mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges.
• The increased upstream titers in mAb production seen in recent years may make the Protein A capture step a bottleneck.
• Protein A columns columns are also more prone to bioburden contamination due to heavy impurity load and weak tolerance for common concentrations of NaOH cleaning-in-place solutions.
This poster presents a newly designed, high-capacity Protein A resin, MabSelect™ PrismA, which offers alkali stability on par with ion exchange and hydrophobic interaction chromatography resins, enabling new possibilities in cleaning and sanitization efficiency to address bioburden risks and process economy. The binding capacity has been increased more than 40% compared to its predecessor MabSelect SuRe LX enabling increased mass throughput and productivity.