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从被内毒素污染中吸取的经验教训来源于细胞培养基中的补充剂

Koaki Uehara¹, Eriko Oshiro¹, Atsushi Ochiai¹

¹Social Medical Corporation Yuuaikai, Yuuai Medical Center, Advanced Medical Research Center, 50-5, Yone, Tomigusuku-shi, Okinawa 901-0224, Japan.

Regenerative therapy

|April 10, 2024

概括

基于细胞的产品中的内毒素污染被追溯到霍乱毒素试剂. 实施试剂测试或验证分析证书对于确保产品安全和质量至关重要.

科学领域:

微生物学微生物学
生物技术是生物技术.
细胞疗法细胞疗法

背景情况:

内毒素,来自格拉姆阴性细菌的火原体,需要在基于细胞的药品制造中严格控制.
在一项临床研究中,在自主口腔粘膜上皮细胞片的培养上浮体中检测到高的内毒素水平.

研究的目的:

为了调查临床研究中使用的自主口腔粘膜上皮细胞片中内毒素污染的来源.
为了确定在细胞培养过程中对内毒素污染负责的特定试剂.

主要方法:

测量了内毒素度在培养上浮物,未使用的培养介质和用于介质制备的试剂中.
样本包括上皮细胞片,培养基成分和霍乱毒素产品.

主要成果:

内毒素在未使用的培养基和上皮细胞表上浮体中都超过了可接受的极限.
培养基准备的试剂低于限值,除了霍乱毒素.
三批霍乱毒素产品显示了高度的内毒素,确定它是污染源.

结论:

霍乱毒素产品被确定为内毒素污染的主要来源.
试剂质量控制,包括内毒素测试或分析证书,对于防止细胞产品制造中的污染至关重要.
临床研究设施的积极措施对于确保基于细胞的药品安全至关重要.

关键词:

基于细胞的药物产品分析证书分析证书霍乱毒素是一种霍乱毒素.最后毒素 (Endotoxin) 是一种内毒素.层分层的上皮细胞

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