Curr Opin Biotechnol 2021 Sep 8;71:206-215. Epub 2021 Sep 8.
Attribute Sciences, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address:
Rapid technological advances have significantly improved the capability, versatility, and robustness of mass spectrometers which has led to them playing a central role in the development, characterization, and regulatory filings of biopharmaceuticals. Their application spans the entire continuum of drug development, starting with discovery research through product development, characterization, and marketing authorization and continues well into product life cycle management. The scope of application extends beyond traditional protein characterization and includes elements like clone selection, cell culture physiology and bioprocess optimization, investigation support, and process analytical technology. Read More