Detection and Quantification of Leached Protein A from Eshmuno® A Resin Using Cygnus F400 Protein A ELISA kit
23 Oct 2014This case study demonstrates the performance of the Cygnus Protein A ELISA Kit with samples containing EMD Millipore’s Eshmuno® A Protein A ligand. The initial feasibility testing demonstrates that the Cygnus F400 Protein A ELISA Kit could accurately measure the Eshmuno® A Protein A ligand. In phase II, the accuracy and precision of the ELISA was assessed using samples from a 3-step antibody purification process. The F400 Protein A ELISA Kit performed within the generally accepted specifications. Based on this testing, the Cygnus F400 Protein A ELISA is qualified for measuring the Eshmuno® A Protein A ligand in a typical downstream process using Eshmuno® A resin. Eshmuno® A resin has a high binding capacity, superior flow capability and excellent batch-to-batch consistency so increases productivity and reliability of results.
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Eshmuno® A Resin
MerckEshmuno® A is a rigid, high capacity Protein A affinity chromatography resin for the purification of Fc-containing proteins, including but not limited to monoclonal antibodies. Eshmuno® A resin can be cleaned and sanitized under acid and alkaline conditions while maintaining high dynamic binding capacity at high flow rates.The Eshmuno® A resin contains a EMD Millipore proprietary ligand. This ligand is recombinantely expressed in E. coli. No animal derived products are used during production. The Eshmuno® A resin is synthesized via immobilization of the ligand on to the Eshmuno® base matrix, which is a rigid and hydrophilic polymer based on polyvinylether.Eshmuno® A Resin Features: Productivity - high binding capacity, superior flow capability, reusability, and low cost of goods (COGS). Product purity - increased aggregate removal, excellent HCP reduction, low leached Protein A, consistent viral clearance, and reduced Fab binding. Scalability - linear scale-up. Reliability - batch-to-batch consistency, GMP manufacturing environment, and continuous regulatory support.