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

Paper ID Volume ID Publish Year Pages File Format Full-Text
18885 43036 2016 6 PDF Available
Title
Non-infectious virus-like particles for the validation of membrane integrity and column performance in bioprocessing
Abstract

•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.

Keywords
Virus-like particle; Virus removal; Membrane filtration; Anion exchange chromatography; Water treatment; Biopharmaceutical manufacture
First Page Preview
Non-infectious virus-like particles for the validation of membrane integrity and column performance in bioprocessing
Publisher
Database: Elsevier - ScienceDirect
Journal: Food and Bioproducts Processing - Volume 98, April 2016, Pages 327–332
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering