Hello Scientists,

I am wondering whether it is feasible to develop a LC-MS/MS method to detect and quantify a big protein at ~50kd by LC-MS/MS? Even after an enzymatic cleavage, will we be able to quantify this protein present in one of our drug subtance which is at much higher concentration than the anlyte (protein)? . Will regulatory agencies accept this kind of LC/MS-MS methods for clearance studies?

Thanks in advance.

Mike S.