Chief Operating Officer Miguel Forte told BioPharma-Reporter.com TxCell was already looking for a CMO (contract manufacturing organisation) to meet extra production need for an upcoming Phase II trial before the French medicines agency failed its GMP plant in April.
Ovasave, the company’s lead candidate, is an antigen specific regulatory T-cell (Ag-Treg) immunotherapy. Belgian contract development and manufacturing organisation MaStherCell will begin production in Q2 2016 for a Phase IIb trial in refractory Crohn’s disease patients.
ANSM, the French medicines regulator, found unsterile packaging and production conditions at TxCell’s site in Besancon, France in April this year.
It reported several “major deficiencies,” including 30 cases of mould contamination in investigational batches, packaging in aseptic areas which was not sterilised, faults in the site’s quality control system, and poor microbiological monitoring of clean rooms.
The plant was forced to halt manufacturing until it fixes the problems and can reapply for GMP status, which Forte told us is likely to happen in September or October this year.
He said the company has hired external consultants to overhaul the facility. TxCell is retraining its technicians, performing “dummy runs” for aseptic conditions, and has introduced tougher controls on the materials entering clean rooms, Forte said.
TxCell is also looking ahead to manufacturing needs for a potential Phase III study of Ovasave, and has partnered with UK organisation Cell Therapy Catapult on process development and scale-up.
The firm has an orphan disease candidate based on the same T-cell technology. Col-Treg is in early development for autoimmune uveitis, and has Advanced Therapy Medicinal Product status from the European Medicines Agency. Forte told us he expects the Besancon facility to be up and running in time to manufacture small batches of Col-Treg when it begins first-in-man studies.