Terumo Blood and Cell Technologies launches study with BioCentriq® to generate public CAR-T cell data using Terumo BCT’s CGT manufacturing platforms

Data will detail how the Terumo BCT’s Quantum Flex® Cell Expansion System and Finia® Fill and Finish System with BioCentriq’s LEAP™ Advanced Therapy Platform can help accelerate delivery of CAR-T therapies to patients

LAKEWOOD, Colo., USA – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, and BioCentriq, a clinical-phase Cell Therapy CDMO (contract development and manufacturing organization), announced the next phase of their collaboration working to demonstrate the capabilities of Terumo BCT's automated cell and gene therapy platforms to accelerate CAR-T cell development. On the heels of BioCentriq's LEAP™ Advanced Therapy Platform launch in June, the companies aim to generate and publish the first publicly available data on rapid CAR-T cell manufacturing using Terumo BCT's Quantum Flex and Finia platforms. The study is designed to show how quickly a cell therapy company can generate large volumes of high-quality CAR-T cells. The workflow being developed is lower in complexity and rapidly GMP-translatable owing to the synergies between Terumo BCT's technology and process expertise supplied by BioCentriq.

"Collaboration is key to progress in the cell and gene therapy industry, and we are committed to helping meet the urgent patient need," said Kathie Schneider, Director, Global Commercial Lead, Cell Therapy Technologies at Terumo BCT. "From the beginning of our collaboration in 2021, we have been aligned with BioCentriq in our shared efforts to enhance manufacturing for the next generation of cell therapies. This makes them a natural partner to help demonstrate the unique capabilities of our hollow-fiber perfusion technology and Finia platform."​​

CAR-T cells in autologous therapies are made by engineering a patient's own T cells to fight their cancer, then growing enough to make a dose. Terumo BCT's Quantum Flex hollow-fiber perfusion technology provides a cell culture environment where cells gain continuous access to fresh media, waste removal and gas exchange, ensuring optimal conditions for the weeks-long cell therapy production process, which may accelerate development and manufacturing. Earlier this year, Terumo BCT presented data* showing the Quantum Flex expanded 6 million unmodified CD3+ T cells to over 2 billion viable cells in just eight days. Now, Terumo BCT aims to share the first public data demonstrating how our platforms can be utilized in a commercial-ready CAR-T workflow.

This month, Terumo BCT will transfer protocols for optimizing CAR-T cell expansion and final formulation for two of its platforms — Quantum Flex and the automated Finia Fill and Finish System — previously installed at BioCentriq's Monmouth Junction, N.J. facility. BioCentriq's experienced team will then perform several runs to confirm the robustness of the protocols, generating data directly from the devices using Terumo BCT's Cell Processing Application (CPA). Once complete, the combined CPA and cell analytics data will be presented at relevant industry conferences next year.

"Integrating cutting-edge technology like Terumo's Quantum Flex with BioCentriq's LEAPTM process platform for CAR-T cell therapies could help reduce development and scale-up timelines by 75% and ultimately, bring these promising cell therapies to patients," said David Smith, Ph.D. and Vice President of Development at BioCentriq. "The results of this study will give CAR-T therapy developers data they can reference as they evaluate the potential of process platforms to accelerate their timeline and reduce their costs."