The use of fresh Protein A resin for each product campaign for manufacture of toxicology supplies represents a significant investment in both monetary costs and personnel time.  This investment could be effectively reduced by the reuse of resin across multiple different product campaigns.  In this paper we investigate the possible risks associated with such a strategy, specifically untoward changes in column performance and material carryover between product cycles.  Several mAb and Fc-fusion molecules were evaluated on a single MabSelect Protein A column over multiple cycles.  Column performance was monitored throughout the study and blank runs were utilized to detect possible carryover between the different product cycles.  Finally, various cleaning techniques were investigated to reduce carryover between product cycles.  An optimized method which effectively reduced carryover with minimized impact to the resin and reduced processing time was identified.

Reuse of MabSelect protein A resin for RegTox manufacture: Feasibility and optimization

245th National Meeting (2013)

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