New article by scientists at Alphalyse on using mass spectrometry to measure a product-related impurity in a novel biologic:
https://link.springer.com/article/10.1007/s00726-021-03004-9
N๐จ๐ฏ๐๐ฅโ+โ๐๐ ๐๐ ๐ฆ๐จ๐๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง ๐ข๐ง ๐ซ๐ก๐๐-๐๐๐ ๐๐ฑ๐ฉ๐ซ๐๐ฌ๐ฌ๐๐ ๐ข๐ง ๐. ๐๐จ๐ฅ๐ข:
Authors: Magdalena Widgren Sandberg, Jakob Bunkenborg, Stine Thyssen, Martin Villadsen and Thomas Kofoed
The scientists found and identified a novel post-translational modification in fermentation batches of Granulocyte-macrophage colony-stimulating factor (GM-CSF) recombinantly expressed in E. coli.
The modification gave a mass shift ofโ+โ70 Da. Peptide mapping analysis demonstrated its location to the protein N-terminus and lysine side chains.
Full article (open access): http://ow.ly/N6Dd50G2UUH
This study shows the importance of good analytics to detect and monitor product-related impurities during biologics development.