MilliporeSigma - Viral Safety - 20

Viral Safety Feature

Keeping Up with

Viral Safety Trends
in Bioprocessing
Next-Generation Sequencing (NGS)
and Quality by Design (QbD)
Kristen Slawinski, Ph.D.
Viral safety is a key component to assuring the safety
of biopharmaceuticals for human use. Manufacturers
need to verify that their products are free of harmful
viruses, while regulatory agencies are tasked with
upholding standards for viral safety for all types of
biopharmaceutical products. As live cells are used to
express the biopharmaceutical product, and many
of the components used in cell growth are of animal
origin, the risks of virus contamination are high.
New technologies and methodologies are emerging
for both producing and testing biopharmaceuticals,
so the industry is entering a new era of viral safety
assurance.
20

| October 1, 2017

The High Cost and Likely Suspects
of Viral Contamination
"If virus is detected anywhere in a biomanufacturing process, the entire process must be shut down
and an intensive investigation embarked upon," says
Bala Raghunath, Ph.D., director of global manufacturing sciences and technology at MilliporeSigma. A
contamination incident in 2009 triggered a facility
decontamination, extensive investigations of root
cause, and penalties from concerned health authorities, not to mention the significant loss in revenues as
a result of the plant shutdown. "This impacted supply

Cell Culture Media
Filtration

Listen Now

Martin Wisher, Ph.D.
Global Head of
Regulatory Affairs
Focusing on the
BioReliance® Portfolio
of MilliporeSigma

http://www.GENengnews.com

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