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 ...

Bioburden testing serves a variety of purposes, and the relevance of the data can range from relatively insignificant to extremely critical. Bioburden tests can be used for general tracking or ...

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 ...