. The company will be banned from producing two products for one year, dating from September 7, 2015.
- A November inspection by ANSM turned up 45 deficiencies, including five critical and 17 major deficiencies which ranged from insufficient monitoring to improper clean room qualification.
- The manufacturing facility, which is based in a suburb of Paris, is a lentiviral vector manufacturing plant used to produce Phase 3 clinical trial supplies of biologics. The company has been developing an HIV vaccine and also manufactures intiviral vector-based medicines and CAR-T therapies.
The response from Theravectys has been comprehensive. In response to the regulatory action, the company stopped production, rejected two manufactured investigational batches from last year, and withdrew its authorization request.
Theravectys has been working on developing an effective HIV vaccine. So far, the company has tested its lead vaccine candidate, THVO1, in Phase 1/2. Thirty-eight patients with HIV have been enrolled in Belgium and France in order to assess safety and immunogenicity.
In addition to HIV, the company plans to launch initial trials for its leukemia vaccine candidate.
Theravectys aims to be a leading vaccine company by 2025. For now, however, the focus is on regulatory remediation.
- Regulatory Affairs Professional Society French Biotech’s Manufacturing Operations Suspended by ANSM