INDIANAPOLIS, March 26, 2021 /PRNewswire/ -- Sexton Biotechnologies, in partnership with Hitech Health and Med Institute, is working towards continued innovations in flexible automation. As cell and gene therapy manufacturers move to close and automate processes, the challenge of integrating existing systems is a pain point for the industry. Flexible automation of traditionally manual process offers a new solution with lower capital expenditures and greater potential for downstream success.
Sexton Biotechnologies is dedicated to providing tools that enhance flexibility and reduce the risk that comes with manual processes. The launch of Sexton's Signata CT-5 provides the first truly flexible fluid management system, capable of integrating multiple processes using the same system. To demonstrate the varied potential of the system, Sexton has engaged Hitech Health and Med Institute to show how it easily connects with other tools used in the manufacturing workflow.
"We're excited to work with these partners to demonstrate how manufacturers can easily integrate separate unit operations in a closed manner using flexible automation systems," said Sean Werner, President of Sexton. "From initial transfer into the manufacturing system through final packaging, the use of these systems provides developers improved control while supporting development iteration. The flexibility allows a user to choose the systems that work best for them, whether it's a platform like CellSeal, the first vial designed specifically for cryopreserved cellular products to be used in an approved commercial cell therapy, or traditional soft-sided bags."
Steve Charlebois, Vice President of Engineering, Regenerative Medicine at Med Institute further points to the importance of the early-stage decision making and its effects on final product.
"We are committed to keeping up with the pace of cell and gene therapy development, to make these lifesaving therapies available to patients," said Steve. "Decisions made early in the development process are critical. Through these strategic partnerships and collaborations, we are able to direct our know-how and experience to address technology bottlenecks that stand in the way of aggressive development and manufacturing timelines. Tackling challenges at each step of development, from ancillary material selection, bioreactor testing, media development, while preserving the principles of closed, flexible, and automated processes, translates to cost-effective, scalable solutions for cell and gene therapies."
Hitech Health is focused on product development, manufacture, launch, and supply of cell and gene therapies. Aoife Duffy, Cell and Gene Therapy Operations Manager, leads a team that has successfully developed multiple cell and gene therapy products.
"We think it is important to collaborate with other companies so that we can add to our expertise in operational activities," said Aoife. "Cell and gene therapy products are expensive to develop and manufacture. Working with Sexton and the Med institute to bring the new fluid management system to the market will help with making processing more efficient. Hitech Health is bringing our extensive operational and GMP Manufacturing expertise to this collaboration. We are expanding our capabilities to cell and gene therapy process development and manufacturing. Additional expertise we bring to the collaboration includes quality, QP approval, and management of supply chain. In the end, we believe that this collaboration will lead to time and cost savings, along with greater downstream success in the manufacture of cell therapy products."
The collaboration between the companies will result in detailed workflows demonstrating capabilities with bioreactors, packaging, formulation, and additional equipment. These efforts are currently underway with publication of workflows expected to begin in early 2021.
ABOUT SEXTON BIOTECHNOLOGIES
Sexton Biotechnologies is a revenue stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy founded in 2019 as a spin out of Cook Regentec, a life science incubator/accelerator located in Indianapolis, IN. Sexton develops purpose-built CGT tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points, and labor costs. Sexton's portfolio includes the fluid handling system, Signata CT-5, CellSeal platform of cryo-storage tools and fill/finish systems, and human platelet lysate growth supplements. More information at www.sextonbiotechnologies.com.
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