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Filter preconditioning enables representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities
Endogenous and adventitious virus removal by size-exclusion membrane filtration is a critical dedicated step in an overall viral clearance strategy employed by biologics manufacturers as required by industry regulators. However, the addition of impurities from virus spike preparations used in valida...
Autores principales: | , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Portland Press Ltd.
2009
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2782314/ https://www.ncbi.nlm.nih.gov/pubmed/18844606 http://dx.doi.org/10.1042/BA20080133 |