Detection and inactivation of porcine parvovirus in pharmaceutical ingredients

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To this date, many pharmaceutical products are manufactured from biological sources. When the products are derived from animal sources, it is essential to ensure the safety of the product by demonstrating the absence of viral contaminants.Cystic Fibrosis patients, in addition to suffering from respiratory problems, also suffer from severe digestive problems.  Nowadays, nutrition is considered the key factor to impact the longevity of CF patients.Key products used to enhance the food absorption of CF patients consist of mixtures of lipases, proteases and amylases from porcine pancreas extracts.  Because o f the porcine origin of those products, specific, robust and sensitive methods that can determine the presence of adventitious agents are necessary.This study aims at developing methods to assay for a common pathogen of pigs known as porcine parvovirus (PPV). Although this virus has never been shown to infect humans, it is prudent to ensure its absence from purified materials used in drug products derived from porcine tissues. This study further aims at removing or inactivating residual virus particles found in those pharmaceutical preparations.Additionally, we want to address the problem faced in the preparation of pharmaceuticals from biological extracts that these may be contaminated with viruses that are mutated in the manufacturing process.