Wednesday 7 September 2022

Optimizing a viral test strategy


Viruses are found in almost every ecosystem on Earth and are the most numerous types of biological entity. As such, viruses pose a challenge to many aspects of biopharmaceutical manufacturing. These challenges not only relate to viruses per se or viruses that pose a particular problem to different cell lines or production processes, but also from the varied nature of viruses themselves – the genetic material (molecules of DNA or RNA that encode the structure of the proteins by which the virus acts); the nature of the protein coat (the capsid, which surrounds and protects the genetic material) and whether or not the virus possess an outside lipid envelope.1 The shapes of these virus particles range from simple helical and icosahedral forms to more complex structures. These geometrically sophisticated architectures are influencing factors where nanofiltration is used as a viral inactivation step. Given the risk presented from both pathogenic viruses in starting materials and from adventitious agents arising during bioprocessing, the testing strategy becomes an essential part of the viral contamination control strategy.



In a previous issue of American Pharmaceutical Review, a strategy was outlined for viral reduction and virus clearance within a facility.2 This companion article considers the testing component of the overall viral strategy.


Sandle, T. (2022) Optimizing a viral test strategy, American Pharmaceutical Review, 25 (4): 46-51


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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