Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics

Mass spectrometry (MS) is a powerful analytical tool used in nearly all protein-based biologics license applications as a characterization method to assess a wide variety of protein attributes, including molecular mass, amino acid sequence, and critical chemical modifications

Source: FDA Center for Drug Evaluation and Research - What's New - October 28, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news