Monoclonal Antibody Purification: A Two-Step Approach Using a Strong AEX-HIC Mixed-Mode Resin

Monoclonal antibodies (mAbs) increasingly form the majority share of the product pipeline of major biopharmaceutical companies. Challenges in the purification of mAbs include reducing production cost, developing robust processes for both product purity and viral clearance, and integrating upstream and downstream processes. Traditional mAb purification platform include three chromatography steps. Protein A chromatography is first used for capture of the product, followed by two chromatography steps to remove host-cell proteins, DNA, charged variants, and aggregates. Alternatively, a well-optimized chromatography step with Nuvia™ aPrime 4A Media, a mixed-mode chromatography resin, can eliminate an entire step of the process, allowing the development of a two-step strategy following capture using protein A. This two-step strategy decreases production costs significantly by reducing process time, buffer consumption, media costs, while at the same time increases product yield. Key Takeaway: • Implementing a two-step chromatography strategy can significantly reduce production costs and increase product yield in mAb purification. #pharmaceutical #biopharma #chromatography --- Presenter: Marian Magdy R&D Purification Manager, Minapharm Pharmaceuticals Marian Magdy is a biopharmaceutical professional with almost 16 years of experience in the industry. A pharmacy graduate from 2001, Marian began her career at the Central Administration of Pharmaceutical Affairs, where she worked until 2008. In 2009, she joined Minapharm as a downstream processing specialist in the research and development lab, advancing through the ranks to be the head of the downstream department starting 2019. In 2025, she was promoted to be the manager of the department. Today, Marian leads the development of the downstream process of several projects including monoclonal antibodies, hormones, and vaccines. She also contributed in the technology transfer and the upscale of several projects to the commercial scale. Connect with Bio-Rad Online: Visit Bio-Rad's Website → http://www.bio-rad.com/ Follow Bio-Rad on LinkedIn →   / bio-rad   Follow Bio-Rad on Instagram →   / bioradlabs   Follow Bio-Rad on Facebook →   / biorad   Subscribe to Bio-Rad for the latest breakthroughs in life science research and clinical diagnostics. ©2025 Bio-Rad is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions. All trademarks used herein are the property of their respective owner.