Lakewood, Colorado, - Terumo Blood and Cell Technologies (Terumo BCT) and Akron Bio have completed a collaborative study demonstrating the equivalency between research-use-only (RUO) and Good Manufacturing Practices (GMP)-grade fibronectin for expanding mesenchymal stem cells (MSCs) on the Quantum Flex™ Cell Expansion System. Conducted at Terumo BCT's Lakewood site, this study paves the way for therapy developers to scale MSC-based therapies from research to clinical manufacturing, streamlining the path to market. Full results have been published in Cytotherapy.1
The study confirms that Terumo BCT's Quantum Flex platform, paired with Akron Bio's GMP-grade virus-inactivated fibronectin reagent, provides a scalable and compliant solution for MSC expansion, essential in developing therapies in regenerative medicine. A two-passage process was employed to capture real-world MSC-based processes more accurately.
The data demonstrate that developers can transition from RUO reagents to Akron's GMP-grade reagents without altering process outcomes, addressing a significant challenge for MSC-based therapies in terms of regulatory compliance and production consistency. Results indicate that no statistically significant differences were observed across key metrics, ensuring MSC quality and adherence to International Society for Cell & Gene Therapy (ISCT) standards throughout scale-up.
This collaboration addresses one of the longstanding bottlenecks for MSC therapy developers: the transition from RUO to GMP-grade fibronectin. With Quantum Flex and Akron Bio's compliant reagents, developers now have a roadmap to scale up MSC-based therapies from early research stages through clinical trials and into commercial production.
"As suppliers of critical ancillary materials, it is vital that we meet cell and gene therapy developers' need for quality and consistency, mitigating potential sources of chemistry, manufacturing and controls (CMC) risk to enable a seamless transition from research to clinical manufacturing," said Ezequiel Zylberberg, VP of Corporate Development at Akron Bio. "The data presented in this study demonstrate the compatibility of Akron's fibronectin with Terumo BCT's novel automation platform, offering Quantum Flex users a robust substrate to accelerate development."
This advancement will help enable faster, more reliable commercialization options for therapy developers where GMP-grade fibronectin supply has been a hurdle. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has provided eligibility confirmation to Akon’s GMP fibronectin (PMDA notification no. 1205004), confirming compliance with requirements for animal- and human-derived materials defined in the Japanese Standards for Biological Raw Materials (JSBRM).
"This is another milestone demonstrating our commitment to the cell and gene therapy sector to provide flexible solutions for both adherent and suspension cell types," said Veerle d'Haenens, General Manager, Global Therapy Innovations at Terumo BCT. "The Quantum Flex platform, distinguished by its hollow-fiber bioreactor technology, is among the few devices that support automated expansion of both cell types."
1 Frank ND, Zylberberg E, Bello Roufai B, Gibb SL, Miller MM. Good Manufacturing Practice-grade fibronectin for hollow-fiber bioreactor cell manufacture: a mesenchymal stromal cell case study. Cytotherapy. Published online December 6, 2024. doi: 10.1016/j.jcyt.2024.11.011
About Terumo Blood and Cell Technologies
Terumo Blood and Cell Technologies 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 Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 150 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.
We have global headquarters in Lakewood, Colorado, U.S.A., 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 Akron Bio
Akron Bio enables the advancement of cell and gene therapies through its portfolio of cytokines and media supplements, as well as its comprehensive suite of manufacturing services, including the production plasmid DNA, precision gene editing tools, recombinant proteins and specialized reagents. Akron partners with advanced therapy developers, providing them critical materials and services at the scale, level of compliance, and with the regulatory support necessary to drive novel treatments from discovery to commercialization, thereby addressing critical unmet needs in the patient community. For more information, please visit www.akronbiotech.com.
About the Quantum Flex™ Cell Expansion System
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, from process development through manufacturing. The platform has the flexibility to process autologous and allogeneic applications, as well as viral vector and exosome production, across multiple bioreactors sizes, allowing for process efficiencies in batch size.
The Quantum Flex system's 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. Quantum Flex 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.
Quantum Flex™ is either registered trademarks or trademarks of Terumo BCT, Inc. in the United States and/or other countries. See TerumoBCT.com/trademarks for details.