Feature Article: Cleaning And Cleaning Validation In Process Chromatography

By Gail Sofer and Jonathan Yourkin

During regulatory inspections, manufacturers of biopharmaceuticals and biological products often find attention directed to cleaning and cleaning validation of chromatography resins and multiuse purification systems. Chromatographic resins must either be disposed of or sufficiently cleaned to ensure reproducibility in subsequent cycles. The decision to recycle or dispose of resins is typically driven by cost. The economics depend on unit operation scale, resin cost and compatibility with cleaning agents, feedstream quality, position of the resin in the purification scheme, and stage of product development.

If columns are to be recycled, resin lifetime studies must include assessment of the cleaning on performance after continued use. The cost of validating reuse has been discussed (1). Once a decision is made to recycle, and after a certain number of cycles, replacing resin is often less costly than extending a lifetime study.

Reprinted With Permission From BioProcess International

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