Rahul Tevatia, PhD;¹ Jyoti Jha, PhD;¹ Philip Junker Andersen, MSc;² Vasilis Perros, MSc;² Soren Busch, MSc;³ Quinn Osgood, BSE;¹ Nilay
Chakraborty, PhD, MBA¹
Rapid microbiological methods (RMMs) offer numerous advantages over traditional culture-based testing; however, their adoption in pharmaceutical quality control is frequently delayed by the complexity and variability of method validation. A critical bottleneck is the reliable preparation of precisely quantified microbial inocula. Here, we demonstrate how MicroQuant™ quantitative reference microorganisms address this challenge. Across a panel of MicroQuant™ strains representing four compendial-relevant organisms, consistent inoculum control was observed throughout the RMM validation workflow. When integrated with the μCount3D™ (BioSense Solutions), an automated microbial cell counting system, and the IntuGrow system (IntuBio), a rapid growth-based colony forming units (CFU) detection platform, MicroQuant™ controls exhibited reproducible growth kinetics and quantitative agreement with the compendial plate-count method. These results demonstrate that MicroQuant™ controls support faster, more confident RMM validation in alignment with the United States Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur.).
