Thẩm định quy trình phát hiện Mycoplasma trong quá trình nuôi cấy các dòng tế bào tại Viện Kiểm nghiêm thuốc Trung ương bằng bộ kit MycoAlert™ PLUS.

Abstract

Validation of the MycoAlert™ PLUS kit for detecting Mycoplasma contamination in Vero 76 and L929 cell cultures was conducted at the National Institute of Drug Quality Control. The study assessed system suitability, specificity, and repeatability of the method, demonstrating its effectiveness in detecting Mycoplasma in these cell lines. Results confirmed the kit’s reliability and suitability for routine monitoring of cell cultures. These findings support the integration of the MycoAlert™ PLUS kit into quality control protocols, ensuring contamination-free cell culture processes.