Biopharmaceuticals can exhibit tremendous heterogeneity in terms of posttranslational modifications (PTMs) such as glycosylation, oxidation, deamidation, phosphorylation etc. and structural modifications. In addition to this, changes in upstream and downstream processes during recombinant production of biologics also influence structural heterogeneity. Therefore, comprehensive characterization of biologics is necessary to ensure safety and efficacy.
Services offered by the Biologics Characterization Facility are listed below:
- Antibody-Drug Conjugate (ADC) analysis
- Disulphide linkage analysis
- Host Cell Proteins (HCP) using Mass Spectrometry
- Intact Mass-Reduced/ Non-Reduced
- N-glycan Analysis
- Peptide mapping
- Post translation modification
- Peptide-Drug Impurity Profiling
- Peptide Quantification
- Sequence variance analysis
- Sialic Acid Quantitation
We are working towards making the Biologics Characterization Facility compliant to ISO standards.