Viral clearance capacity by continuous Protein A chromatography step using Sequential MultiColumn Chromatography

Area of Science:

• Biopharmaceutical Manufacturing
• Downstream Processing
• Viral Safety Evaluation

Background:

• Biological protein therapeutics, like monoclonal antibodies (MAbs), require robust downstream processes for consistent quality and efficient production.
• Viral safety is a critical attribute for biopharmaceuticals, necessitating thorough evaluation of viral clearance capabilities.
• Protein A chromatography is a standard initial capture step for MAbs, effective in removing impurities and contributing to viral clearance.

Purpose of the Study:

• To investigate the impact of batch versus multicolumn Protein A chromatography on viral clearance efficiency.
• To evaluate the viral clearance performance of Novasep Sequential MultiColumn Chromatography (SMCC) technology for MAbs.
• To assess viral distribution across purification cycles and columns in continuous chromatography.

Main Methods:

• Small-scale Murine Minute Virus (MMV) spiking experiments were conducted.
• Protein A chromatography was performed in both batch and multicolumn (SMCC) modes.
• Viral reduction factors (RF) and distribution were analyzed for both methods.

Main Results:

• Protein A chromatography using SMCC technology showed no statistically significant difference in viral reduction compared to batch processing (RF of 3.7 log10 vs. 3.8 log10).
• Similar viral distribution was observed across purification cycles and columns in both batch and continuous modes.
• The study confirmed that continuous Protein A chromatography using SMCC technology maintains efficient viral clearance capacity.

Conclusions:

• Continuous Protein A chromatography with SMCC technology provides comparable viral clearance to batch processing for MAbs.
• The implementation of continuous chromatography does not compromise viral safety, a critical quality attribute.
• This approach offers manufacturing efficiency and flexibility while ensuring product quality and safety in biopharmaceutical production.