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

Clinical Center

Investigators

Linked publications, trials & patents

Abstract

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 This study impacts the biopharmaceutical industry significantly, as test methods for sterility testing are outdated, designed for sterile bulk pharmaceuticals, and are generally unsuitable for cell and gene therapy products.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.