Novel Diagnostic Platforms for Sterility Testing of Cellular Therapies and Biopharmaceutical Products

在本财年，我们发表了第一项研究，以评估iLYM作为封闭系统的自动化替代沙堡葡糖琼脂培养的性能，以改进细胞和基因治疗无菌测试中真菌污染物的检测。这项研究对生物制药行业产生了重大影响，因为无菌测试的测试方法已经过时，设计用于无菌原料药，通常不适用于细胞和基因治疗产品。此外，我们发表了cGMP与临床微生物学实验室的并列比较，以努力教育参与人类细胞、组织以及细胞和基于组织的产品(HCT/Ps)的临床同事。我们还出版了几本关于细胞和基因治疗测试的微生物学指导和指南的书籍章节，并继续积极发表MALDI-TOF MS在临床真菌学中的应用。

During this fiscal year, we published the first study to evaluate the performance of iLYM media as a closed-system, automated alternative for Sabouraud Dextrose Agar culture for improved detection of fungal contaminants for cell and gene therapy sterility testing. This study impacts the biopharmaceutical industry significantly, as test methods for sterility testing are outdated, designed for sterile bulk pharmaceuticals, and are generally unsuitable for cell and gene therapy products. In addition, we published a side-by-side comparison of cGMP vs clinical microbiology labs in an effort to educate clinical colleagues participating in human cells, tissues, and cellular and tissue-based products (HCT/Ps). We have also published several book chapters for microbiological instruction and guidance for cell and gene therapy testing and continue to actively publish on MALDI-TOF MS applications for clinical mycology.