Intelligent live cell analysis [ilca] to transform disease management through faster, and more regulatory robust, discovery, manufacture and monitoring of biologic drugs & cell therapies
The detailed analysis of live cells, as shed elements of a human disease process, cell therapies themselves or as factories for the production of biologic drugs, is attracting intense focus globally from diverse companies in automation, imaging, diagnostics and manufacturing. This proposal is made on behalf of a consortium of 3 European SME’s to support the validation and preparation for commercial take-up of the market entry application, Cell Line Development [CLD], of a new transformative technology at the forefront of these areas and is ideally suited for cell line development, antibody discovery, gene editing, cell therapy, antibody engineering and ex-vivo diagnostic workflows. Each workflow provides a dramatic increase in insight, control, speed and cost, ultimately resulting in faster, cheaper and more regulatory robust medicines for European patients.   Biologic drugs are large in size and are manufactured from a single cell selected following an expensive, relatively crude and time consuming process - Cell Line Development. Our technology can select the 'Top' cell using a detailed analysis of the critical quality attributes along with providing complete image recording and documentation of the growth from a single cell [regulatory requirement]. This cell selection and control is essential as all resulting master and working cell banks are used over the entire life‐cycle of the marketed product that can last multiple decades.   This FTI funding will enable market entry and validation & support external fundraising for the wider penetration of the global drug discovery, Cell therapy & ex-vivo diagnostic markets. This is a potentially transformative technology platform in a very large market with 1 current aggressively funded US competitor and our success will ensure competition, continued innovation and most importantly cheaper medicines for European patients.