MilliporeSigma - Viral Safety - 19

Viral Safety

Laying the Foundation for Viral Safety
testing. "[It's] a really hard assay to do,"
noted Julie Murrell, Ph.D., head of cell
therapy bioprocessing, MilliporeSigma.
"It takes a while to do it, [and] it takes
a skilled operator to make the call on
whether or not a cell is infected" with
adventitious virus.
In contrast, Next Generation Sequencing
(NGS) offers a nondirected, completely
agnostic approach that makes it a powerful tool for virus detection. It's taken
a while for the technology to make a
home for itself in the industry. Both
the high computational power and the
extensive bioinformatics required to
transform sequencing data into useful
information remain drawbacks of the
technology. But, unlike directed methods,
NGS can detect novel viruses without
a priori knowledge. "The universe of
viruses is large, and new viruses are
constantly being identified or discovered," said Dr. Murrell, "so what we're
testing for today might be different
than what we're testing for in
the future."

Scientist involved in performing cell line characterization testing.

19

| October 1, 2017

The discovery and development of
biologics offers hope to many patients,
but only with security of supply. The
shortage of medication caused by the
Vesivirus contamination in 2009 highlighted the criticality of viral safety to
the industry and patients alike. While
biopharmaceutical companies work
toward establishing better methods

to ensure viral safety, they are also
ushering in a new wave of novel
therapies for diseases with an unmet
need, like rare genetic conditions and
advanced cancers. Even as companies
work to address the viral-safety challenges these therapeutics bring with
them, "The risk-benefit ratio is still very
much in the balance of benefit to the
patient," Dr. Rook reminded us.
As these new modalities advance and
expand to include a broader spectrum
of indications, Dr. Rook is confident that
manufacturers will mature and grow
with them to ensure a safe product:
"[Viral-safety strategies are] going to
evolve. We're not going to stand still.
We'll see these kinds of advances, and
they'll be needed as the use of these
types of therapies expands." n
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