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.