Evaluation of a New Multimodal Anion Exchange Resin for Emerging Biotherapeutic Process Challenges

Описание: Multimodal chromatography has a history of providing value for biopharmaceutical separations. Ligands that enable binding based on both charge and hydrophobic interactions provide more opportunity for effective separation of multiple product- and process-related impurities. However, more diverse protein therapeutics and evolving expression systems present separation challenges that may not be easily addressed by commercially available multimodal resins.

As an alternative to current multimodal anion exchange (MMAEX) resins with quaternary ammonium groups, Bio-Rad’s new Nuvia™ wPrime 2A Resin offering provides MMAEX functionality with a weak anion exchanger.

This webinar will discuss several molecules that were prioritized for high-throughput evaluation of Nuvia wPrime 2A Resin, including an IgG1 monoclonal antibody (mAb), IgG4 mAb, and a bispecific antibody (bsAb), with extra focus placed on proteins with low isoelectric points (pI) and known strong binding to alternative MMAEX resins.

High-throughput screening in flowthrough mode was performed to assess product binding across a broad operating space. One resin was scaled up and further evaluated using miniature columns to assess impurity removal. Results indicate strong aggregate and host cell protein clearance in flowthrough mode across a range of conditions, including effective removal of some high-risk host cell proteins. Compared to MMAEX resins with Q functionality, low pI proteins bound less, allowing higher yields. Moving forward, Nuvia wPrime 2A Resin can be a promising polishing option for diverse protein therapeutics, with protein properties guiding experimental design.

Key Takeaways:
• The ability to modulate the resin's charge state provided a wide‑design space.
• Screening results showed improved yields and reductions in impurities compared to traditional strong ion exchange and strong AEX‑HIC resins.

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00:00 - Introduction
00:53 - Presentation Start
01:54 - Nuvia™ wPrime 2A Intro
02:43 - Molecule Identification for Study
04:34 - Existing Process Challenges
05:57 - High-throughput Plate Screening
10:34 - Miniature Column Testing
11:57 - IgG1 Case Study
14:53 - Bispecific Antibody Case Study
17:06 - IgG4 Case Study
18:36 - Conclusion
19:33 - Acknowledgments
20:15 - Q&A

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Presenter: Michael Rauscher, MS, Associate Principal Scientist, Process R&D Enabling Technologies, Merck & Co., Inc.

Michael Rauscher is an associate principal scientist at Merck & Co, Inc. After working in biologics process R&D on development of several biotherapeutics, he now works in the process R&D enabling technologies organization. His areas of interest include chromatography process development and ways to accelerate it, including high-throughput experimentation and modeling to inform experimental design. He obtained a master’s degree in chemical engineering from Rutgers University and a bachelor’s degree in biochemistry from Purdue University.

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