A medical technology company, today announced the launch of a bioreactor platform that supports process development through to commercial manufacturing for the cell and gene therapy (CGT) sector.
Terumo Blood and Cell Technologies (Terumo BCT) named its Quantum Flex Cell Expansion System, after identifying the industry’s need for earlier automation to potentially limit additional and time-consuming steps including bridging studies and technology transfers.
The company says Quantum Flex allows developers to complete their early process development on the same platform they will use for manufacturing, creating a cell culture environment where cells thrive. Early process development, it says, may lead to reduced cost and risk of unanticipated process deviations in later phases of clinical trials.
“Collaboration is important in meeting the needs of this fast-moving sector. We worked closely with four customers in our early adopter program to pilot the new Quantum Flex platform,” said Delara Motlagh, General Manager, Cell Therapy Technologies.
“We are building on a legacy of handling fragile cells with targeted investments and solutions designed for the CGT market. The cell culture environment matters so cells can not only grow but thrive. We developed Quantum Flex to provide a scalable, GMP-compliant platform that streamlines cell manufacturing and data management. We strive to deliver high-quality cells with fast cycle time to achieve timely delivery to market, and ultimately to patients.”
Terumo says that Quantum Flex is an automated and functionally closed cell expansion system purpose-built to meet the needs of cell therapy developers throughout their commercialization journey. It says the platform has the flexibility to progress autologous and allogeneic applications, as well as viral vector and exosome production, across multiple bioreactor sizes, allowing for process efficiencies in batch size.
Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “The development of cutting-edge manufacturing platforms is key to the continued success of the highly specialized CGT industry. The Quantum Flex platform represents another advancement which will help streamline processes and accelerate the manufacturing process, making it easier for developers to bring therapies to market.
“We are proud to have consulted with Terumo BCT in the development and design of this platform and look forward to seeing the benefit it may bring to CGT developers and ultimately patients.”
Terumo BCT says its 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 expansion. The Quantum Flex platform also features advanced software to support cGMP compliance, with user authentication, batch records and fleet management features allowing for easy deployment of protocols to multiple systems.
Through collaboration with its customers, Terumo BCT says it continues to bring industry-specific technologies that deliver automation solutions to elevate customers’ processes and to address the urgent needs of the cell therapy industry, from apheresis through to fill and finish.