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.
Journal: Food and Bioproducts Processing - Volume 98, April 2016, Pages 327–332