Accelerates production at new Advanced Therapy Medicinal Products manufacturing facility in Wales
TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a supplier of cell culture and fermentation systems for the life science industry, has installed its Cellmate automated cell culture system at stem cell therapy firm ReNeuron to produce clinical and commercial stem cell therapies at its new Advanced Therapy Medicinal Products (ATMP) manufacturing facility in Pencoed, Wales.
The Cellmate system will be used initially by ReNeuron to automate T-flask processing of its CTX neural stem cell therapy to treat patients disabled by the effects of stroke and critical limb ischemia. It will allow ReNeuron staff to aseptically seed, culture, and harvest cells while minimising manual interaction with the cultures. This will safely and rapidly provide a stem cell therapy, which is of consistent quality and reproducible from batch to batch.
Dr Jasmin Kee, Head of Engineering at ReNeuron, said: 'For our Phase I and II clinical trials, the production of CTX stem cell therapies is a manual process. As we move into Phase III, we are looking to increase our batch sizes 10-fold while maintaining the quality and reproducibility of our product. We needed a reliable platform that would remove many of the risks of inconsistency when scaling-up.
'After assessing many available technologies, we concluded that for our cells, expansion of our T-flask approach would be the optimum strategy. In collaboration with Cell Therapy Catapult and Loughborough University, we are using TAP Biosystems’ CompacT SelecT automated cell culture system to design a scaled-up process, which can be transferred to the Cellmate.'
Dr Kee added that Cellmate was chosen because it is a 'proven, validated, automation platform for adherent cell culture used in GMP facilities globally to produce licensed products'.