The firm halted production and rejected two test batches made at its facility in Villejuif, Paris last year following an inspection by ANSM, the French Agency for Medicines and Health Products, in November.
According to the inspection report – made public on the EudraGMDP website this week – the regulator raised concerns about equipment used for media fill tests, various analytical methods and the fact the facility lacks a sample area for incoming materials.
ANSM originally deemed the facility to be GMP compliant last March, just 12 months after Theravectys sought approval.
One-year plan
Theravectys develops lentiviral vector-based vaccines and chimeric antigen receptor (CARs) and T-cell receptor (TCR)-based cell therapies. Its lead product – a HIV vaccine – entered a Phase I/II clinical trial in 2014.
The firm told us neither of the rejected batches made in Villejuif had been sent to study sites, explaining that: “Just before the ANSM audit, the batches produced were already under a deviation and they couldn’t be released or use for a clinical trial.”
It added that: “Our team is currently working on a one year plan to respond to ANSM and to remove the provisional suspension.”
No CMO
Theravectys was not the only French cell therapy developer ordered to halt manufacturing last year.
In June, ANSM told TxCell to suspend production at its facility in Besancon for GMP violations.
TxCell responded by asking Belgian contract manufacturing organisation (CMO) Masthercell to help it produce trial supplies.
The CMO completed validation batch of the Crohn’s disease cell therapy Ovasave this month according to TxCell, which said it plans to restart a halted clinical trial of the cell therapy – codenamed CATS29 – this year.
Theravectys does not intend to use the same approach.
The Paris firm told us “as our next clinical trial won’t be launched soon, we don’t intend to seek for a CMO” and adding that the “suspension doesn’t affect our ongoing R&D programs.”