目的:评价基于二氧化碳检测原理的BacT/ALERT 3D Dual-T快速微生物检测系统作为药典无菌检查法的替代用于创新生物制品的可行性。方法:以细胞制品作为应用对象,参考各国药典及国外指导原则,研究快速方法在专属性、检测限、非劣效性方面是否可替代药典方法。结果:评价结果表明快速方法在专属性和检测限参数上达到了药典方法性能相当,大部分情况下可比药典方法更快地报告阳性结果,快速方法对产品质量的决策不劣于药典方法,且在数据完整性方面具备优势。结论:在风险管理的前提下,经验证的快速方法可作为药典无菌检查的替代方法用于创新生物制品的快速放行。
Objective: To evaluate feasibility of the BacT/ALERT 3D Dual-T rapid microbial detection system based on carbon dioxide signal detection technology as an alternative to the pharmacopoeia sterility test for innovative biologics. Methods: Taking cell products as the application object and referring to pharmacopoeia and foreign guidelines, whether the pharmacopoeia method could be replaced with the rapid method in terms of specificity, LOD and non-inferiority. Results: The evaluation results show that the rapid method was equivalent to the pharmacopoeia method in terms of specificity and detection limit parameters; in most cases, it could report positive results faster than the pharmacopoeia method. The rapid method was not inferior to the compendial method in product quality decision-making, and had advantages in terms of data integrity. Conclusion: Under the premise of risk management, the proven rapid microbiological method can be used as an alternative method to pharmacopoeia sterility testing for rapid release of innovative biologics..
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