Nelson Labs, a Sotera Health company and leader in microbiological testing, has expanded its rapid microbiological methods (RMMs) for product-sterility testing at three laboratory sites in the U.S.
Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, ...
Robust sterility testing is essential to ensure the safety of cell therapies. However, traditional culture-based analysis takes several weeks to confirm a therapeutic’s microbial contamination, which ...
The 14-day turn around time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell ...
Traditional sterility testing methods for the presence of bacteria and fungi in T-cell cultures are time-consuming, taking from seven up to 14 days, while this novel method takes only up to 24 hours ...
Based on test, membrane filtration test is currently at the forefront of the global sterility testing market with over 45.88% revenue contribution. Based on product type, sterility testing kits takes ...
Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated ...
The "U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourced), By Test Type (Bacterial Endotoxin, Sterility), By End Use, By Sample, And Segment ...