Terumo Blood and Cell Technologies, (Terumo BCT), a medical technology company, published a new protocol in a paper demonstrating expanded capabilities for its Quantum system to unlock rapid CAR-T cell expansion.
The protocol consolidates the processes of T cell activation, lentiviral vector transduction and expansion of CAR-T cells in a single Quantum system, simplifying procedures that have been highly variable and dependent on a skilled workforce. The protocol demonstrated enhancement in manufacturing efficiency, with a two-fold increase in transduction efficiency over manual culture and the ability to consistently produce over 12bn CAR-T cells in seven to eight days.
This automated workflow represents a strategic collaboration between Terumo BCT and Eureka Biotechnology Co., Ltd. Together with Quantum, the workflow leverages Terumo BCT’s Spectra Optia Apheresis System for initial cell collection along with Eureka’s CellSep PRO technology for cell washing and its EULV system for lentiviral vector production. The 3-in-1 protocol improves operational efficiency not only through streamlining processes but also by adopting GMP-friendly designs, such as serum-free culture conditions — eliminating related lot variability and contamination risks.
The promise of CAR-T cell therapies has been hampered by the challenges of manufacturing them at both commercial and clinical scales. One key challenge has been the tradeoffs needed to ensure quality: The longer T cells are outside the body, the worse their efficacy may be. But speeding up manufacturing can also impact efficacy, because crucial subtypes like T memory cells have specialized expansion requirements. The new protocol, published in Cytotherapy, shows that an automated workflow leveraging the Quantum system’s hollow-fiber perfusion technology can produce a therapeutic dose with significant proportions of the needed T cell subtypes.
“Our team developed this protocol with patients front of mind, with the goal of ensuring more people will have better access to the most effective therapies possible,” said Wenyan Leong, director of APAC commercial and global strategic partnerships for cell and gene therapies at Terumo BCT.
“This has long been the goal for our work in CAR-T cell therapies. Our platforms and partnerships are aimed at simplifying and improving the entire manufacturing process in a market-relevant manner. With decades of experience in cell collection through our apheresis technologies, we are excited to extend our expertise beyond cell collections by offering integrated solutions that support the entire cell and therapy journey, from collection to manufacturing.”
The serum-free, 3-in-1 activation-transduction-expansion protocol is currently being evaluated by several cell therapy developers to simplify their CAR-T manufacturing processes, shorten production timelines and reduce overall costs. Terumo BCT will continue to strengthen partnerships and provide relevant solutions to the cell and gene therapy market by shaping standards of care and improving patient outcomes.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
