Need microbial contamination testing? We know the challenges.
DELAYED RESULTS
Obtaining results from bacterial endotoxin tests using horseshoe crab blood cells (Limulus amebocyte lysate, or LAL) and live rabbits takes at least 2-3 weeks, delaying your products’ arrival on the market.
INCOMPLETE SCOPE
Traditional tests only detect one kind of contamination—bacterial endotoxins—and can easily miss molds, yeasts, viruses and other contaminants, putting your customers’ health at risk. LAL testing is also known to yield false negatives, so when no contamination is detected, products must be sent for further costly and time-consuming tests using rabbits.
INACCURACY OF ANIMAL TESTING
The rabbit pyrogen test’s accuracy as a safety test for therapeutic products is currently questioned, especially for testing intramuscular or subcutaneous vaccine injections. Results can be inconsistent, since sensitivity varies from one rabbit to another depending on age, strain, sex, and environmental factors.
We can help, with Monocyte Activation Testing.
PROMPT, RELIABLE FINDINGS
Using an automated MAT (monocyte activation test) technology, PyroDex can provide you with a full report on test results in five days, or for expedited service, within 48 hours — enabling you to get your products to market faster.
COMPREHENSIVE PYROGEN DETECTION
PyroDex uses an FDA-approved technology that detects pyrogens (fever-causing substances) of all types — including endotoxins, and non-endotoxin pyrogens from Gram-positive bacteria, viruses, molds, and yeasts — so you can promote your products’ safety with complete assurance.
CONSISTENT, QUANTIFIABLE RESULTS
PyroDex’s MAT technology uses human-sourced monocytes to mimic the fever response to contaminants in vivo and is similar to the reaction when therapeutic products are administered to humans. The MAT’s quantitative readout provides statistical confidence of consistency among product batches.
“When the safety of medical drugs and devices is at stake, the MAT offers an unparalleled comprehensive view of the product’s safety status, by detecting any contaminant that causes fever, sepsis, multiple organ failure, or death, without regard to the contaminant’s specific molecular structure.”
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Contact us regarding your testing needs today!
