MIT spinout designs gentle process for billions of engineered cells in minutes

Kytopen has engaged Cambridge Consultants to co-develop the first Flowfect system using continuous fluid flow combined with electric fields

MIT spin-out company Kytopen has engaged Cambridge Consultants to co-develop the first Flowfect system. Flowfect is a scalable, gentle process that yields billions of high-quality engineered cells in minutes.

The new system will streamline the engineering of a wide array of human and human-derived cells for use in next-generation cell therapies, with the goal of expanding access to powerful new living medicines.

Kytopen’s non-viral Flowfec technology uses continuous fluid flow combined with electric fields for high efficiency delivery of payloads such as mRNA, DNA, and CRISPR. The technology is compatible with a variety of cells, including iPSCs, primary T cells, and other human hematopoietic cells, being developed for immuno-oncology and gene editing applications.

This first system, considered an “alpha” device, will represent a leap forward in the emerging cell therapy space, enabling therapeutic partners to realise improved transfection throughput and scalability, while maintaining cell health and function.

non-viral Flowfec technology uses continuous fluid flow combined with electric fields for high efficiency delivery of payloads such as mRNA, DNA, and CRISPR

Paulo Garcia, CEO and Co-Founder of Kytopen, said: “The standalone system will be made available to select biotech and pharma partners to evaluate using their proprietary cell-payload combinations and existing workflows.”

Garcia explained that the company selected Cambridge Consultants for their expertise in product development following medical device guidelines, with deep understanding of the non-viral cell therapy industry.

Mike Dunkley, Senior VP at Cambridge Consultants, said: “Kytopen’s Flowfect technology has been developed from the ground up to deliver high-performance transfection of cells in both R&D and clinical manufacturing scenarios using identical core technology. The combined benefit of improved performance and faster scale-up that this approach delivers will help cell therapy pioneers tackling the challenges of high cost and manufacturing quality associated with currently available technology.”

Technology

The core technology was developed in the laboratory of Professor Cullen Buie at MIT. Subsequently, Buie and Kytopen CEO and Co-Founder Paulo Garcia joined MIT’s ‘The Engine’, an ecosystem of “tough tech” companies, to fully realise the technology’s potential.

Having demonstrated rapid and high-performance cell transfection in continuous flow, Kytopen recognised the benefit of engaging with a proven development partner to take this technology off the bench and into a fully designed, closed system. This system will be a pre-production prototype, used by pharma partners to demonstrate Kytopen’s new approach in the development and manufacture of cell therapies.

The technology is compatible with a variety of cells, including iPSCs, primary T cells, and other human hematopoietic cells

Cambridge Consultants was chosen due to its deep expertise in emerging cell therapy manufacturing and its ability to provide rapid turnkey development of the instrument, building on a decades-long history in regulated medical device development. Kytopen also valued Cambridge Consultants’ local proximity, in Boston MA, enabling close collaboration with their in-house engineering and biology teams during this co-development effort.

Cambridge Consultants works with ambitious businesses seeking to develop the radical new devices behind the commercialisation and scale-up of new therapies. This strength is underpinned by multidisciplinary teams, with expertise in biology and device development, as well as deep market knowledge. As a result, Cambridge Consultants is able to generate radical and new solutions that enable its clients to deliver faster access to emerging therapies.

Cell therapies

Cell therapies are a new category of living medicines with curative potential.

Cells are collected from a patient, genetically modified to create highly personalised therapies, and then reinfused into the patient. A small number of these therapies have moved from clinical trials to market approval, but the industry must address challenges in manufacturability, scalability and cost if the full potential for patients is to be realised.

The Kytopen team recognised this opportunity and has developed an elegant solution that both fits within the manufacturing process and has the potential to improve current approaches.

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