Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

November 1, 2018
François Coutard

Dr. François Coutard was bioengineering unit manager at the Bioengineering unit, LFB Biomanufacturing.

,
Nick Hutchinson

Dr. Nick Hutchinson was technical content marketing manager at Sartorius Stedim Biotech.

,
Eve DePauw

Eve DePauw is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

,
Ronan McCarthy

Ronan McCarthy is senior downstream process scientist at the Bioengineering unit, LFB Biomanufacturing.

,
Ludovic Bouchez

Ludovic Bouchez is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

,
Isabelle Uettwiller

Dr. Isabelle Uettwiller is head of validation lab, Confidence Validation Service at Sartorius Stedim Biotech.

,
Amélie Boulais

Amélie Boulais is process development consultant, Integrated Solutions Marketing at Sartorius Stedim Biotech.

BioPharm International, BioPharm International-11-01-2018, Volume 31, Issue 11
Pages: 23–28, 44

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.

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Peer-Reviewed

Submitted: Nov. 7, 2017
Accepted: April 18, 2018

About the authors

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.

Article Details

BioPharm International
Vol. 31, Number 11
November 2018
Pages: 23–28, 44

Citation

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.

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