TAS::75 0893::TAS RAPID LARGE SCALE PRODUCTION OF PROTEIN THERAPEUTICS

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AWith a long-term objective to efficiently manufacture protein therapeutics, the Contractor developed a mammalian expression vector pATG that incorporates human DNA regulatory elements to render long-term cell line stability, ensures the most stringent selection of high producers, and uses the strongest signal sequence for high level secretory expression without gene amplification. This system shortens mamallina cell line development from 1 year to 4-5 weeks. To make this system user-friendly, in this Phase I study, the Contractor will devise novel ways to further reduce cell line development time to 2 weeks; and demonstrate the robustness of its new system by comparing with commercially available vectors in manufacturing model proteins. The Contractor will provide contract CMO services for generating stable, high-producing CHO cells lines for large-scale production of recombinant antibodies and vaccines.