Biosimilars

• Glycosyl quantitative composition
• Glycan linkage analysis
• Glycopeptide analysis
• Glycan sequencing
• Peptide mapping using enzyme digestion and mass spectrometry (MALDI-MS, LC-MS, and LC-NSI -MS/MS) including N– and C– terminal sequences
• Disulphide bridge mapping and chemical modifications by MS
• Free thiol determination
• Identification of Post Translational Modifications (PTMs) e.g. Deamidation, Acetylation, Phosphorylation, Sulfation
• 1D and 2D NMR for higher order structure determination

We offer method development, method validation and structural characterization study of many different sulfated products including, heparin, low-molecular-weight heparins (LMWHs), synthetic heparin analogues to evaluate active ingredient sameness of the generic and innovator products.

List of our services:

• Equivalence of physicochemical properties
• Equivalence of source material and mode of depolymerization
• Equivalence of building blocks, fragment mapping, sequence and linkage of oligosaccharide species

Evaluate active ingredient sameness of the generic and innovator products and for characterization of carbohydrate starting material and iron complexes:

• Glycosyl Composition Analysis
• Glycosyl Linkage Analysis
• Molecular Weight
• Mass Spectrometry
• NMR Characterization (proton, carbon, COSY, TOCSY, NOESY, HSQC, HMBC)
• Impurity Profile by HPLC

• Peptide mapping using enzyme digestion and mass spectrometry (MALDI-MS, LC-MS, and LC-NSI -MS/MS) including N– and C– terminal sequences
• Disulphide bridge mapping and chemical modifications by MS
• Identification of Post Translational Modifications (PTMs) e.g. Deamidation, Acetylation, Phosphorylation, Sulfation
• 1D and 2 D NMR for 3D Structure
• Identification and quantitation of Fatty acids

• Spin diffusion editing is used to filter out excipient signals for high-throughput comparison of macromolecular spectra
• NOESY is used for more in-depth analysis of higher-order structure