Regulatory Focus™ > News Articles > French Biotech’s Manufacturing Operations Suspended by ANSM

French Biotech’s Manufacturing Operations Suspended by ANSM

Posted 07 March 2016 | By Zachary Brennan 

French Biotech’s Manufacturing Operations Suspended by ANSM

France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November.

ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The company, which is running clinical trials for an HIV vaccine, says on its website that it aims to be a top-tier vaccine company by 2025.

Among the critical deficiencies, ANSM found that media fill tests were performed with unqualified equipment, the company lacked a sample area for incoming materials and some analytical methods and processes were not validated for a clinical trial which ANSM says has the protocol number of 2015-000845-21, though a search of the EU clinical trials register did not turn up any results.

The company’s lead lentivector vaccine completed a Phase I/II safety and immunogenicity human proof-of-concept study in HIV with 38 patients enrolled at 12 sites in Belgium and France last summer. Other trials were expected to begin in late 2015.

According to the company’s website, Theravectys’ lentiviral vector manufacturing facility is used to produce Phase III clinical trial supplies of biologics and can produce up to 12 active batches per year.

“Following the inspection, Theravectys decided to stop the production on going, to reject the two manufactured investigational batches and to withdraw the authorisation’s request for which the ANSM assessment was on going,” according to the inspection report.

ANSM added that it will suspend manufacturing operations of investigational medicinal products, including quality control testing and batch certification, though storage activities will be allowed. The company did not respond to a request for comment.

Inspection Report


Categories: Regulatory News

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