MedTech Terumo Blood and Cell Technologies has published a new protocol in a paper, demonstrating the expanded capabilities for its Quantum system.
In the protocol, the company describes how Quantum can unify the T cell activation, lentivirtal vector transduction and expansion of CAR-T cells in a single system, simplifying the production process.
It also reduces reliance on a skilled workforce and enhances manufacturing efficiency, with a 2-fold increase in transduction efficiency over manual culture, as well as the ability to consistently produce more than 12 billion CAR-T cells within 8 days.
Quantum's automated workflow was created in collaboration with Eureka Biotechnology, leveraging Terumo's Spectra Optia Apheresis System for initial cell collection.
Meanwhile, Eureka's CellSep PRO technology is used for cell washing, while its EULV system is harnessed 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.
Overcoming CAR-T manufacturing hurdles
CAR-T therapies have shown remarkable promise in patients with a wide range of cancers, though their growth has been somewhat hampered by their associated manufacturing challenges.
At both the commerical and clinical scales, a key challenge lies in the reduced efficacy of T cells when they are outside of the body.
However, speeding up manufacturing can also impact the efficacy of CAR-T cells, because key subtypes like T memory cells have specialised expansion requirements.
Terumo's new protocol, which is published in Cytotherapy, shows that an automated workflow using the Quantum system's hollow-fibre 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," he concluded.
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.
