The Protein Expression Core will provide monoclonal antibodies (mAb) and recombinant chimeric Fc fusion proteins to support all programs of this NCDDG. The Core will provide purified and characterized proteins, suitable for both the in vitro and in vivo analyses. This centralized core will allow for comparative studies among this NCDDG since these agents will be used from equivalent, quality control lots of production. The in vivo feasibility and optimization data generated using the Core-generated reagents will be suitable for including in investigator-initiated INDs submitted to support the clinical trials that arise from this NCDDG program. Each agent will be expressed, purified, and subjected to quality control studies and each agent will be produced under standard operating procedures, tested, and distributed to investigators in the program as needed. Specifically, we are going to express and purify recombinant Fc-fusion proteins and mAbs, perform quality control assays to demonstrate and quantitate bioactivity, perform sterility and endotoxin testing, and and distribute to all investigators.
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