Patent 11549154 was granted and assigned to Regeneron Pharmaceuticals on January, 2023 by the United States Patent and Trademark Office.
Provided are compositions and methods useful to the determination of whether a microbial contaminant is present in a biological therapeutic production process. Specifically, an artificial positive amplification control plasmid and unique quantitative PCR detection probe are provided, which enables the rapid and real-time detection of a false positive result.