TABLE I

Survey Results for the Application of Affinity Capture Chromatography within Biopharma

Utilization of Affinity Capture Chromatography Processes in Biopharma• All survey respondents use an affinity capture resin as a product purification step.
• A majority of respondents, 11 of 14, apply affinity capture as the primary purification capture step.
• A vast majority (13/14 respondents) use standard, off-the-shelf resin types. Examples include MabSelect™ (Select, Xtra, SuRe), ProSep® (vA, Ultra Plus, Ultra-pre-packed).
• Specialized resins may be required in some cases.
• Choice of resin type is product-dependent.
• Mixture of traditional and continuous processing applications.
Process Applications• Resin is product-dedicated.
• Sub-cycles may be employed to complete the purification of one batch.
• Resin may be used in short or long processing campaigns.
• Lifetime is typically limited by maximum number of load cycles.
• Resin may be stored between manufacturing campaigns (some exceptions applied).