Automated Quality Control of Biopharmaceutical N-/C-Terminal Sequences by Routine Top-Down Mass Spectrometry

摘要

MALDI analysis of intact monoclonal antibodies with 1,5-DAN as matrix can be used for terminal sequence/modification validation of both, heavy and light chains, allowing fast and simple antibody QC. Overall, the methods takes only a few minutes from sample preparation, spectrum acquisition and processing to the result in form of sequence annotation in the ISD spectrum. Dedicated TDS software allows a very fast and reliable spectrum interpretation. A PDF report provides documented results of the TDS analysis in standardized format.