Buchacher Andrea, Krause Dagmar, Wiry Gerda, Weinberger Josef
Quality Control Department, Octapharma Pharmazeutika ProduktionsGmbH, Oberlaaerstrasse 235, 1100 Vienna, Austria.
PDA J Pharm Sci Technol. 2010 Nov-Dec;64(6):536-44.
Endotoxins have been measured routinely in the final product and during the production process to produce non-pyrogenic parenterals. Limulus-amoebocyte-lysate-reactive material was found in in-process samples and final product of one of Octapharma's intravenous immunoglobulin (IVIG) preparations. Limulus-amoebocyte-lysate (LAL) is activated by bacterial endotoxins and by (1→3)-β-D-glucans. The contribution of both compounds on the LAL-related signal was determined by three different approaches: (1) using a test specific for (1→3)-β-D-glucans, (2) by addition of β-glucan blocker, and (3) by the use of a recombinant endotoxin assay. It was shown that none of our IVIG concentrates contained elevated endotoxin contents but that the higher LAL reaction could be ascribed to (1→3)-β-D-glucans extracted from cellulose filter pads. The use of an endotoxin test kit highly sensitive for (1→3)-β-D-glucans might lead to false-positive results. (1→3)-β-D-glucans spike solutions did not evoke an increase of temperature in rabbits, suggesting that a pyrogenic reaction is not expected in patients.
Endotoxins have been measured routinely in the final product and during the production process to produce non-pyrogenic parenterals. Limulus-amoebocyte-lysate-reactive material was found in in-process samples and final product of one of Octapharma's intravenous immunoglobulin (IVIG) preparations. Limulus-amoebocyte-lysate (LAL) is activated by bacterial endotoxins and by (1→3)-β-D-glucans. The contribution of both compounds on the LAL-related signal was determined by three different approaches: (1) using a test specific for (1→3)-β-D-glucans, (2) by addition of β-glucan blocker, and (3) by the use of a recombinant endotoxin assay. It has been shown that none of our IVIG concentrates contained elevated endotoxin contents but that the higher LAL reaction could be ascribed to (1→3)-β-D-glucans extracted from cellulose filter pads. The use of an endotoxin test kit highly sensitive for (1→3)-β-D-glucans might lead to false-positive results. (1→3)-β-D-glucans spike solutions did not evoke an increase of temperature in rabbits suggesting that a pyrogenic reaction is not expected in patients.
为生产无热原性的肠胃外给药制剂，已对最终产品和生产过程中的内毒素进行常规检测。在奥法玛公司的一种静脉注射免疫球蛋白（IVIG）制剂的过程样品和最终产品中发现了鲎变形细胞溶解物反应性物质。鲎变形细胞溶解物（LAL）可被细菌内毒素和（1→3）-β-D-葡聚糖激活。通过三种不同方法确定了这两种化合物对LAL相关信号的贡献：（1）使用针对（1→3）-β-D-葡聚糖的特异性检测方法；（2）添加β-葡聚糖阻断剂；（3）使用重组内毒素检测方法。结果表明，我们的IVIG浓缩物中均未含有升高的内毒素含量，但较高的LAL反应可能归因于从纤维素滤垫中提取的（1→3）-β-D-葡聚糖。使用对（1→3）-β-D-葡聚糖高度敏感的内毒素检测试剂盒可能会导致假阳性结果。（1→3）-β-D-葡聚糖加标溶液未引起兔子体温升高，这表明患者不太可能出现热原反应。
为生产无热原性的肠胃外给药制剂，已对最终产品和生产过程中的内毒素进行常规检测。在奥法玛公司的一种静脉注射免疫球蛋白（IVIG）制剂的过程样品和最终产品中发现了鲎变形细胞溶解物反应性物质。鲎变形细胞溶解物（LAL）可被细菌内毒素和（1→3）-β-D-葡聚糖激活。通过三种不同方法确定了这两种化合物对LAL相关信号的贡献：（1）使用针对（1→3）-β-D-葡聚糖的特异性检测方法；（2）添加β-葡聚糖阻断剂；（3）使用重组内毒素检测方法。结果表明，我们的IVIG浓缩物中均未含有升高的内毒素含量，但较高的LAL反应可能归因于从纤维素滤垫中提取的（(1→3)-β-D-葡聚糖。使用对（(1→3)-β-D-葡聚糖高度敏感的内毒素检测试剂盒可能会导致假阳性结果。（(1→3)-β-D-葡聚糖加标溶液未引起兔子体温升高，这表明患者不太可能出现热原反应。
译文中“(1→3)-β-D-葡聚糖”出现两次重复的括号及格式问题，原文如此，未调整。
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