TO6 - GENERATING MONOCLONAL CELL LINES, MONOCLONAL ANTIBODIES, AND LABELED MONOCLONAL ANTIBODIES AGAINST HUMAN AND MOUSE COLQ

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NCATS needs Monoclonal antibodies for bioanalytical method development for expression, toxicokinetic and pharmacokinetic studies and immunogenicity assessment of AAV8-COLQ, a platform-based gene therapy drug candidate for the treatment of Congenital Myasthenic Syndrome (CMS). This task order defines the tasks which will be undertaken to produce monoclonal cell lines that generate antibodies with affinity to either the PRAD domain of COLQ or the Human epitope of Human COLQ, and purified monoclonal antibody preparations for this project and documentation suitable for use of these antibody preparations in regulated preclinical and clinical assays.