GLYCOSOL 100

Spectrophotometric thermodynamic intrinsic solubilization kinetics analysis of glycosylation profiles of biological ingredients

Qualitative and quantitative ingredient screening during analytical and toxicological development prior to selecting the optimal glycosylated protein or ingredient for final development meeting target requirements
Anti-counterfeiting ingredient profiling including quantitative ingredient interaction potential profiling
Stability testing and QC – lot-to-lot consistency testing – Validating stability of glycosylated proteins
Complementary analytical tool for in silico glycoprotein engineering
Optimization and planning of manufacturing processes involving combination ingredients consisting of peptide fusion products

References:

Brinkmann U, Kontermann RE
The making of bispecific antibodies
MABS 2017; (9) 2: 182 – 212 (Eds. Taylor & Francis)
FDA Center For Biologics Evaluation and Research (CBER)
Considerations in Demonstrating Interchangeability With a Reference Product
Guidance for Industry January 12, 2017