Viral clearance using disposable systems in monoclonal antibody commercial downstream processing

Area of Science:

• Biotechnology
• Biopharmaceutical Manufacturing
• Downstream Processing

Background:

• Protein A affinity chromatography is a standard for monoclonal antibody (mAb) purification.
• Polishing steps are critical for removing product-related impurities, host cell proteins (HCPs), DNA/RNA, and viral contaminants.
• Ensuring product purity and patient safety necessitates effective impurity removal and viral clearance.

Purpose of the Study:

• To introduce the implementation of three disposable systems in a commercial mAb downstream processing workflow.
• To present viral clearance data for these disposable systems.
• To discuss the advantages, disadvantages, and cost-effectiveness of disposable systems in biopharmaceutical manufacturing.

Main Methods:

• Implementation of depth filtration as a disposable polishing step.
• Application of membrane chromatography in a disposable format.
• Integration of nanometer filtration technology for impurity removal.
• Evaluation of viral clearance capabilities of the discussed disposable systems.
• Analysis of application advantages, disadvantages, and cost implications.

Main Results:

• Demonstrated viral clearance efficacy of the evaluated disposable systems.
• Identified specific advantages and disadvantages for each disposable technology in a commercial setting.
• Provided a comparative cost analysis for the implementation of these systems.

Conclusions:

• Disposable systems are viable alternatives or complements to traditional chromatography for mAb polishing.
• These systems contribute to enhanced product purity and robust viral clearance, ensuring patient safety.
• The choice of disposable system depends on a balance of performance, cost, and specific process requirements.