Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

A Standard Test Method is a conclusive procedure that yields a test result. So as to achieve accurate and relevant test results, a standard test method is definite, unambiguous, and experimentally ...

The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a ...