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Feature Article: Regeneration Studies Of Anion-Exchange Chromatography Resins

Source: BioProcess International
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By Paul K. Ng and Valerie McLaughlin

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.

Reprinted With Permission From BioProcess International

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