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.”
Notes to editors
캠브리지 컨설턴트(Cambridge Consultants)는 혁신적인 제품을 개발하고, 지적 재산권을 창출 및 라이선스하며, 전 세계 고객을 대상으로 기술 중심 문제를 해결하는 비즈니스 컨설팅 서비스를 제공합니다. 캠브리지 컨설턴트는 60년 이상 기업고객이 신기술을 도입하여 업계 최초로 제품을 출시하거나, 새로운 시장에 진출하거나, 기존 시장을 확장하거나, 사업기회를 상업적 성공으로 전환하도록 지원해 왔다. 엔지니어, 과학자, 수학자 및 디자이너를 포함한 900명 이상의 인원이 캠브리지(영국), 보스턴(미국), 도쿄(동경), 싱가포르(싱가포르)의 연구소에서 의료 기술, 산업 및 소비자 제품, 디지털 보건, 에너지 및 무선 통신 등 다양한 업종에 걸친 솔루션을 제공합니다.더 많은 정보를 원하시면, www.cambridgeconsultants.com를 방문하세요.
케임브리지 컨설턴트(Cambridge Consultants)는 캡제미니 그룹의 혁신 컨설팅 브랜드인 캡제미니 인벤트 (Capgemini Invent)의 소속입니다. 캡제미니 인벤트는 CxO가 조직의 미래를 계획하고 구축할 수 있도록 지원합니다. 30개 이상의 오피스와 25개 이상의 창의적인 연구소를 보유하고 있습니다. 캡제미니 인벤트의 7,000 여개의 팀들은 창의적인 설계, 깊은 산업 전문 지식과 통찰력을 바탕으로 미래의 새로운 디지털 솔루션 및 비즈니스 모델을 개발합니다.
캡제미니 인벤트는 그룹의 핵심적인 부문으로, 기술력을 바탕으로 고객사의 비즈니스를 혁신하고 관리하는 데 있어 기업과 협력하는 글로벌 리더입니다. 캡제미니 그룹은한 포용적이고 지속 가능한 미래를 위하기술을 통해 인간의 에너지를 촉발하려는 목적에 따라 매일 발전됩니다. 거의 50 개국에서 270,000 명의 팀원으로 구성된 책임감 있고 다양한 조직입니다. 우수한 50 년 전통과 깊은 산업 전문성을 갖춘 캡제미니는 빠르게 진화하고 혁신적인 클라우드, 데이터, AI, 커넥티비티 소프트웨어, 디지털 엔지니어링 및 플랫폼에 힘입어 전략 및 설계에서 운영에 이르기까지 비즈니스의 전체 폭을 해결할 수 있도록 고객사로부터 신뢰를 받고 있습니다. 캡제미니 그룹은 2020 년 글로벌 매출이 160 억 유로라고 보고했습니다.
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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
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