A partnership involving a medical school, a non-profit organization, and a biotech company have formed a partnership for the development and manufacture of an accessible and commercially viable hematopoietic stem cell (HSC) manufacturing platform for diseases like sickle cell disease (SCD). The alliance combines Trenchant BioSystems’ technology for automating patient-specific cell and gene therapy (CGT) processes, the University of Massachusetts Chan Medical School’s expertise on blood stem cell processes, and Caring Cross’s expertise in increasing patient access.

The collaboration will focus on developing a gene-modified stem cell manufacturing process with Trenchant’s AutoCell automated CGT manufacturing platform that is designed to be scalable and operate at place-of-care in an ISO class 7 environment to increase efficiencies and decrease costs.

A key reason Trenchant BioSystems’ automated CGT manufacturing platform was selected is its use of a microbubble separation approach as an alternative to immunomagnetic bead-based separation for stem cell gene therapies, point out officials at Caring Cross and Chan Medical School. In addition, AutoCell has a small footprint and significantly fewer facility requirements, important factors for lowering the cost of these therapies, adds Jon Ellis, CEO, Trenchant BioSystems.

In the first phase of the collaboration, UMass Chan researchers will work with Trenchant BioSystems to start evaluating blood products to separate stem cells and build the automated gene transfer genetic engineering platform with lentiviral vectors from Caring Cross. In the next post-validation phase, Caring Cross will evaluate the system and process for simplicity and cost before offering it as a potential alternative to its collaborators worldwide. UMass Chan and Caring Cross will conduct preclinical studies to launch a Phase I/II clinical trial of autologous gene-modified HSCs for patients with SCD or beta thalassemia.

The alliance currently plans to hold an INTERACT meeting with the FDA during the first quarter of 2027 and launch the clinical trial later that year.

“Disruptive technologies such as the AutoCell platform that empower us to tap into the immense unexplored runway between current state of the art ex vivo and in vivo blood cell gene therapies stand to significantly expand and improve access to these transformative medicines,” says Jennifer E. Adair, PhD, vice chair and professor of genetic & cellular medicine and director of the Horae Gene Therapy Center at UMass Chan Medical School.

“Caring Cross is dedicated to ensuring the global affordability of advanced therapies, and a key driver for this is the adoption of cell processing platforms that effectively lower barriers to patient care,” notes Boro Dropulic, PhD, executive director of Caring Cross. He is also CEO of Vector Biomed, which also designs and manufactures lentiviral.

“Current cell and gene therapy manufacturing practices are too time consuming and costly to actually deliver CGT therapies to large-scale patient populations,” maintains Trenchant’s Ellis. “Trenchant BioSystems has now released internal and independent data that confirms that its AutoCell platform is integral to the solution to these challenges.”

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