A bacterial endotoxin is a type of pyrogen (a fever-causing agent) and is found in the cell wall of Gram-negative bacteria. If certain amounts of endotoxin are introduced into the bloodstream or spinal fluid via a parenteral drug or medical device, fever, septic shock, organ failure, or death can occur. Due to the possibility of serious illness or death, all injectable pharmaceutical products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins to ensure patient safety. These products and devices are tested for endotoxins with a bacterial endotoxin test (BET).
SCANRDI is a rapid alternative technology for detecting microbial contaminants in filterable drug products. The method utilizes a viability reagent which labels living microbes captured by a filter membrane that does not retain the drug product. The “viability substrate” component of the labeling solution is transported into the microorganism through the cell membrane. Living cells cleave the non-fluorescent viability substrate by an enzymatic esterase reaction, releasing fluorescent molecules (free fluorochrome) within the cell. The cell membrane impermeable to the fluorochrome allows it to be concentrated within the cell and detected by the SCANRDI’s laser. Non-living cells are not metabolically active and/or without intact cell membranes are not labeled. These stained microbes are then detected by Laser Scanning Cytometry, and their presence is confirmed by a trained microbiologist using a fluorescence microscope with an automated stage. The whole process is completed within 3-4 hours.
Prompt Praxis Laboratories, LLC, founded in 2011, is a women-owned fully-integrated analytical and microbiological testing lab powered with the current information technology to facilitate rapid drug development.
Prompt Praxis Labs helps you in designing, developing, implementing and managing an effective, safe and secure Analytical Testing Program for a Pharma Product.
We offer Ready To Analyze® Test Methods for analyzing a product’s strength, quality, purity, potency, and identity. We also provide services for analytical characterization, bioanalytical services, method development and validation, as well as method transfer and assistance.