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MabSelect SuRe Chromatography Media

Source: GE Healthcare Life Sciences

MabSelect SuRe Chromatography Media

MabSelect SuRe (Superior Resistance) is a member of the MabSelect family of affinity chromatography media for the capture of monoclonal antibodies (MAbs) at process scale.

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Datasheet: MabSelect SuRe

MabSelect SuRe (Superior Resistance) is a member of the MabSelect family of affinity chromatography media for the capture of monoclonal antibodies (MAbs) at process scale. MabSelect SuRe is composed of a rigid, high-flow agarose matrix and alkali-stabilized protein A-derived ligand. This ligand provides greater stability than conventional protein A-based media under the alkaline conditions used in cleaning-in-place (CIP) protocols. The enhanced alkali stability of MabSelect SuRe improves process economy; cleaning can be performed with cost-effective reagents such as sodium hydroxide, which improves process economy and product quality.

Key performance characteristics of MabSelect SuRe are:

  • Novel, alkali-stabilized protein A ligand allows the use of 0.1–0.5 M sodium hydroxide for CIP
  • Improves product quality and reduces overall costs
  • Novel ligand design gives enhanced protease resistance resulting in lower ligand leakage
  • Generic elution conditions for different monoclonal antibodies enables platform approach to purification
  • High dynamic binding capacity (DBC) reduces process time and amount of medium used
  • High-flow agarose matrix allows processing of large volumes of feed

 

The MabSelect SuRe ligand was developed by protein engineering of one of the IgG-binding domains of Protein A. Amino acids particularly sensitive to alkali were identified and substituted with more stable ones. The final construct is a tetramer of the engineered domain with a C-terminal cysteine, which enables single-point attachment to the matrix.

The ligand is produced by validated fermentation and downstream processes and the entire production process is free of components of mammalian origin. The resulting highly purified ligand is immobilized to the agarose matrix through a chemically stable thio-ether linkage.

The toxicology of the MabSelect SuRe ligand has been investigated in a toxicity study and is reported in Application note 11-0011-64. Although a high dose of the ligand was administered, no toxic effects of the ligand were observed.

MabSelect SuRe is stable under alkali conditions and has been tested for up to 200 cycles of CIP using 0.1 M NaOH. The combination of low ligand leakage and high DBC together with the high-flow matrix makes MabSelect SuRe an excellent choice for purification of MAbs at process scale.

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Datasheet: MabSelect SuRe

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