In
the manufacture of certain pharmaceuticals, viral removal or destruction is a
key part of manufacturing (such as products produced from cell lines or from
blood or plasma, as per ICH Q5A). This requires a combination of viral secure
areas and viral removal steps. In a previous American Pharmaceutical Review
article, this author examined the ways by which viruses can be removed or
inactivated from pharmaceutical products (including solvent-detergent; low pH
inactivation; heat; chromatographic separation; and nanofiltration).
In
terms of detection, nucleic acid-based assays such as Polymerase Chain Reaction
(PCR) and Next Generation Sequencing (NGS) provide rapid and sensitive
detection of adventitious and endogenous viruses in constituent materials and finished
products. This follow-up article considers how viruses can be excluded by HEPA
filtration, thereby minimizing the entry of viruses and viral particles into
cleanrooms. Aspects of this review may also be of interest in the wider context
of the 2019-2020 novel coronavirus pandemic (caused by the virus SARS-CoV-2).
In
relation to this, Tim Sandle has written an article:
Sandle,
T. (2020) Effectivity of HEPA Filters to Remove Viruses from Air Entering Cleanrooms, American
Pharmaceutical Review, 23 (4): 56-58 (
Viral
contamination is a potential safety threat common to all animal- and
human-derived biologics and it follows that ensuring virological safety is
challenging. Contamination of the production system can occur, and the
processes of viral removal are complex and require regular assessment (to avoid
the incomplete inactivation or removal of viruses). A further challenge arises
with creating viral secure areas. As well as the control of materials and
personnel, and important factor in maintaining such an area is through
effective air filtration.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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Pharmaceutical Microbiology Resources