Protein Purification

Abstract

The Bio-Rad NGC Chromatography System is used for purification in discovery phases to identify lead candidates, development phases in which optimization and processes are established, and again when those processes are transferred to manufacturing. In a cGMP environment, effective sanitization procedures for small-batch production of biopharmaceuticals are required for regulated laboratories. Validating equipment cleanliness is critical in the pharmaceutical industry and of utmost importance to avoid contaminating drug products with microorganisms, viruses, endotoxins, cleaning solution residues, and the like. Contaminating an entire chromatography system with living organisms, followed by full-system decontamination, can verify how well the system can be cleaned and can help to identify problem areas.