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1. 发明授权

US07504204B2 Detection of transmissible spongiform encephalopathy (TSE) protein employing a highly sensitive Western blot assay and chemiluminescent detection system 有权
标题翻译：使用高度敏感的蛋白质印迹测定和化学发光检测系统检测传染性海绵状脑病（TSE）蛋白
公开(公告)号：US07504204B2
公开(公告)日：2009-03-17
申请号：US10406182
申请日：2003-04-03
申请人： Steve R. Petteway , Douglas C. Lee , Robert W. Kozak
发明人： Steve R. Petteway , Douglas C. Lee , Robert W. Kozak
IPC分类号： C12Q1/70 , G01N33/53
CPC分类号： G01N33/6896 , G01N2800/2828
摘要： The invention provides a rapid, sensitive immunoassay capable of detecting and quantitating pathogenic protein to a level of 3 to 5 logs. The preferred immunoassay utilized is a chemiluminescent endpoint for a Western blot immunoassay. The invention has been successfully applied to track the clearance of pathogenic protein during production of proteins derived from plasma. It is particularly applicable and has been confirmed by bioassay to relate TSE infectivity to quantitative results on prion protein.
摘要翻译：本发明提供能够检测和定量病原性蛋白质至3至5个日志水平的快速，灵敏的免疫测定。所采用的优选免疫测定法是Western印迹免疫测定的化学发光终点。本发明已成功应用于跟踪源自血浆的蛋白质产生过程中病原蛋白的清除。特别适用，并通过生物测定证实TSE感染性与朊蛋白的定量结果相关。

2. 发明授权

US06605445B1 Rapid method of determining clearance of prion protein 有权
标题翻译：确定朊病毒蛋白清除率的快速方法
公开(公告)号：US06605445B1
公开(公告)日：2003-08-12
申请号：US09253800
申请日：1999-02-22
申请人： Steve R. Petteway , Douglas C. Lee , Robert W. Kozak
发明人： Steve R. Petteway , Douglas C. Lee , Robert W. Kozak
IPC分类号： G01N33543
CPC分类号： G01N33/6896 , G01N2800/2828
摘要： Transmissible spongiform encephalopathies (TSEs) are a class of fatal, neurodegenerative diseases found in many mammalian species. Human TSEs include kuru, Creutzfeldt-Jakob disease (CJD), and fatal familial insomnia. Non-human TSEs include sheep scrapie, bovine spongiform encephalopathy (BSE), feline spongiform encephalopathy, and chronic wasting diseases in elk and mule deer. These neurodegenerative diseases are caused by prions and display characteristic amyloid plaque deposition. The only known component of the infectious prion is an abnormal, disease-causing isoform of the prion protein (PrP), called PrP scrapie (PrPSc). During a post-translational process, PrPSc is formed from the normal, cellular PrP isoform (PrPC). The scrapie isoform is less soluble, more proteinase-resistant, and more susceptible to aggregation than the wildtype protein. The claimed invention is directed toward a rapid, specific, sensitive, and quantitative method for the detection of TSE clearance from a plasma product utilizing a chemiluminescent Western blot immunoassay. This immunoassay format can detect picogram concentrations of PrPRES (proteinase resistant PrP fragment) and is linear over a 3-5 log range. The invention is useful for tracking the clearance of PrPSc during plasma manufacturing processes.
摘要翻译：传染性海绵状脑病（TSEs）是一类在许多哺乳动物物种中发现的致命的神经变性疾病。人类TSE包括库鲁，克雅氏病（CJD）和致命的家族性失眠症。非人类TSE包括麋鹿和骡鹿中的羊瘙痒病，牛海绵状脑病（BSE），猫海绵状脑病和慢性消耗性疾病。这些神经退行性疾病是由朊病毒引起的，并显示特征淀粉样斑块沉积。传染性朊病毒的唯一已知成分是朊病毒蛋白（PrP）的异常，致病同种型，称为PrP瘙痒病（PrPcc）。在翻译过程中，PrPSc由正常的细胞PrP同种型（PrPC）形成。瘙痒病同种型比野生型蛋白质更易溶解，蛋白酶抗性更高，更易于聚集。所要求保护的发明涉及使用化学发光蛋白质印迹免疫测定从血浆产物检测TSE清除的快速，特异性，灵敏和定量的方法。这种免疫测定方法可以检测皮克浓度的PrPRES（蛋白酶抗性的PrP片段），并且在3-5对数范围内是线性的。本发明可用于跟踪等离子体制造过程中PrPSc的间隙。

3. 发明授权

US06437102B1 Method of separating prions from biological materials 有权
标题翻译：从生物材料中分离朊病毒的方法
公开(公告)号：US06437102B1
公开(公告)日：2002-08-20
申请号：US09638275
申请日：2000-08-14
申请人： Douglas C. Lee , Steve R. Petteway , Christopher J. Stenland
发明人： Douglas C. Lee , Steve R. Petteway , Christopher J. Stenland
IPC分类号： A23J100
CPC分类号： C07K1/30 , C07K14/47 , Y10S435/962 , Y10S435/975
摘要： Disclosed is a method for separating prions from biological materials. The method includes adding a polyalkylene glycol, such as polyethylene glycol, to a solution of the biological material such that a precipitate containing the prion is formed. This precipitate is then separated from the solution of biological material, thereby removing prions. Biological materials include biologically derived fluids, such as cerebrospinal fluid, biological samples, such as brain homogenates, blood plasma fractions, and aqueous solutions of recombinantly produced products. The disclosed method provides an effective process for the removal of these infectious materials from the biological materials, which may be further processed to provide the therapeutic compositions.
摘要翻译：公开了从生物材料中分离朊病毒的方法。该方法包括将聚亚烷基二醇例如聚乙二醇加入到生物材料的溶液中，使得形成含有朊病毒的沉淀物。然后将该沉淀物与生物材料的溶液分离，从而除去朊病毒。生物材料包括生物衍生的流体，如脑脊液，生物样品，如脑匀浆，血浆级分和重组产物的水溶液。所公开的方法提供了从生物材料中去除这些感染性物质的有效方法，其可进一步加工以提供治疗组合物。

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