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

Rathore,Anurag;

Publication

Article

March 15, 2003

BioPharm International

BioPharm International-03-01-2003

Volume16

Issue 3

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

Author(s):

Anurag S. Rathore

by Anurag Rathore, Pharmacia Corporation 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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Articles in this issue

Biotech World: India Blossoms

Inside Washington: The Big Shift

Outsourcing Outlook: One-Stop Shops

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

Guest Editorial: Recruiting Biotech Talent

Survival Strategies: How to Purchase COTS Software

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