Company secures $5M in funding to accelerate its rapid testing platformUSP<1223> Validation achieved, reinforcing 20-hour testing methodFaster test results replace the standard 14-day USP sterility ...

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 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 ...

Accelerate product release with Nelson Labs’ RapidCert™ BI sterility test—validated for precision, speed, and compliance with USP <1223> and ISO 11138 standards. Cut incubation time from 7 days to ...

WASHINGTON (CN) - The Food and Drug Administration has amended the sterility test requirements for biological products. The FDA states that the new regulations are meant to provide manufacturers of ...

Nelson Labs, a Sotera Health company and a specialist in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, now performs ...

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, ...

Seoul National University College of Engineering announced that a research team led by Professor Sunghoon Kwon from the Department of Electrical and Computer Engineering, in collaboration with ...

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.

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...