Detection and inactivation of porcine parvovirus in pharmaceutical ingredients

到目前为止，许多药物产品都是从生物来源生产的。当产品来源于动物时，必须证明产品不含病毒污染物，以确保产品的安全性。囊性纤维化患者除了患有呼吸系统疾病外，还患有严重的消化系统疾病。 目前营养被认为是影响CF患者寿命的关键因素，用于增强CF患者食物吸收的关键产品包括来自猪胰腺提取物的脂肪酶、蛋白酶和淀粉酶的混合物。 本研究旨在建立猪细小病毒（PPV）的检测方法。尽管从未显示该病毒感染人类，但谨慎的做法是确保猪组织制剂中使用的纯化材料中不存在该病毒。本研究的目的还在于去除或灭活这些药物制剂中的残留病毒颗粒。此外，我们还希望解决从生物提取物制备药物时所面临的问题，即这些提取物可能被生产过程中突变的病毒污染。

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.