Downstream Process Intensification With Novel Chromatography Resins For Enhanced mAb Purification

The evolution of the monoclonal antibodies (mAbs) market, since approval of the first mAb more than 30 years ago, has dramatically changed patient care. Advances in technology as well as knowledge about antibody engineering have brought forth a wide range of targeted therapies to address previously unmet medical needs.

While early production processes rendered only low titers and poor purification yields, there has been substantial progress over the last several years to increase upstream process titer. Unfortunately, this has also led to a strain on existing downstream purification technologies. Although implementation of continuous unit operations has provided some relief, downstream processing (DSP) still presents a major bottleneck in the production of therapeutic antibodies.

One area of focus is the challenges related to Protein A affinity chromatography. While it has become the go-to capture step for the purification of mAbs, Protein A resin is also one of the biggest costs during mAb manufacturing. Limitations related to process economy as well as efficiency call for innovative solutions that can help address these critical issues.

Using the J.T.Baker® BAKERBOND® PROchievA™ protein A affinity resin with select additives, Avantor has designed an integrated mAbs downstream purification process to enable significant throughput improvement while removing critical impurities. When used in conjunction, these technologies represent a highly efficient process to obtain monoclonal antibodies for use as therapeutics.

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Authors

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.

Dr. Jonathan Fura

Manager, Research & Development

In his current role, Jonathan focuses on developing technologies that are utilized to advance the development and manufacturing of antibody-based biopharmaceuticals and diagnostics. Jonathan holds a Ph.D. in chemistry with a focus on developing immunomodulation therapeutic strategies.

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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.