Marius Marine, Fernandez Clothilde
Sanofi, 1541 Ave. Marcel Mérieux, 69280 Marcy l'Etoile, France.
Microorganisms. 2024 Apr 12;12(4):788. doi: 10.3390/microorganisms12040788.
Mycobacteria can be one of the main contaminants of biological products, and their presence can have serious consequences on patients' health. For this reason, the European Pharmacopoeia mandates the specific testing of biological products for mycobacteria, a critical regulatory requirement aimed at ensuring the safety of these products before they are released to the market. The current pharmacopeial reference, i.e., microbial culture method, cannot ensure an exhaustive detection of mycobacteria due to their growth characteristics. Additionally, the method is time consuming and requires a continuous supply of culture media, posing logistical challenges. Thus, to overcome these issues, pharmaceutical industries need to consider alternative non-microbiological techniques to detect these fastidious, slow-growing contaminating agents. This review provides an overview of alternative methods, which could be applied within a quality control environment for biological products and underlines their advantages and limitations. Nucleic acid amplification techniques or direct measurement of mycobacteria stand out as the most suitable alternatives for mycobacterial testing in biological products.
分枝杆菌可能是生物制品的主要污染物之一，其存在会对患者健康造成严重后果。因此，欧洲药典规定对生物制品进行分枝杆菌的特定检测，这是一项关键的监管要求，旨在确保这些产品在投放市场前的安全性。当前药典参考方法，即微生物培养法，由于分枝杆菌的生长特性，无法确保对其进行全面检测。此外，该方法耗时且需要持续供应培养基，带来了后勤方面的挑战。因此，为克服这些问题，制药行业需要考虑采用替代的非微生物技术来检测这些挑剔、生长缓慢的污染因子。本综述概述了可应用于生物制品质量控制环境的替代方法，并强调了它们的优缺点。核酸扩增技术或分枝杆菌的直接测量是生物制品中分枝杆菌检测最合适的替代方法。
