LC-MS/MS of large molecules in a regulated bioanalytical environment – which acceptance criteria to apply?

Written by Knutsson M, Schmidt R, Timmerman P

“The current thinking from the EBF Topic Team is to start with a conservative approach when defining acceptance criteria and not to propose acceptance criteria that are still too demanding for the technology/analytical approach.”

Analysis of large molecules has become the talk of the day in the bioanalytical community. The increasing importance of peptides and proteins as therapeutic agents, together with the enormous possibilities offered by new MS-based technology, has opened a new world for the bioanalytical scientist. The European Bioanalysis Forum (EBF) has been following these new developments closely and have dedicated a Topic Team (TT) to discuss and share experiences on the bioanalysis of large molecules with LC–MS-based technologies. In this Editorial, the EBF wants to share their perspective on how to integrate LC–MS of peptides and proteins in regulated bioanalysis.

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