Virus validation methods typically involve spiking a known quantity of virus into a scaled-down batch process and measuring clearance. This approach is used for virus filters, chromatographic processes, and virus inactivation steps. However, applying this strategy to continuous processes is impractical due to the large virus quantity needed and potential virus instability. Additionally, evaluating virus clearance over the full range of conditions in continuous processes poses significant logistical challenges.
The proposed work will address a major challenge in connected / continuous processing by
developing a reliable small-scale system capable of accurately evaluating virus clearance.
Capability has been developed to produce a prototype transient inline spiking system that has been demonstrated and tested at several institutions.
Basic design of the transient inline spiking system has been completed, including cost estimates and parts list
Inline spiking system/procedure for evaluating virus clearance.
A well designed inline spiking system for viral clearance studies
Array of non-interacting tracer species
Experimental protocols and computational tools for quantitative evaluation of virus clearance
Malakian, A., Jung, S. Y., Afzal, M. A., Carbrello, C., Giglia, S., Johnson, M., Miller, C., Rayfield, W., Boenitz, D., Cetlin, D., & Zydney, A. L. (2022). Development of a transient inline spiking system for evaluating virus clearance in continuous bioprocessing-Proof of concept for virus filtration. Biotechnology and Bioengineering, 119(8), 2134-2141. https://doi.org/10.1002/bit.28119
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The Pennsylvania State University
Cygnus Technologies
Genentech, Inc.
Merck Sharp & Dohme LLC
MilliporeSigma/EMD Serono
