A proprietary single-cell analytics platform for accelerating biologics manufacturing

项目摘要： OneCyte Biotechnologies，Inc.是从马萨诸塞州理工学院（MIT）分拆出来的 推进下一代单细胞技术，以影响药物开发和生物制造。 OneCyte是单细胞蛋白质组学的先驱，正在开发一种平台技术， 生物（例如治疗性单克隆抗体（MAb）或疫苗）药物开发中断数月。一 生物制药关键挑战是缓慢的生物制造时间表。世界目前正在经历 发展时间表缓慢对人类健康和经济的影响， COVID-19大流行及其快速开发和制造数十亿剂新型冠状病毒的负担 疫苗和单克隆抗体。这突出表明需要加快药物开发和制造。 OneCyte的单细胞平台技术以前所未有的速度深入了解细胞生物学， 规模;可能使新的治疗类别，并提高基本的科学理解。 这项技术的影响将减少药物开发的时间和成本，以及 提高疗效和安全性。这可以使开发新的药物，目前无法治疗和罕见的 这些疾病目前还不可能开发或制造。除了最初的申请， OneCyte的技术可以成为一种易于实施的研究工具， 生物学的理解，或促进细胞治疗应用的细胞功能工程。 OneCyte正在寻求资金，以扩大创新的单细胞分析能力和屏幕 对于药物安全性和有效性重要的其他关键产品质量属性（PQA），以及 在SBIR第二阶段结束前，将单细胞技术平台过渡到商业化过程。 在目标1中。OneCyte将开发和实施创新的单细胞测定，用于其他PQA， 重点是筛选药物可制造性中不希望的偏差，这会导致药物 循环半衰期和产量降低。 在目标2中。OneCyte将自动化和扩展单细胞数据分析，以改善 药物可制造性的预测性，以及自动化商业数据分析管道， 最低限度的用户输入。 目标3. OneCyte将开发一种制造就绪的热塑性微流体芯片，取代 弹性体材料。将对用于单细胞工艺的新塑料芯片进行验证， 通过测试与弹性体芯片相比的电池性能来执行。

Project Summary: OneCyte Biotechnologies, Inc. is a spin-out from the Massachusetts Institute of Technology (MIT) advancing next-generation single-cell technologies to impact drug development and bio-manufacturing. OneCyte is a pioneer of single-cell proteomics and is developing a platform technology that cuts many months off biologic (e.g. therapeutic monoclonal antibodies (MAbs) or vaccines) drug development. A key challenge in biopharma are slow bio-manufacturing timelines. The world is currently experiencing the impact of slow development timelines on human health and the economy in the extreme example of the COVID-19 pandemic and its burden of rapidly developing and manufacturing billions of doses of novel vaccines and MAbs. This is highlighting the need for accelerated drug development and manufacturing. OneCyte’s single-cell platform technology provides insight into cell biology at an unprecedented scale; potentially enabling new classes of therapeutics, and enhancing basic scientific understandings. The impact of this technology will be reducing time and cost of pharmaceutical development, as well as improving efficacy and safety. This can enable developing new drugs for currently untreatable and rare diseases, which are presently not feasible to develop or manufacture. Beyond this initial application, OneCyte’s technology could become a readily implemented research tool, enhancing the basic understanding of biology, or facilitating engineering of cell function for cell therapy applications. OneCyte is seeking funding to expand the innovative single-cell analytical capabilities and screen for additional critical product quality attributes (PQAs) important for drug safety and efficacy, as well as transition the single-cell technology platform to a commercial process by the end of SBIR Phase II. In Aim 1. OneCyte will develop and implement innovative single-cell assays for additional PQAs, focusing on screening for undesired deviations in drug manufacturability, which lead to reduced drug circulating half-life and reduced production yield. In Aim 2. OneCyte will automate and scale-up single-cell data analytics towards improved predictivity for drug manufacturability, as well as automate the pipeline for commercial data analytics with the necessary minimum user input. In Aim 3. OneCyte will develop a manufacturing ready thermoplastic microfluidic chip, replacing an elastomeric material. Validation of the new plastic chips for use in the single-cell process will be performed by testing cell performance compared to elastomeric chips.