- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
MaSTherCell to manufacture TxCell’s lead product Ovasave
29 July 2015 • Author: Victoria White
The contract signed between TxCell and MaSTherCell is a Memorandum of Understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave. These Ovasave batches will be used by TxCell in the ongoing phase IIb trial in refractory Crohn’s disease patients (CATS29 study). The transfer of technology will start immediately. It is intended that first clinical batches could be manufactured as soon as Q2 2016.
In addition, TxCell is currently taking action at its existing pilot Besançon manufacturing unit in order to ensure future compliance with Good Manufacturing Practice (GMP) and recommence full manufacturing activities following a partial, temporary hold at the site. TxCell will then file to reobtain its GMP certificate as production will resume after the GMP certificate is granted back by the French regulator ANSM.
Ovasave clinical batches for the CATS29 study will be manufactured in parallel by MaSTherCell and TxCell’s own facility. As previously disclosed, the Company expects to deliver top-line data from this study in 2017.
MaSTherCell is set to discuss long-term clinical and commercial manufacturing of TxCell’s products
“This strategic relationship with MaSTherCell, a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials, is very important to TxCell,” said Stéphane Boissel, Chief Executive Officer of TxCell. “We have immediately taken the appropriate actions at our manufacturing site in Besançon and the agreement with MaSTherCell should enable us to rapidly increase the efficiency of our manufacturing. This should both speed up enrollment in CATS29 and accelerate development on other products.”
As part of the Memorandum of Understanding with MaSTherCell, TxCell and MaSTherCell also agree to enter into discussion for the long-term clinical and commercial manufacturing by MaSTherCell of Ovasave and other TxCell products. These discussions will take place in Q4 2015.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics