Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies
This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
nobeastsofierce /stock.adobe.com
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.
Click
hereto view a PDF of this article.
Peer-Reviewed
Submitted: Nov. 7, 2017
Accepted: April 18, 2018
About the authors
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.
Article Details
BioPharm International
Vol. 31, Number 10
October 2018
Pages: 26–33
Citation
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.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
