Effective sterility testing is a crucial component in the manufacturing of life-saving drugs and therapies, ensuring that ...

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, ...

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 ...

Emcure Pharmaceuticals has had its share of run-ins with the FDA in the past over the sterility of one of its Indian manufacturing plants. Now, it can notch one more black mark on its belt. The FDA ...