Antibody Aggregate Removal by Multimodal Chromatography

Area of Science:

• Biotechnology and Pharmaceutical Sciences
• Separation Science and Chromatography

Background:

• Increasing demand for therapeutic monoclonal antibodies (mAbs) necessitates efficient purification methods.
• Removal of antibody aggregates is crucial for drug safety, efficacy, and regulatory approval in downstream processing.
• Conventional single-mode chromatography methods face limitations in aggregate clearance and process flexibility.

Purpose of the Study:

• To review the application of multimodal chromatography for separating antibody aggregates.
• To analyze commercial resins and prototype adsorbents for aggregate removal.
• To compare multimodal chromatography with traditional single-mode techniques.

Main Methods:

• Exploration of aggregate formation mechanisms during bioprocessing.
• Comparative evaluation of affinity, ion exchange, and hydrophobic interaction chromatography.
• Assessment of commercial multimodal chromatography resins based on aggregate removal efficiency, binding capacity, and scalability.

Main Results:

• Multimodal chromatography integrates multiple interaction types (ion-exchange, hydrophobic) for superior aggregate clearance.
• Commercial multimodal resins demonstrate significant potential for efficient and scalable mAb aggregate removal.
• Advancements in prototype resins and multimodal membranes show promise for future applications.

Conclusions:

• Multimodal chromatography offers enhanced process flexibility and improved aggregate removal compared to single-mode techniques.
• This technique is vital for achieving high purity standards required for therapeutic antibodies.
• Continued development of multimodal chromatography is essential for evolving biopurification demands.