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  • Virus inactivation by protein denaturants used in affinity chromatography.

Virus inactivation by protein denaturants used in affinity chromatography.

Biologicals : journal of the International Association of Biological Standardization (2007-05-23)
Peter L Roberts, David Lloyd
ABSTRACT

Virus inactivation by a number of protein denaturants commonly used in gel affinity chromatography for protein elution and gel recycling has been investigated. The enveloped viruses Sindbis, herpes simplex-1 and vaccinia, and the non-enveloped virus polio-1 were effectively inactivated by 0.5 M sodium hydroxide, 6 M guanidinium thiocyanate, 8 M urea and 70% ethanol. However, pH 2.6, 3 M sodium thiocyanate, 6 M guanidinium chloride and 20% ethanol, while effectively inactivating the enveloped viruses, did not inactivate polio-1. These studies demonstrate that protein denaturants are generally effective for virus inactivation but with the limitation that only some may inactivate non-enveloped viruses. The use of protein denaturants, together with virus reduction steps in the manufacturing process should ensure that viral cross contamination between manufacturing batches of therapeutic biological products is prevented and the safety of the product ensured.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Sodium thiocyanate solution, BioUltra, 8 M in H2O
Sigma-Aldrich
Sodium thiocyanate, ≥99.99% trace metals basis
Sigma-Aldrich
Guanidine thiocyanate, BioUltra, for molecular biology, ≥99.0% (AT)
Sigma-Aldrich
Guanidine thiocyanate, ≥97% (titration)
Sigma-Aldrich
Guanidine thiocyanate solution, BioUltra, for molecular biology, ~6 M in H2O
Sigma-Aldrich
Guanidine thiocyanate, BioReagent, for molecular biology, ≥99%
Sigma-Aldrich
Guanidine thiocyanate, for molecular biology, ≥99%
Sigma-Aldrich
Sodium thiocyanate, ACS reagent, ≥98.0%
Sigma-Aldrich
Sodium thiocyanate, reagent grade, 98-102% (titration)
Sigma-Aldrich
Guanidine thiocyanate, for molecular biology, free-flowing, Redi-Dri, ≥99.0%