• GMP facility expansion supports progression to Clinical Trials

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GMP facility expansion supports progression to Clinical Trials

Nov 05 2021

Quell Therapeutics has expanded operations to develop and scale production of its multi-modular engineered Treg cell therapies for clinical trials at the Cell and Gene Therapy Catapult (CGT Catapult) in Stevenage UK.

Currently on track to begin the Phase 1/2 “LIBERATE” trial with its lead candidate QEL-001 in the first quarter of 2022, the study will be the first Treg based therapy in transplantation aiming to free patients from all systemic immune suppression, the company said.

“In the two years since we launched Quell in 2019, a key part of our strategy has been to build a world-leading manufacturing capability for our engineered Treg product candidates that includes both expert talent and dedicated GMP infrastructure,” said ceo Iain McGill. “Our agreement with CGT Catapult is an important strategic step that gives us the flexibility to scale our production capacity, which is crucial to the success of our business both near term, as we prepare for our first clinical trial with QEL-001, and longer term, as we advance our pipeline of novel engineered Treg cell therapies in neuroinflammatory and autoimmune diseases.”

“The Stevenage CGT Catapult Manufacturing Innovation Centre is a proven model that enables emerging cell and gene therapy companies to further develop their own GMP manufacturing capability at one of the world's premier centres for the development of advanced therapies. I am very excited about this collaboration, which forms a key pillar of our process development, manufacturing and supply strategy,” added Bernd Schmidt, VP Product Delivery at the company.

The CGT Catapult was established to bridge the gap between scientific research and full-scale commercialisation to ensure life-changing therapies can reach patients throughout the world. As well as the manufacturing development suites, collaborators work together with CGT Catapult on the development of raw materials supply, quality control testing, cryostorage, logistics, track and trace and integration into the wider supply chain.

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