ReNeuron to automate stem cell stroke therapy production for Phase III trial
The system – the Cellmate – will be used to make ReNeuron’s CTX stem cell therapy at its clinical and commercial-scale manufacturing facility in Pencoed,Wales.
ReNeuron said the Cellmate system will allow staff to seed, culture, and harvest cells while minimising manual interaction with the cultures, which it said would enable production of a stem cell therapy that is “of consistent quality and is reproducible from batch to batch.”
CTX is being developed for the treatment of patients who have been disabled by a stroke or critical limb ischemia. Automating production of the therapy is the key to the next stage of clinical development as ReNeuron engineering head, Jasmin Kee explained.
“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” Lee said.
“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.”
ReNeuron has been using TAP’s CompacT SelecT automated cell culture system in a pilot project in collaboration with researchers at the Loughborough University. The plan now is to scale up the production process using the Cellmate at the Pencoed facility.
Kee added: “For manufacturing our stem cell therapies at scale, Cellmate was the system of choice because it is a proven, validated, automation platform for adherent cell culture used in GMP facilities globally to produce licensed products.
“TAP Biosystems also has a long established support team that can help us ensure the system performs optimally over its lifetime.”