Automated fill and finish expected to improve reproducibility, reduce cost and abbreviate time to market.
Lakewood, Colorado, U.S.A. – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, and Charles River Laboratories (Charles River), a global industry-leading drug discovery, preclinical development, manufacturing and testing solutions provider, announced data from a collaborative project demonstrating the versatility of Terumo BCT's Finia automated fill and finish system in a range of cell and gene therapy (CGT) workflows. The platform was designed to streamline the cooling, aliquoting and packaging steps of cellular product manufacturing, where reproducibility is challenging and cost per failure remains highest.
Fill and finish for CGT products is more complex than for other therapeutics because of the products' personalized nature and short shelf lives. Many CGT products are expanded from patient or donor starting material and, because of this, final product volume can vary dose to dose and from one product to another. Terumo BCT's Finia, the first commercial automated device for CGT fill and finish, has been adopted by therapeutic developers eager to streamline workflows.
Results published in Cytotherapy demonstrate how Charles River and Terumo BCT collaborated to integrate Finia into a Charles River T cell workflow. The study data demonstrates Finia could adapt to process large volumes in series. A 304 mL product containing equal parts expanded cells and cryopreservation media was processed on Finia in four consecutive runs, resulting in 16 product bags — a four-fold increase in capacity, with a total process time of two hours. The system produced highly accurate final volumes, limited impact to cell viability and functionality, and reduced hands-on time. Finia's ability to control temperature for both inputs and the final product limits cell exposure to the cryoprotectant dimethyl sulfoxide (DMSO) which is used commonly in cryoprotectant medias.1
"We commend the work by both teams in demonstrating the broad applicability of Finia for both autologous and allogeneic CGT manufacturing," said Stuart Gibb, Ph.D., Head of Scientific Strategy for Cell and Gene Therapies, Terumo BCT. "Charles River is known as a leader in the field for contract CGT services, and we're thrilled to see them demonstrate their expertise using the Finia platform."
"We are excited by the prospect Finia's automation offers to make CGTs more accessible by lowering costs while accelerating development and manufacturing," said Alex Sargent, Ph.D., Director of Process Development at Charles River. "Through this collaboration, we've shown that an expert team can seamlessly integrate technological advances like Finia into existing workflows, leveraging its flexibility to improve manufacturing without impacting final product quality."
Terumo BCT and Charles River have shared this data jointly in this on demand Cell and Gene Therapy Insights Webinar as well as presented at the 2024 American Society of Gene and Cell Therapy Annual Meeting.
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 the FINIA™ Fill and Finish System
FINIA is a closed, automated system that formulates and aliquots fluids, including cell suspensions, to prepare for cryopreservation — all with the convenience of a benchtop design. The device requires less hands-on time with fewer operators and touchpoints than manual processes while automatically logging events, actions and information in a cGMP-compliant, detailed electronic process record. Controlled cryoprotectant addition, active temperature controls and automated mixing limit the exposure of cells to DMSO to preserve cell health, function and viability.
1Smith T. Optimized fill and finish to limit DMSO's negative impact on T cells. White paper. cellandgene.com. April 2023. https://www.cellandgene.com/doc/optimized-fill-and-finish-to-limit-dmso-s-negative-impact-on-t-cells-0001. Accessed May 3, 2024.
Finia™ is either a registered trademark or a trademark of Terumo BCT, Inc. in the United States and/or other countries. See TerumoBCT.com/trademarks for details.