ニュースルーム
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.
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.
Turning biological innovation into business value
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 Flowfect™ 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.”
編集者へ
About Kytopen
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 Flowfect™ 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
ケンブリッジコンサルタンツとキャプジェミニについて
ケンブリッジコンサルタンツについて
ケンブリッジコンサルタンツは、画期的な製品開発、知的所有権の創出や供与、技術的な難題に対するビジネスコンサルティングを、世界中のお客様に向けて行っています。市場初となる製品の立ち上げや新規市場参入、新技術導入による既存市場の拡大など、お客様がビジネスチャンスを成功へと変えるお手伝いを60年以上にわたり継続してきました。英国ケンブリッジ、米国ボストン、東京、シンガポールに、エンジニアや科学者、数学者やデザイナーを含む800名以上のスタッフを擁し、医療機器、ライフサイエンス、産業機械、エネルギー、消費財、流通、通信、インフラストラクチャなど、多様な分野におけるソリューションを提供しています。
キャプジェミニ・インベントについて
ケンブリッジコンサルタンツは、デジタルイノベーション、コンサルティング、トランスフォーメーションを統合したグローバル・ビジネス・ライン、「キャップジェミニ・インベント」の一員です。キャップジェミニ・インベントは、経営責任者たちの構想、次の一手の策定支援を行います。世界中の60のオフィスと40のクリエイティブ・スタジオにある10,000以上の強力なチームで構成され、戦略、技術、データサイエンス、クリエイティブ設計領域において、市場をリードする専門家集団を組織します。
キャップジェミニ・インベントは、テクノロジーの力を活用して企業ビジネスの変革・管理を支援するパートナーシップにおけるグローバルリーダーである、キャップジェミニの一部門です。キャップジェミニ・グループは、テクノロジーを通して人々が持つエネルギーを解き放つことで、包摂的で持続可能な未来を目指し、日々まい進しています。世界約50ケ国の32.5万人に及ぶチームメンバーから成る、極めて多様的で責任感の強い組織です。キャップジェミニは、55年にわたって積み上げてきた経験と実績そして豊かな専門知識を活かし、クラウド、データ、AI、コネクティビティ、ソフトウェア、デジタルエンジニアリング、プラットフォームなど、急速に進化するイノベーティブなテクノロジーを原動力として、戦略から設計、オペレーションに至るまで、お客様の幅広いビジネスニーズすべてに対応して、お客様から厚い信頼をいただいています。グループ全体の2021年度の売上は、180億ユーロです。
望む未来を手に入れよう
