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Dr. François Coutard was bioengineering unit manager at the Bioengineering unit, LFB Biomanufacturing.
Dr. Nick Hutchinson was technical content marketing manager at Sartorius Stedim Biotech.
Eve DePauw is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.
Ronan McCarthy is senior downstream process scientist at the Bioengineering unit, LFB Biomanufacturing.
Ludovic Bouchez is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.
Dr. Isabelle Uettwiller is head of validation lab, Confidence Validation Service at Sartorius Stedim Biotech.
Amélie Boulais is process development consultant, Integrated Solutions Marketing at Sartorius Stedim Biotech.
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.
BioPharm International
Vol. 31, Number 10
October 2018
Pages: 26–33
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.
Related Content:
Manufacturing, Monoclonal Antibodies | Manufacturing | Manufacturing, Aseptic Processing | Downstream Processing | Manufacturing Systems, Single-Use | Quality/GMPs | Viral Clearance | Manufacturing, Biologics | Manufacturing, Separation and Purification | Quality Control/Quality Assurance