Terumo Blood and Cell Technologies (Terumo BCT) has published a breakthrough protocol in Cytotherapy that consolidates three critical CAR-T manufacturing steps into a single automated platform, potentially transforming the production landscape for these life-saving therapies. The integrated workflow combines T cell activation, lentiviral vector transduction, and expansion on the company's Quantum Cell Expansion System, demonstrating the ability to consistently produce over 12 billion CAR-T cells in just 7 to 8 days.
Enhanced Manufacturing Efficiency
The new protocol achieved a two-fold increase in transduction efficiency compared to manual culture methods while maintaining the generation of vital T cell subtypes, including memory cells that are crucial for therapy efficacy. This advancement addresses a key challenge in CAR-T manufacturing where longer processing times outside the body can compromise cell quality, while rushed production may fail to generate the specialized T cell populations needed for optimal therapeutic outcomes.
"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, Ph.D., Director of APAC Commercial and Global Strategic Partnerships for Cell and Gene Therapies at Terumo BCT.
Integrated Technology Platform
The streamlined process represents a strategic collaboration between Terumo BCT and Eureka Biotechnology Co., Ltd. The comprehensive workflow integrates multiple technologies: Terumo BCT's Spectra Optia Apheresis System for initial cell collection, Eureka's CellSep PRO technology for cell washing, and Eureka's EULV platform for lentiviral vector production. Together, these components form a functionally closed system that operates under serum-free culture conditions.
The adoption of serum-free conditions eliminates lot-to-lot variability and reduces contamination risks, while the closed-system design incorporates GMP-friendly features that improve operational efficiency. The protocol leverages the Quantum system's hollow-fiber perfusion technology to enable what the company describes as "explosive T cell expansion" while maintaining therapeutic quality.
Addressing Manufacturing Challenges
The remarkable promise of CAR-T cell therapies has been constrained by manufacturing challenges at both commercial and clinical scales. The new automated workflow addresses these bottlenecks by simplifying procedures that have traditionally been highly variable and dependent on skilled workforce availability. The protocol's ability to produce therapeutic doses with significant proportions of needed T cell subtypes while maintaining rapid expansion represents a significant advancement in the field.
Market Implementation
The 3-in-1 activation-transduction-expansion protocol is currently under evaluation by several cell therapy developers who are assessing its potential to simplify their CAR-T manufacturing processes. The technology is expected to shorten production timelines and reduce overall costs, potentially expanding patient access to these transformative treatments.
Terumo BCT plans to continue strengthening partnerships and providing solutions to the cell and gene therapy market, building on decades of experience in cell collection through apheresis technologies. The company's approach extends beyond cell collection to offer integrated solutions supporting the entire cell therapy journey from collection through manufacturing.
