Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes. Cleaning validation for biologics ...

Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics. Within the bio/pharma industry, there is a ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...