A proprietary single-cell analytics platform for accelerating biologics manufacturing

项目总结： OneCyte BioTechnologies，Inc.是从麻省理工学院(MIT)剥离出来的 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，可以削减许多 几个月的生物(如治疗性单抗或疫苗)药物开发。一个 生物制药的关键挑战是缓慢的生物制造时间表。世界目前正在经历 发展缓慢的时间表对人类健康和经济的影响 新冠肺炎大流行及其给快速开发和制造数十亿剂新药带来的负担 疫苗和单抗。这突显了加快药品开发和制造的必要性。 OneCyte的单细胞平台技术为细胞生物学提供了前所未有的洞察力 扩大规模；潜在地实现新的治疗方法类别，并加强基本的科学理解。 这项技术的影响将是减少药物开发的时间和成本，以及 提高疗效和安全性。这可以使开发治疗目前无法治愈和罕见的新药成为可能 疾病，目前开发或制造都不可行。除了这个最初的应用之外， OneCyte的技术可以成为一种易于实施的研究工具，增强基本的 了解生物学，或促进细胞功能的工程应用于细胞治疗。 OneCyte正在寻求资金，以扩大创新的单细胞分析能力和屏幕 关于对药物安全和疗效非常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，将单电池技术平台过渡到商业流程。 在目标1.OneCyte将开发和实施创新的单细胞分析，用于更多的PQA， 专注于筛选药品可制造性中不受欢迎的偏差，这些偏差会导致药品减少 循环半衰期和降低的生产产量。 在目标2中，OneCyte将自动化和纵向扩展单细胞数据分析，以实现更好的 药品可制造性的可预测性，以及自动执行商业数据分析流程 必要的最小用户输入。 在目标3中，OneCyte将开发一种可用于制造的热塑性微流控芯片，取代 一种弹性材料。用于单电池工艺的新塑料芯片的验证将是 通过测试电池性能与弹性体芯片进行比较。

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.