Quantitative mass spectrometry is an analytical tool used for specific and sensitive identification and quantitation of biopharmaceutical products and impurities. Scientists at BioPharmaSpec have significant expertise in the method development for the quantitation of components in biopharmaceutical products.
Methodology and Instrumentation
Quantitative assessments of biopharmaceutical products and impurities include protein and/or carbohydrate chemistry to generate marker peptides, glycopeptides (or drug conjugated peptides from Antibody Drug Conjugates- ADCs).
BioPharmaSpec uses on line Liquid Chromatography with electrospray ionisation and tandem MS/MS analysis (LC/ES-MS/MS) to identify and quantify the marker peptides relative to synthetic heavy cold labelled reference peptides with the same sequence.
BioPharmaSpec can accurately quantify different components within your biopharmaceutical product including:
- Active ingredient (e.g. the monoclonal antibody)
- Impurities and contaminants
- Host Cell Proteins (HCPs)
BioPharmaSpec is also highly experienced in providing Drug Antibody Ratios (DARs) for ADCs in a variety of matrices to support PK studies and in vitro stability studies.