Continued insights into virus clearance validation across continuous capture chromatography.

Area of Science:

• Biopharmaceutical Manufacturing
• Chromatographic Separation Science
• Viral Clearance Studies

Background:

• Multi-column chromatography (MCC) offers economic and process advantages over batch methods.
• Scalable viral validation models are crucial for clinical and commercial adoption of MCC.
• Existing viral validation for continuous capture chromatography (CaptureSMB) requires supplementation.

Purpose of the Study:

• To assess retroviral (X-MuLV) and parvovirus (minute virus of mice) clearance in CaptureSMB.
• To develop and validate a surrogate model for MCC viral validation.
• To evaluate the impact of resin age and column loading on viral clearance.

Main Methods:

• Performed viral validation studies under current Good Laboratory Practice (cGLP) guidelines.
• Developed a surrogate batch chromatography model mimicking CaptureSMB loading.
• Utilized aged resin and varied column loading in the surrogate model for clearance assessment.

Main Results:

• Validated a surrogate model for simplifying MCC viral validation.
• Demonstrated retro- and parvovirus clearance in CaptureSMB.
• Assessed the influence of resin lifetime and overloading conditions on viral clearance mechanisms.

Conclusions:

• The validated surrogate approach significantly simplifies MCC viral validation studies.
• This strategy provides a robust method for regulatory filings in continuous biomanufacturing.
• The findings support the broader implementation of continuous chromatography in bioprocessing.