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 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.
Turning biological innovation into business value
Kytopen’s non-viral Flowfect™ 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 realize improved transfection throughput and scalability, while maintaining cell health and function.
Cell therapies are a new category of living medicines with curative potential. Cells are collected from a patient, genetically modified to create highly personalized 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 realized. The Kytopen team recognized this opportunity and has developed an elegant solution that both fits within the manufacturing process and has the potential to improve current approaches. 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 realize the technology’s potential.
Having demonstrated rapid and high-performance cell transfection in continuous flow, Kytopen recognized 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. 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 has become the partner of choice for ambitious businesses seeking to develop the radical new devices behind the commercialization 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.
Paulo Garcia, CEO and Co-Founder of Kytopen, commented: “We are excited to partner with Cambridge Consultants to help us accelerate the engineering of our standalone FlowfectTM System. The standalone system will be made available to select biotech and pharma partners to evaluate using their proprietary cell-payload combinations and existing workflows. We selected Cambridge Consultants for their expertise in product development following medical device guidelines, with deep understanding of the non-viral cell therapy industry that we wish to impact. We anticipate that this will be a step towards securing long-term clinical manufacturing partnerships with therapeutic companies developing the next-generation of cell therapies.”
Mike Dunkley, Senior Vice President at Cambridge Consultants, commented: “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. We’re delighted to be partnering with Kytopen, using our expertise in device engineering and regulated development to accelerate its progress to alpha, and widening access to these revolutionary new therapies.”
About Cambridge Consultants
Cambridge Consultants develops breakthrough products, services and intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 60 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of more than 800 team members, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA), Tokyo (Japan) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, energy and wireless communications.
Visit us: www.cambridgeconsultants.com
About Capgemini Invent
As the digital innovation, design and transformation brand of the Capgemini Group, Capgemini Invent enables CxOs to envision and shape the future of their businesses. Located in nearly 40 studios and more than 60 offices around the world, it comprises a 10,000+ strong team of strategists, data scientists, product and experience designers, brand experts and technologists who develop new digital services, products, experiences and business models for sustainable growth.
Capgemini Invent is an integral part of Capgemini, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 325,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.
Get The Future You Want
Visit us at www.capgemini.com/invent
Kytopen is an MIT spin-out pioneering a novel and non-viral process to engineer human cells (e.g. T cells, NK cells, Macrophages, CD34+ stem cells, and iPSCs) for therapeutic applications in immuno-oncology and genetic disorders. In just one year, the company has demonstrated the ability to successfully deliver genetic information encoded in mRNA, DNA, and CRISPR to a vast array of human cells with high efficiency and high viability. The FlowfectTM System being developed can process billions of cells in minutes while maintaining health and function of the engineered cells. The Flowfect™ technology carefully synchronizes continuous fluid flow with electric fields to eliminate the harmful effects of traditional delivery via static electroporation. Kytopen is unique in that it is determined to improve patients’ lives by enabling therapeutic partners to accelerate discovery with an automated platform while reducing the manufacturing time of these cell therapies from weeks to days. High-quality engineered cell products will ultimately translate into faster and more cost-effective cell therapy access for a range of patients around the world. Kytopen has developed significant economic traction since it spun out from MIT in 2017, generating $750K in pre-seed financing from The Engine, nearly $1M in non-dilutive federal funding from NSF SBIR phase I/II grants, and an additional $3.6M in seed funding from venture capital and angel investors. The Kytopen team has grown to eight full time members, encompassing a broad range of expertise. This dedicated and multidisciplinary team has enabled the rapid demonstration of the potential impact that the FlowfectTM platforms will have in the practice of future medicine by accelerating time to clinic, reducing cost, and providing access to patients suffering from devastating diseases. For more information, visit: www.kytopen.com
For further information, please contact:
VP of Business Development & Partnerships
+1 617 877 9239
Media Relations Manager
+44 1223 392002
USA PR Agency
+1 617 960 8892
UK PR Agency
+44 20 3755 6400
- medical technology
- synthetic biology
- cell therapy