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However, FDA inspectors discovered a compliance failure when they visited the manufacturing facility two months later

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RBCs that aggregated as the bottom layer were collected and stored at -20C in a cell lysis/protein storage buffer [20 mM Tris, 100 mM NaCl (Amresco, N653), 1X protease inhibitor cocktail (Amresco, M221)] for western blot analysis

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