MilliporeSigma - Viral Safety - 18

Viral Safety

Laying the Foundation for Viral Safety
therapeutic product still relies heavily on scientific
discovery and, as a result, remains a long-term
strategy for most companies.
Screening the product for adventitious viruses throughout the manufacturing process forms the third pillar
that safeguards against viral contamination. Cell therapies in particular may require testing methods with
high enough sensitivity to detect viral contamination,
despite the smaller volume of material available for
testing compared to more traditional therapeutics.
"Classic viral tests are still [used]-they're still
defined, they're still approved, they're still relevant,"

affirmed Alison Armstrong, Ph.D., senior director,
global head of field development services focusing
on the BioReliance® portfolio of MilliporeSigma. "It's
really about where modifications may be applied...
to address whether a virus, and perhaps a novel
virus, is present."

Virus Detection Assays
The amount of knowledge needed a priori to detect adventitious viruses depends on the different techniques
employed. PCR-based methods require a high degree
of homology (usually 95%) to the sequence selected
for testing and may not detect a novel virus, even if it

comes from the same family as the virus of interest.
Culture-based infectivity assays offer a broader range
of detection for nonspecific viral agents. These assays
expose indicator cell lines to a test sample, which then
undergoes an observation period to determine if an
infection event has occurred. However, infectivity assays are not completely agnostic as cell-line dependent
variations in susceptibility to a particular pathogen can
still bias detection.
Testing for adventitious virus with cell-based assays in
viral vaccine products can also be challenging because
the viral vaccine must be completely neutralized before

Novel Virus Detection

Listen Now

Operator installing a single-use bag in a
Mobius® 2000 L single-use bioreactor.
18

| October 1, 2017

Alison Armstrong, Ph.D.
Senior Director,
Global Head of Field
Development Services
Focusing on the
BioReliance® Portfolio
of MilliporeSigma

Mobius® FlexReady solution with smart Flexware®
assemblies for chromatography and prepacked
Chromabolt® chromatography column.

http://www.GENengnews.com

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