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实施快速"实验室袋"NAT方法的路线图

Philip Breugelmans¹, Karen de Roy², Orm Nieuwenhuizen²

¹Janssen Pharmaceutica NV, a Johnson & Johnson company, Turnhoutseweg 30, 2340 Beerse, Belgium.

PDA journal of pharmaceutical science and technology

|August 29, 2025

概括

细胞产品必须进行菌质检测. 一种新的快速核酸测试 (NAT) 方法将测试时间从28天大幅缩短到2小时,提高了微生物控制的准确性和效率.

科学领域:

微生物学
生物技术
制药科学

背景情况:

对于细胞衍生产品,质体检测至关重要.
补充方法耗时 (28天TTR),复杂,主观.
需要更快,更可靠的菌质检测解决方案.

研究的目的:

描述BioFire® Filmarray®技术用于质体检测的实施路线图.
详细说明基于mAb的产品的验证和监管提交过程.
分享J&J在实施这一新NAT方法方面的经验.

主要方法:

使用BioFire®Filmarray®技术,一个封闭的"实验室在一个袋子"NAT系统.
进行了可行性研究,验证和监管提交.
实施了一项全面的风险评估方法的引入.

主要成果:

达到了大约2小时的TTR.
证明易于使用,减少手工工作,提高数据完整性.
获得FDA和EMA对生物制药产品测试的监管批准.

结论:

生物Fire® Filmarray® 技术提供了一个快速,自动化和可靠的替代品.
成功实施和监管部门的批准为更广泛的采用铺平了道路.
这项技术可以增强制药行业的微生物控制策略.

关键词:

替代性和快速微生物学方法可比性方法验证质菌进行PCR 简化微生物检测适用性测试

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