MilliporeSigma - Viral Safety - 10
Viral Safety Feature
Viral Safety in
Monoclonal Antibody
Manufacturing
Various Technologies to Prevent,
Detect, and Remove Virus Contamination
Angelo DePalma, Ph.D.
The significance of viral safety is apparent throughout the biopharmaceutical production process. The
ultimate goal is to protect patients from pathogenic
viruses, and biopharmaceutical manufacturers need
to demonstrate viral safety and validate viral
clearance capability of the manufacturing process
before market approval.
the biotherapeutic product while minimizing
the possibility of virus entry into the system. In
downstream purification, virus removal or
inactivation is accomplished by a combination
of orthogonal or complementary approaches that
include chromatography, chemical inactivation,
and filtration.
Viral safety is critically important in both upstream
and downstream processes. Factors to consider in
upstream processes include: choice of expression
system, degree and type of genetic manipulation of
those cells or organisms, and how the cell culture is
run. All approaches are selected to efficiently produce
For this article, we turn to four experts from
MilliporeSigma, all with unique perspectives on the
various technologies that assure that biotherapeutic
protein products not only comply with requirements
for cGMPs and expectations of regulators, but ultimately
provide the highest level of patient safety.
10
| October 1, 2017
Uniqueness in
Addressing Viral Safety
Listen Now
David Beattie, Ph.D.
Head of Bioprocessing
R&D, MilliporeSigma
http://www.GENengnews.com
Table of Contents for the Digital Edition of MilliporeSigma - Viral Safety
Contents
MilliporeSigma - Viral Safety - 1
MilliporeSigma - Viral Safety - 2
MilliporeSigma - Viral Safety - Contents
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