BioPharmaSpec scientists were instrumental in the conception of the Quadrupole-Time of Flight (Q-TOF) geometry for mass spectrometry, a methodology which allows ultra-high sensitivity sequencing of biopharmaceuticals. We apply this ground-breaking expertise in our laboratories to provide you with accurate and reliable molecular weight data.
ICH Topic Q6b requests that “Molecular weight (or size) is determined using size exclusion chromatography, SDS-polyacrylamide gel electrophoresis (under reducing and non-reducing conditions), mass-spectrometry, and other appropriate techniques”
BioPharmaSpec performs on-line Liquid Chromatography with Electrospray-Mass Spectrometric detection (LC/ES-MS, Q-TOF) of your product. For monoclonal antibody based products, samples are usually analyzed:
- as received
- following reduction
- following de-N-glycosylation
- following reduction and de-N-glycosylation.