MANUFACTURE OF RECOMBINANT PROTEINS WITH SAFE AND VALIDATED CHROMATOGRAPHIC SORBENTS

Purification of recombinant proteins to achieve homogeneity, purity, c onsistency and potency as required for therapeutic proteins and in viv o diagnostics is performed under stringent and validated conditions. A s liquid chromatography is one of the major technologies used for this purpose, it has to be carried out according to special regulatory gui delines. One of the reported aspects is the long-term consistency of a chromatographic process and validation of its operation; other aspect s described are more sorbent orientated. In-place cleaning and sterili zation are also very important aspects, the efficiency of which is dep endent on the chosen working conditions and the chemical nature of the sorbents. Drastic cleaning may deteriorate the chromatographic matric es, releasing chemicals that may contaminate the biologicals of intere st, while modifying the behaviour of the chromatographic columns. More over, 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 separat ions into consistent, effective and safe production processes for biol ogicals.