Cellares and Sonoma Biotherapeutics have entered a collaboration to automate the manufacturing of the latter’s lead cell therapy programme, SBT-77-7101, using the Cellares Cell Shuttle platform.
SBT-77-7101 is described as an autologous CAR-Treg cell therapy currently in Phase I clinical development to treat patients with poly-refractory rheumatoid arthritis (RA).
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These patients with RA have not responded to existing treatments.
Cellares stated that this represents the first time a Treg therapy will be manufactured on the Cell Shuttle platform.
Under the agreement, the company will adapt and automate the SBT-77-7101 manufacturing process from Sonoma Biotherapeutics for use with the Cell Shuttle.
Quality control operations, including in-process and release testing, will also be managed using Cell Q, Cellares’ automated quality control system.
Cellares currently operates its commercial-scale Integrated Development and Manufacturing Organisation (IDMO) Smart Factory in Bridgewater, New Jersey, and reports that sites in Europe and Japan are under construction.
Sonoma Biotherapeutics president, CEO and board chair Stephen Dilly said: “Tregs are uniquely sensitive to the manufacturing process, and the precision of our proprietary process drives their superior function.
“Cellares brings the Cell Shuttle platform and global infrastructure to help us deliver on our clinical ambitions at scale for the hardest-to-treat RA patients.”
Cellares co-founder and CEO Fabian Gerlinghaus said: “Every new cell therapy modality we bring to the Cell Shuttle and Cell Q expands what is possible for the field and for patients in need. Tregs are among the most technically demanding cell types to manufacture reliably.
“We are honoured to partner with SonomaBio, the industry leader in this field, and demonstrate that our platform, which has already been robustly validated for CAR-T therapies in the clinic, can directly translate to Tregs.”
Last month, Cellares and TScan Therapeutics entered an agreement to examine the use of automated manufacturing for TScan’s TSC-101 therapy in patients with acute myeloid leukaemia and myelodysplastic syndromes.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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