Qualification of a Chromatographic Column: Why and How to Do It

FDA has become more knowledgeable about process chromatography — and more demanding about column qualification. In the latest installment of BioPharm International's "Element of BioPharmaceutical Production," five industry experts share their insights o­n how to qualify a chromatographic column. Their advice: Write unambiguous SOPs. Focus o­n reproducibility of column packing. Choose appropriate metrics. And analyze your testing procedures to reduce the chance of erroneous results.

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