Affinity chromatography media, MabSelect SuRe™

MabSelect SuRe™ is composed of a rigid, high-flow agarose matrix and alkali-tolerant rProtein A ligand. The ligand has been engineered to provide greater stability than conventional protein A-based media in the alkaline conditions used in CIP protocols. This enhanced alkali stability improves process economy and product quality.

• Alkali-stabilised rProtein A ligand withstands rigorous CIP and sanitisation procedures with 0,1 to 0,5 M NaOH, reducing the risk of product contamination and carryover
• Ligand design gives enhanced protease resistance resulting in lower ligand leakage
• Generic elution conditions for different MAbs enables platform approach to purification
• Improves product quality and reduces overall costs
• Maintained capacity prolongs media lifetime
• High dynamic binding capacity decreases the amount of medium required
• High flow agarose matrix allows the processing of large feed volumes

MabSelect SuRe shares features and benefits of MabSelect such as a rigid, high-flow agarose matrix that ensures excellent pressure/flow properties, low non-specific binding that leads to low impurity levels in the eluate pool, and an oriented ligand coupling for optimal binding capacity. In addition, MabSelect SuRe features an alkali-tolerant rProtein A ligand. This ligand provides greater stability than conventional protein A-based media in the alkaline conditions used in cleaning-in-place (CIP) and sanitization protocols. The enhanced alkali stability of MabSelect SuRe improves process economy and product quality; cleaning can be performed with cost-effective reagents such as sodium hydroxide eliminating the need for expensive and hazardous cleaning agents such as Gua-HCl.

The novel ligand construct of MabSelect SuRe has been proven to have an increased stability towards proteases. Therefore, the level of leakage of the MabSelect SuRe ligand during elution is low. MabSelect SuRe has been demonstrated to give generic elution conditions for different monoclonal antibodies, which is an advantage when designing generic purification platform processes. This feature is also correlated to the construction of the MabSelect SuRe ligand. Available in a range of different bulk pack sizes and convenient pre-packed formats for easy scale-up and process development. As member of the BioProcess media range, MabSelect SuRe meets industrial demands with security of supply and comprehensive technical and regulatory support. The improved process economy derived from MabSelect SuRe as a component in the production of therapeutic MAbs has led to the validation of MabSelect SuRe as a healthymagination innovation.

MabSelect SuRe has an alkali-tolerant rProtein A ligand that allows the use of rigorous and cost-effective CIP and sanitization protocols based on 0.1 to 0.5 M NaOH. Further, the ligand is protease stable leading to lower ligand leakage. MabSelect SuRe is a member of the MabSelect family of affinity chromatography media for the capture of monoclonal antibodies (MAbs) at process scale