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成品细胞产品中内毒素的测定。

The determination of endotoxin in the finished cellular product.

机构信息

BioWhittaker Inc., Walkersville, Maryland, USA.

出版信息

Cytotherapy. 1999;1(5):423-8.

Abstract

BACKGROUND

With the advancement of genetics and hematopoiesis resulting in therapeutic applications, a growing focus has developed on the quality assessment of biological products generated for various cellular therapies. Endotoxin is a critical measure for the presence of Gram-negative bacteria, known to cause endotoxemia. Cellular products are currently regulated as medical devices. Each location engaged in clinical protocols is responsible for establishing a quality assurance program.

METHODS

In this study, endotoxin levels were assayed using both the gel-clot and kinetic chromogenic Limulus amebocyte lysate (LAL) assays on 33 patients' cellular products, produced in clinical laboratory settings as part of a clinical trial or approved protocol. These patient samples include tumor infiltrating lymphocytes (HSVtk). We sought to identify the more reliable and informative method for the determination of endotoxin levels in a variety of cellular products, to meet the growing demand for standardization of product quality assessment. Comparison of the most sensitive gel-clot LAL test (0.03 EU/mL), with the kinetic chromogenic LAL test, with a lysate sensitivity of 0.005 EU/mL, found many advantages of the more sensitive method.

RESULTS

The kinetic chromogenic LAL test, which has the greatest sensitivity, increased the percentage of samples with valid spike recoveries compared with the gel-clot LAL test from 65% to 70% at a 1:10 sample dilution; and from 81% to 88% at a 1:100 sample dilution. Ata sample dilution of 1:50 the kinetic chromogenic LAL test provided valid spike recoveries on 81% of all samples tested.

DISCUSSION

In the interest of providing the highest quality and safety in the finished cellular product, the determination of endotoxin by the kinetic chromogenic LAL test is a rapid, effective, easy-to-use method to detect the presence of Gram-negative bacterial contamination.

摘要

背景

随着遗传学和造血学的发展带来了治疗应用,人们越来越关注各种细胞疗法产生的生物产品的质量评估。内毒素是革兰氏阴性菌存在的重要衡量标准,已知其会引起内毒素血症。细胞产品目前作为医疗器械进行监管。参与临床方案的每个地点都负责建立质量保证计划。

方法

在这项研究中,使用凝胶凝固和动态显色鲎阿米巴细胞裂解物(LAL)测定法对 33 名患者的细胞产品进行了内毒素水平检测,这些细胞产品是在临床实验室环境中作为临床试验或批准方案的一部分生产的。这些患者样本包括肿瘤浸润淋巴细胞(HSVtk)。我们旨在确定更可靠和信息丰富的方法来确定各种细胞产品中的内毒素水平,以满足产品质量评估标准化的日益增长的需求。比较最敏感的凝胶凝固 LAL 测试(0.03 EU/mL)和动态显色 LAL 测试(裂解物灵敏度为 0.005 EU/mL),发现更敏感方法具有许多优势。

结果

与凝胶凝固 LAL 测试相比,具有最大灵敏度的动态显色 LAL 测试将 1:10 样品稀释时有效加标回收率的样品百分比从 65%增加到 70%;在 1:100 样品稀释时从 81%增加到 88%。在 1:50 的样品稀释度下,动态显色 LAL 测试对所有测试样本的 81%提供了有效的加标回收率。

讨论

为了在最终细胞产品中提供最高的质量和安全性,通过动态显色 LAL 测试测定内毒素是一种快速、有效、易于使用的方法,可以检测革兰氏阴性菌污染的存在。

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