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This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
Single-use technology offers a number of benefits over traditional stainless-steel equipment, but manufacturers must be confident that single-use technology is appropriate for their most critical and aggressive processing steps. In this study, the use of a single-use mixing technology was evaluated and characterized for the performance of a detergent-based virus inactivation step during a monoclonal antibody production process.
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Submitted: Nov. 7, 2017
Accepted: April 18, 2018
Dr. Ronan McCarthy is senior downstream process scientist; Dr. François Coutard was bioengineering unit manager; Eve DePauw is downstream process technician; and Ludovic Bouchez is downstream process technician; all are at the Bioengineering unit, LFB Biomanufacturing. Dr. Nick Hutchinson was technical content marketing manager; Dr. Isabelle Uettwiller is head of validation lab, Confidence Validation Service; and Amélie Boulais is process development consultant, Integrated Solutions Marketing; all are at Sartorius Stedim Biotech.
Vol. 31, Number 10
When referring to this article, please cite as R. McCarthy, et al., “Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies,” BioPharm International 31 (10) 2018.