Qualitative and quantitative analysis GMP-compliant of intact and digested proteins by LC-MS/MS: a Case Study

Synopsis

Over the past 10 years, there has been a remarkable increase in the use of LC-MS/MS for the qualitative and quantitativedetermination of proteins. So that now this technique can be considered an established bio-analytical platform for thequantification of macro molecular drugs and biomarkers.
Moreover, with the extraordinary growth of therapeutic proteins in the pharmaceutical industry, the development of validatedmethods for the identification and quantification of bio-pharmaceuticals with orthogonal techniques is increasingly of scientificinterest.
In this scenario, what is fundamental for the current bio-pharmaceutical demand, is the development but especially thevalidation of LC-MS/MS methods in complex biological matrices in a regulated environment.
For this reason, our analytical goal has therefore been to develop and validate LC-MS/MS methods in a GMP environment forthe qualitative and quantitative analysis of bio-therapeutic products.