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.”
ケンブリッジコンサルタンツはアルトラン（Altran）の一員です。 アルトランは、エンジニアリングおよびR＆Dサービスにおいて広く認められた世界的リーダーであり、変革とイノベーションの課題に対応する独自の価値提案をお客様に提供しています。コンセプト創造から産業化に至るまで、アルトランはお客様が明日の製品やサービスを開発するサポートをいたします。35年以上にわたり、自動車、航空、宇宙、防衛および海軍、鉄道、インフラと輸送、産業と消費者製品、生命科学、通信、半導体と電子機器、ソフトウェアおよびインターネット、金融および公共部門など、様々なお客様を支援してきました。今日、アルトランは30か国以上に50,000人を超える従業員を擁し、コンサルティング、デジタルトランスフォーメーション、テクノロジー＆エンジニアリングサービスのグローバルリーダーであるキャップジェミニ（Capgemini）の中核を担っています。キャップジェミニ・グループはイノベーションの最前線に立ち、進化を続けるクラウド、デジタル及び各種プラットフォーム分野で、顧客のあらゆるビジネス機会に対応致します。キャップジェミニは、50年以上にわたり蓄積してきた優れた実績と業界固有の専門知識を基に、戦略から運用まで、一連のサービスを通じて、企業が目指すビジネスビジョンの実現を支援しています。キャップジェミニの信念は、「テクノロジーに関わるビジネス価値は人を通じて具現化される」ことであり、この信念こそが社の原動力となっています。キャップジェミニは、世界約50か国270,000人に及ぶチームメンバーで構成される多文化企業であり、アルトランを含むグループ全体の2019年度売上は、170億ユーロです。People matter, results count.（人にこだわり、成果にコミット。）アルトランの詳細はwww.altran.com をご参照ください。
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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- medical technology
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