MilliporeSigma - Viral Safety - 15

Viral Safety Feature

Laying
the Foundation for

Viral Safety
Mitigating the Risk of Viral Contamination
in Vaccines, Cell, and Gene Therapies
Meghaan M. Ferreira, Ph.D.
Viral contamination can result in lost product batches,
equipment sterilization costs, and facility shutdowns,
costing biotherapeutic manufacturers millions of dollars. Even more importantly, undetected contamination can compromise patient safety and trust.
In 2009, the discovery of Vesivirus contamination
forced a biopharmaceutical manufacturer to shut
down a manufacturing facility, which caused a severe shortage of expensive, single-supplier enzymereplacement therapies used to treat rare genetic
diseases. The incident highlighted the importance of
having a strong system in place to mitigate the risk of
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| October 1, 2017

viral contamination, as well as a contingency plan in
the unfortunate case that contamination does occur.
In contrast to chemically derived, small-molecule
drugs, biologics are generally produced in animal or
human cell lines, which carry the risk of virus contamination. While cell culture media and supplements for
monoclonal antibody (mAb) production are often
chemically defined, the same is not true for vaccines
and cell- and gene-therapy products, which generally rely on some animal-derived materials for their
production. While a trend toward animal-origin-free
materials has begun, it's not always easy or possible

Raw Material Testing

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Martha Rook, Ph.D.
Head of Gene Editing,
Novel Modalities,
MilliporeSigma

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