Details of ANSM’s November visit to Theravectys’ facility in Villejuif in Paris were made public last night. The inspectors observed 45 deficiencies from good manufacturing practices (GMP), five of which they described as critical.
The French regulator cited use of standard operating procedures (SOP) that do not comply with GMP principles in the media fill test area as a major problem.
The agency also highlighted (here in French) the lack of a sampling area for incoming materials and failures related to microbial monitoring among its criticisms.
ANSM banned Theravectys from manufacturing its candidate products at the site for one year, back dated to September last year.
Theravectys halted manufacture shortly after the inspection in November and rejected two batches produced at the site.
The firm is a privately-held vaccine developer that spun out of Institut Pasteur.
It specialises in use of lentiviral vectors for the development of therapeutic vaccines and immunotherapies in oncology and infectious diseases.
ANSM originally cleared the Paris facility as GMP compliant in March last year, just 12 months after Theravectys sought approval to use it as a production base for supplies of its vaccine candidates for clinical trials.
At the time the firm said the facility would allow it to control manufacturing costs and timelines and “leverage and mutualize a common production process for both research and clinical development material requirements as well as protect its unique proprietary know-how and trade secrets.”
The plant has an annual capacity of 24 active batches, houses 1,000 litres of bioreactor capacity.
Theravectys did not respond to a request for comment.