BioCentriq(R) presents first public CAR-T expansion data from Terumo Blood and Cell Technologies’ Quantum Flex Cell Expansion System

• Data supporting capabilities to help reduce time-to-market will be shared today at CAR-TCR Europe
• Terumo BCT’s Quantum Flex platform enabled rapid expansion of low seed densities of CAR-T cells to therapeutic dose size

Lakewood, Colorado and Newark, N.J., February 29, 2024 – Today, Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company​, and BioCentriq, a global cell therapy contract development and manufacturing organization (CDMO), will share the first data resulting from its chimeric antigen receptor (CAR)-T cell therapy manufacturing collaboration today at the 7th CAR TCR Summit Europe. The data will demonstrate, for the first time, the ability to rapidly produce CAR-T cells using protocols developed by Terumo BCT for its Quantum Flex and Finia(R) Fill and Finish System platforms, even when starting material is scarce. BioCentriq generated the data on the two platforms, in tandem with its own LEAP(TM) Advanced Therapy Platform, in its New Jersey facility.

Commercial CAR-T therapies have delivered hope to thousands of patients diagnosed with late-stage blood cancers. However, too few patients have been able to access them in part due to laborious and slow manufacturing processes that have proven difficult to scale up. Until now, much of the industry data available has been based on unmodified T cells, which can have different kinetics during an expansion phase than cells turned into a therapy by adding a CAR. The goal of the Terumo BCT and BioCentriq partnership is to improve manufacturing efficiencies and reduce the cost of these life-changing and potentially life-saving therapies.

BioCentriq performed several runs through the manufacturing process after receiving protocols from Terumo BCT to optimize cell expansion in the Quantum Flex and fill/finish in the Finia. Data generated from the devices with Terumo BCT's Cell Processing Application (CPA) demonstrated versatile and rapid cell expansion. To evaluate the platform’s capabilities, a range of starting cell numbers was assessed from 1 million through 15 million cells. These expanded to between 200 million to 2.6 billion in 7 days. As these starting cells often come from patients themselves, who may have difficulty producing enough when ill or in treatment, the partners found that the platform could support sufficient expansion with starting material as low as 1 million CAR-T cells*.

“The key to this study’s success was how BioCentriq’s commercial-ready CAR-T workflow complemented our technology portfolio. The power of this study demonstrates that the Quantum Flex platform is directly relevant for autologous CAR-T. The findings from the dynamic range of starting cell numbers we assessed show that we can expand CAR-T cells not only for adult dosing but also for pediatric and compassionate treatment doses. This is absolutely necessary if cell therapy is to reach more patients” said Stuart Gibb, Scientific Strategy Lead, Medical Affairs, Terumo BCT. “This serves as a compelling demonstration of the power of collaboration in the cell and gene therapy space, while confirming and expanding internal findings.”

“This collaboration takes aim at the manufacturing bottlenecks that have adversely impacted patient access to CAR-T’s and other advanced therapies,” said David Smith, Ph.D., Vice President of Development at BioCentriq. “It demonstrates how BioCentriq is leveraging Terumo BCT’s platforms to shorten manufacturing timelines and accelerate the development of new therapies.”

Smith will present data including growth kinetics, viability, phenotypic analysis, and functionality assay results today at CAR-TCR Europe in London, UK at 10 a.m.

*Data on file

To learn more about Quantum Flex, visit https://www.terumobct.com/quantum.

To learn more about Finia, visit https://www.terumobct.com/finia.

To learn more about, BioCentriq's LEAP(TM) Advanced Therapy Platform, visit https://biocentriq.com/capabilities/leap-advanced-therapy-platform/ 

About Terumo Blood and Cell Technologies 

Terumo Blood and Cell Technologies (Terumo BCT) is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees worldwide believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers. Terumo BCT’s customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers, and private medical practices. Our customers are based in over 160 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending. We have global headquarters in Lakewood, Colorado, along with five regional headquarters, seven manufacturing sites and six innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.

About BioCentriq(R)

BioCentriq is a global cell therapy Contract Development and Manufacturing Organization (CDMO) with a proven track record successfully transferring, developing, and manufacturing, and GMP drug product for use in clinical trials since 2022.

With industry-recognized leadership, scientists, engineers, analysts, and manufacturing specialists, along with established quality systems and modern infrastructure, BioCentriq is a trusted strategic partner for the development and manufacture of both autologous and allogeneic cell therapies and cell-based therapies.

In June 2023, BioCentriq launched its LEAP(TM) Advanced Therapy Platform designed to help cell therapy developers move from contract to clinic in as little as six months. The company was purchased by GC Holdings Inc. of South Korea for USD 73 million in May 2022. Our newly constructed, modern facilities feature flexible GMP manufacturing suites and fully equipped process development, quality control and analytical method development laboratories.

To learn more, please visit www.biocentriq.com and follow us for updates on Linkedin.