Gene therapy represents one of the fastest growing biotherapeutics worldwide, with AAV at the forefront. This rapid growth is constantly challenging CMC approaches, from manufacturing through release ...

In 2010 the United States Pharmacopeia (USP) began modernizing their monographs [1]. As a part of this effort, test methods for the quantification of potassium now include ion chromatography. Ion ...

The U.S. Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies and other drugs be tested on animals, saying in a news release that there ...

With more than 230,000 positive drug tests since 2020, how the trucking industry detects drivers’ drug use is an important topic. Currently, Department of Transportation drug testing relies entirely ...