Ultra Rapid Microbial Detection in Cell and Gene Therapy Products

Introduction

The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. The Most Probable Number (MPN) was used to demonstrate that the LoD of the SCANRDI® CELL-BURST is not significantly different from the LoD of a traditional plate counting method on 10 compendial strains. To show the equivalency, we compared the proportion of positive results between both methods for all strains and all dilutions with a non-inferiority test of Farrington-Manning, with a 20% margin.