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Current issues in validation of chromatography.

Chromatography has now been used successfully for more than 20 years to provide the requisite purity for biologicals, but there remain some issues of concern. These issues include carryover and cleaning validation, potential for contamination by microorganisms, potential leachables, and resin lifespan. Compounding these issues is the fact that chromatography media have a very large surface area, and it is not always clear what is occurring at the surface. Furthermore, there are multiple, interactive operating parameters that have the potential to influence chromatographic performance.