Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

To address these critical safety requirements, BETMAT Biotechnology LLC has released a specialized operational guide focused on Reliable Endotoxin Testing For Injectable Pharmaceuticals, a systematic ...

In the context of current good manufacturing practice (cGMP), a number of pharmaceutical manufacturers are incorporating Process Analytical Technologies (PAT), Quality by Design (QbD), or Process ...

The Trump administration is redoubling its efforts to phase out animal testing in drug development and seeking to develop new ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...