检测mAb工艺病毒污染
在当今的生物制品生产环境中，确认过程中间体不含可检出的外源病毒是一大难题。传统的体外和体内病毒检测通常需要数周才能完成，灵敏度有限，且往往只能识别特定污染物。此外，法规监管和伦理标准均要求减少使用动物模型，这也加剧了对生物安全检测新方法的迫切需求。为满足当今生物制品生产商的需求，业内开发出既可快速提供检测结果，又兼具灵敏度和特异性的分子检测技术。
生物制品生产正在向工艺强化和连续制造方向发展，加之现今开发的患者治疗方法更加多样化，这些都是推进生物安全性加速检测新方法的强大动力。
快速检测方法
检测病毒污染的分子检测技术通常可以在几天或一周内提供结果，而传统的大量收获批次放行检测方法通常则需要长达35天以上的时间。定向聚合酶链反应（PCR）和下一代测序（NGS）技术各有优点：PCR速度快，灵敏度高；NGS检测范围广。利用高度多重简并PCR方法的新型快速分子检测平台结合传统PCR和NGS的优点，可快速提供结果，检测范围覆盖5,000多种病毒变体，既加快了生物制品生产时间表，又提高了生产率。
细胞系特征鉴定
目前，法规监管机构要求进行广泛的细胞系特征鉴定，用来确认物种起源和历史以及细胞特征、稳定性和纯度。现在，这种水平上的细胞系分析有很多选择，更新的分子方法可更快地提供结果，使开发人员能加快生物制品进入临床的速度。
原料检测
原料是生物制品生产中的可变来源。 供应商的透明度、充分描述原料特征的全面检测，以及易于获取的文档记录，可确保原料适合特定用途。
检测新出现病毒
病毒污染是对所有生物制药生产过程的一个持续挑战，而新出现病毒的污染则是特别令人关注的问题。了解原料对这些病毒污染物的敏感性，以及传统和分子检测方法检测这些污染物的能力，是任何病毒安全战略的重要组成部分。
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Viral safety in bioprocessing relies on a framework of (1) preventing contamination, (2) detecting contamination, and (3) removing or inactivating viral contaminants.
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The safety of biologic medicines relies, in part, on a robust biosafety testing program applied across the biomanufacturing process to evaluate samples for the presence of adventitious agents.
- White Paper: Alternatives to In Vivo Assays for Biosafety Testing of Biologics Medicine Maker Article: A Biosafety Revolution
The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative methods such as PCR and NGS have emerged these in vivo tests have stubbornly remained a central part of testing. Here we examine the current in vivo methods and explore alternatives which can be employed today. We also propose that while the industry may be some years away from removing in vivo testing completely, a case can be made for removing animal use from well-characterized production systems such as CHO.
- White Paper: Avoid Surprises With Comprehensive Cell Line Characterization
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- eBook: Viral Safety: a Global Regulatory Perspective
Guidance for Raw Materials and Cell Lines, Preventing Contamination, Detecting Contamination, Viral Clearance Evaluation
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