MilliporeSigma - Viral Safety - 28

Viral Safety Tutorial

Utility of GMP Next-Generation
Sequencing (NGS) for Biosafety
Assessment of Biological Products
Colette Côté Ph.D., Lakshmi
Viswanathan, Sindy John,
and Audrey Chang, Ph.D.
The advent of next-generation sequencing
(NGS), also referred to as massively parallel or
deep sequencing, affords a radically different
approach to the challenge of identifying and
characterizing known and unknown agents
(sequences) with precision and sensitivity.
By delivering significantly more data than
traditional Sanger-based sequencing methods,
NGS opens a range of possibilities for the
analysis of diverse DNA and RNA populations.
NGS does not require any prior knowledge
of the sample sequence; the technology is
capable of detecting all sequences in a sample,
whether known or not. An NGS library is
constructed from sample nucleic acid and
then sequenced (Figure 1). Comparison of a
sequence to target sequences or to libraries
of known reference sequences using bioinformatics programs reveals identities. Identification of novel sequences is made possible
by virtue of homology to known elements/
sequences.
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| October 1, 2017

By combining custom sample preparation
with tailored sequencing and bioinformatics,
NGS is ideal for the characterization of biological products (e.g., viral vaccines/products,
raw materials, cell lines used in biomanufacturing, and final drug products [Figure 2]) as
part of a Quality by Design (QbD) approach.
NGS is also particularly well suited for biosafety testing, including the identification
of unknown contaminants in biological
samples or systems (e.g., those that result in
bioreactor/fermentor failures or unexpected
morphological changes/cell death during
cell culture). In such instances, a rapid investigation, combined with the ability to detect
contaminants without bias or prejudice, is
essential and NGS can be the critical first step
for contamination remediation.
NGS continues to prove itself, not only as a key
supplementary tool, but also a key alternative method to address testing requirements
specific for virus-based therapeutic products.
Virus-based therapeutic products (Figure 3)
are viruses that are converted into therapeutic
agents by reprogramming them to treat

Figure 1.

Figure 2.


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