An application of mass spectrometry for quality control of biologicals: Highly sensitive profiling of plasma residuals in human plasma-derived immunoglobulin
MS with relative quantitation is used to profile plasma residual proteins in immunoglobulin. Sample pre-fractionation is mandatory to access residual proteins. FXIa spiked at 1 ng/mg is confidently identified. Each tested immunoglobulin product has its own plasma residual proteins profile. TEE-positive batch is differentiated by distinct profile, including high abundance of FXIa.