Establishment of mammalian cell expression systems for the production of essential low cost protein reagents for development of rapid diagnostics

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The current SARS-CoV-2 pandemic has highlighted the need for access to rapidly produced, reliable diagnostics with the required sensitivity and specificity at a cost that makes these widely accessible to lower and middle income (LMICs) as well as higher income countries. Protein based diagnostic development and manufacture is reliant upon the availability of key protein based reagents that are critical components of these tests. Such tests may need to be manufactured in their millions to billions a year and thus a secure and sufficient supply of authentic and low cost protein reagents is required. For example, for a simple Malaria lateral flow test, 3 different protein reagents are required in 10-500 mg quantities per million tests with an anticipated need of 400 million tests per annum. Some of these reagent proteins must be made in cultured mammalian cell systems to be correctly folded, assembled and modified in order to ensure they can function with the highest possible specificity and sensitivity in diagnostics. Although there are some protein reagent expression systems for production of recombinant proteins from mammalian cells commercially available, these have been refined and developed largely for the expression of high-value proteins to use as drugs to treat a range of diseases and conditions. Access to such systems involves prohibitively high costs that in turn make the use of these essential reagent proteins to manufacture diagnostics in the necessary high volume problematic. There is thus a massively unmet need in terms of access to mammalian cell recombinant protein reagents at a cost that allows their application into commercially viable diagnostics.The project described here will establish technologies, knowhow and systems within a leading UK diagnostics company, Mologic, for the rapid production of recombinant protein reagents in cultured mammalian cell systems, at sufficient amounts, quality and cost to be viable for application into low cost rapid diagnostics for distribution in both developed and developing countries. This will secure reagent provision for development and manufacture of diagnostics and also provide the ability to generate new essential protein reagents swiftly in response to current and emerging needs at a cost that allows their application into diagnostics.