Nina Moreno, Nelson Labs, explains how rapid sterility testing is reshaping pharmaceutical quality control—cutting release times, improving objectivity, and gaining regulatory momentum.

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 expansion currently defines the landscape as major players like Eli Lilly and Merck aggressively fund new manufacturing facilities. Concurrently, the industry embraces rapid technological ...

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 ...