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Abstract
Purification of recombinant proteins to achieve homogeneity, purity, consistency and potency as required for therapeutic proteins and in vivo diagnostics is performed under stringent and validated conditions. As liquid chromatography is one of the major technologies used for this purpose, it has to be carried out according to special regulatory guidelines. One of the reported aspects is the long-term consistency of a chromatographic process and validation of its operation; other aspects described are more sorbent oriented. In-place cleaning and sterilization are also very important aspects, the efficiency of which is dependent on the chosen working conditions and the chemical nature of the sorbents. Drastic cleaning may deteriorate the chromatographic matrices, releasing chemicals that may contaminate the biologicals of interest, which modifying the behaviour of the chromatographic columns. Moreover, leachable compounds, when present, could have adverse effects in case of high toxicity. Determination of leaching levels and toxicity tests are part of the validation steps to turn chromatographic separations into consistent, effective and safe production processes for biologicals.
Published Version
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