MilliporeSigma - Viral Safety - 7

Viral Safety

Advances in Upstream Technologies Reduce
Viral-Contamination Risks
Technologies such as high temperature
short time (HTST ) or virus filtration
designed specifically for upstream media
components provide alternatives for
upstream viral safety.
In considering the future direction of the
cell lines used in biologics production,
Dr. Kayser believes that modified and
engineered versions of the CHO line will
be the protein synthetic factory of choice
for the foreseeable future. "CHO cells
have proven to be a very successful tool
in protein drug production," he stated.
"Yes, there are alternatives that people
are thinking about, but certification
of a new cell line is a costly and timeconsuming process and there would
have to be a powerful incentive in order
to embark upon this course of action."

Virus-risk reduction may be one of those
powerful incentives.
Dealing with adventitious agents in
culture systems is a work in progress.
"We are always trying to find process
changes that will save costs and ultimately lower the economics of drug
production," Dr. Kayser asserted. "The
field is constantly evolving, and new
adventitious-agent threats are always on
the horizon. I foresee there will be advances introduced in the near term that
companies will employ to control viral
and other contaminating agents."

Focus on Biosafety Issues
"In advising customers on production
issues, we employ what we refer to as

To date there have been no
instances of disease-causing
organisms transmitted through
biotechnologically designed
therapeutics.
7

| October 1, 2017

The mechanism of action for viral resistance in a Centinel
Intelligent Virus Defense™ modified CHO line.
http://www.GENengnews.com
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