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Dr. FranÃ§ois 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.
AmÃ©lie Boulais is process development consultant, Integrated Solutions Marketing at Sartorius Stedim Biotech.
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
The potency of recombinant proteins such as monoclonal antibodies remains typically unaffected by detergent-based virus inactivation treatments because detergents tend to target lipids and lipid derivatives rather than proteins. Virus inactivation treatments that use detergents are robust with respect to temperature, which allows these steps to be performed at room temperature without thermoregulation. In this two-part article, the authors describe the testing performed to demonstrate the applicability of single-use mixing technology for a virus inactivation step performed using detergent.
for a PDF of the article.
Submitted: Nov. 7, 2017
Accepted: April 18, 2018
Ronan McCarthy is seniordownstream process scientist, François Coutard was bioengineering unit manager, and Eve DePauw and Ludovic Bouchez are downstream process technicians; all at the bioengineering unit at LFB Biomanufacturing. Nick Hutchinson was technical content marketing manager, Isabelle Uettwiller is head of validation lab, confidence validation service, and Amélie Boulais is process development consultant, integrated solutions marketing, all at Sartorius Stedim Biotech.
Vol. 31, Number 11
Pages: 23–28, 44
When referring to this article, please cite as R. McCarthy, et al., “Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies),” BioPharm International 31 (11) 2018.
Related Content:Manufacturing, Monoclonal Antibodies | Manufacturing | Peer-Reviewed Research | Downstream Processing | Quality/GMPs | Viral Clearance | Manufacturing, Biologics | Manufacturing, Separation and Purification | Manufacturing Equipment, Downstream Processing | Quality Control/Quality Assurance