使用符合药品生产质量管理规范（GMP）生产的胶原酶和中性蛋白酶成功进行临床胰岛分离。
Successful clinical islet isolation using a GMP-manufactured collagenase and neutral protease.
作者信息
Szot Gregory L, Lee Michael R, Tavakol Mohammad M, Lang Jiena, Dekovic Florinna, Kerlan Robert K, Stock Peter G, Posselt Andrew M
机构信息
Department of Internal Medicine, Diabetes Center, University of California-San Francisco, San Francisco, CA, USA.
出版信息
Transplantation. 2009 Sep 27;88(6):753-6. doi: 10.1097/TP.0b013e3181b443ae.
Abstract
In 2007, the islet community was notified that the collagenase product most commonly used for human islet isolations contained bovine neural tissue contaminants. To minimize this potential hazard, we adapted our human islet processing procedure to use a GMP-manufactured, bovine neural tissue-free collagenase blend. Here, we describe the factors that we consider most important for achieving reproducible and clinically useable islet isolations using this product.
摘要
2007年，胰岛界收到通知，最常用于人类胰岛分离的胶原酶产品含有牛神经组织污染物。为了将这种潜在危害降至最低，我们调整了人类胰岛处理程序，改用一种由药品生产质量管理规范（GMP）生产的、不含牛神经组织的胶原酶混合物。在此，我们描述了使用该产品实现可重复且临床可用的胰岛分离时，我们认为最重要的因素。
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本文引用的文献
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