Improved antibody purification process through use of additives

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Downstream processing involves multiple unit operations including filtration and several chromatography steps that incrementally increases the purity of the target by exploiting the physical and chemical properties. It is critical for therapeutic monoclonal antibodies to have very high purity with low process related impurities like host-cell proteins (HCPs), DNA, leached protein A and aggregates in order to be administered to patients safely.

We have identified a novel approach to improve impurity clearance efficiency of chromatographic steps by modulating the interaction of target protein and/or impurities with ligands on the resins. Protein A resin with high capacity (PROchievA™ ) or mixed-mode HIC resin (BAKERBOND® Poly Hi-propyl) is used for a capture step and additives are screened to reduce the non-specific binding of impurities. Following IEX steps are optimized to increase the capacity and removal of impurities such as residual HCPs, DNA, charge variants, aggregates and leached protein A.

This presentation was given during BPI Downstream Processing + Viral Safety Digital Week, May 24-27, 2021

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Presented by:

Dr. Jungmin Oh

Manager, New Product Development

In her current role, Jungmin leads product and process development projects with multiple biopharmaceutical industry partners, including customized product development for cell and gene therapy customers. She holds a MS and Ph.D. in chemical engineering, specializing in the optimization of a continuous chromatography system.

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.