Non-infectious virus-like particles for the validation of membrane integrity and column performance in bioprocessing

• VLP technology in industrial water and biopharmaceutical process validation.
• Viral log reduction measurement via reliable VLP ELISA quantitation method.
• Filter membrane integrity successfully measured.
• LRV in chromatography columns determined without using infectious virus.

Effective viral clearance is critical in both water treatment and biopharmaceutical manufacture to protect public health. In this study, virus-like particle (VLP) was used as a surrogate for membrane and column performance assessments. A reliable ELISA method was developed to quantify VLPs with high sensitivity and specificity. Log10 reduction value (LRV) was measured in a scaled-down manner by mimicking the unit operation using VLPs. This study provides a potential to utilise VLPs in the real-time validation on membrane and column performance in water-treatment and biopharmaceutical manufacturing industries.