Bacterial contamination may occur during the drug production process and impact both the drug substance, as well as the drug product quality. Bioassays used to ascertain bacterial contamination are time-consuming and costly.
Using ProteinMentor, bacterial contamination can be detected and quantified within the drug substance (DS), drug product (DP), cell culture and environmental samples. Significant time and resource savings are achieved with a vastly simplified workflow and final volume of only 2µL. ProteinMentor can be used as a validating technique to bioassays and provides a direct detection method that is rapid, reliable, and a cost-effective alternative.