Feature Article: Regeneration Studies Of Anion-Exchange Chromatography Resins

Chromatography columns can become contaminated by a variety of protein and nonprotein species during a purification campaign. Consequences of column contamination include an increase in backpressure, loss of signal resolution, altered product yield, and medium discoloration. Common chromatographic contaminants include

• residual proteins
• nucleic acids
• lipids
• endotoxins
• viruses and bacteria
• metal ions.

Generally, methods for cleaning-inplace (CIP) and sanitization-in-place (SIP) of chromatographic resins are selected based on the interplay and relevance of three factors: ease of operation, historical experience, and performance requirements. In most cases, a column decontamination method chosen by a laboratory forms the basis not only for process validation, but also for subsequent scale-up.