MilliporeSigma - Viral Safety - 29

Viral Safety

Utility of GMP Next-Generation Sequencing (NGS) for Biosafety Assessment of Biological Products
disease. They can be grouped by application:
* Viral vaccines-viruses designed to prevent
replication and elicit an immune response
* Oncolytic virotherapy-viruses that selectively
target cancer and tumor cells and elicit an
antitumor immune response
* Viral gene therapy-viruses that deliver therapeutic genes to cells with genetic malfunctions
* Viral immunotherapy-viruses that introduce
specific antigens to a patient's immune system
Plenty of regulatory guidance exists around the
manufacture of viral-based medicinal products.
FDA and EMEA guidance documents and
reflection papers outline testing strategies
and recommendations. While use of NGS is
not specifically defined, it may be inferred
under use of "state-of-art" technologies.

and the requirement for producing neutralizing
antisera, required for many traditional assays.
NGS offers opportunities for circumventing some
of these challenges by offering a consistent and
sensitive method compatible with a diverse
range of products to test for and identify
adventitious virus (Figure 5).

Figure 3.

Specific NGS Applications for Virus
Product Safety and Characterization
One key application of NGS is identity testing
and variant detection, which is of great value
when large or difficult-to-sequence genomes
are evaluated, or when structural and rare
variants are involved (Figure 6).

Challenges for Traditional
Testing of Viral Products
Traditional tests for adventitious virus are lengthy
(e.g., sterility, 14 days; mycoplasma, 28 days;
[Figure 4] and RCR, 28 days). Although they may
detect a contaminant, they generally do not
directly identify it. Often, only small lots with
limited sample volumes of viral-based therapeutic
products are produced, resulting in limited
availability of starting material for process,
product, and test-method development.
Another testing challenge for these types of
products is the lack of reference standards

| October 1, 2017

Figure 4.

Figure 5.

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