Evaluation of viral inactivation of pseudorabies virus, encephalomyocarditis virus, bovine viral diarrhea virus and porcine parvovirus in pancreatin of porcine origin

Pancreatin is a substance containing enzymes, principally amylase, lipase, and protease. It is obtained from bovine or porcine pancreas and used in the treatment of pancreatic endocrine insufficiency in humans. Regulations and safety concerns mandate viral clearance (virus removal or inactivation) i...

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Bibliographic Details
Published in:	Journal of virological methods Vol. 208; pp. 79 - 84
Main Authors:	Caruso, C., Gobbi, E., Biosa, T., Andra’, M., Cavallazzi, U., Masoero, L.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-11-2014
Subjects:	Animals Cattle Disinfection - methods DNA Viruses - isolation & purification DNA Viruses - physiology DNA Viruses - radiation effects Hot Temperature Pancreatin Porcine RNA Viruses - isolation & purification RNA Viruses - physiology RNA Viruses - radiation effects Swine Technology, Pharmaceutical - methods Temperature Time Factors Viral Load Viral Plaque Assay Viral safety Virus Inactivation Pancreatin Porcine Viral safety
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Summary:	Pancreatin is a substance containing enzymes, principally amylase, lipase, and protease. It is obtained from bovine or porcine pancreas and used in the treatment of pancreatic endocrine insufficiency in humans. Regulations and safety concerns mandate viral clearance (virus removal or inactivation) in biopharmaceuticals such as pancreatin. A virus validation study was performed to evaluate virus clearance achieved in the final step of drying under vacuum by testing a panel of four animal viruses: Pseudorabies virus (PRV), Encephalomyocarditis virus (EMCV), Bovine viral diarrhea virus (BVDV), and Porcine parvovirus (PPV). Because of the product's virucidal effect and high cytotoxicity, the starting material was diluted to a ratio of 0.67g of dried pancreatin resuspended in 13.5mL of cell culture medium followed by a 50-fold dilution in cell culture medium before spiking. After heating at 60±1°C for 5h, the samples were diluted about 5-fold in cell culture medium and titered by the plaque assay method. The virus reduction factor ranged from 5.59 (for PPV) to 7.07 (for EMCV) and no viral plaque was observed, indicating that the process step was effective in the reduction and removal of virus contamination. Though no virus contamination events in pancreatin have been reported to date, evaluation of the production process for its ability to inactivate and/or remove virus contamination, particularly from zoonotic viral agents such as hepatitis E virus and Norovirus considered emerging pathogens, is necessary to ensure the viral safety of animal-derived biopharmaceuticals.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0166-0934 1879-0984
DOI:	10.1016/j.jviromet.2014.07.032