Protein Characterization

We work with a wide range of protein types including monoclonal antibodies, antibody-drug conjugates (ADCs), recombinant proteins, fusion proteins, biosimilars, peptide hormones, enzyme therapeutics, and membrane proteins. Our team has experience with challenging proteins including highly glycosylated proteins, multi-subunit complexes, and proteins with complex post-translational modifications.

Sample requirements vary by analysis type. Generally, we request 50-200 μg of purified protein (>80% purity) for most characterizations. For challenging proteins or orthogonal testing, we may recommend additional material. We can work with lower sample amounts for preliminary studies—just contact us to discuss your specific requirements.

Yes. Our characterization services support regulatory submissions including IND, BLA, and marketing applications. We provide comprehensive documentation packages including method descriptions, raw data, analyzed results, and scientific interpretations. For GMP-regulated studies, we offer cGMP-compliant services with full audit trail documentation.

Absolutely. We specialize in biosimilar comparability studies using orthogonal analytical methods. Our package includes side-by-side characterization of your biosimilar candidate against the reference product, covering primary structure, higher-order structure, glycosylation, charge variants, aggregation, and functional assays.

Every characterization includes rigorous quality controls: instrument calibration verification, method-specific positive and negative controls, reference standard comparisons, and data reproducibility checks. For critical studies, we implement cross-validation between orthogonal methods.

We analyze all critical quality attributes (CQAs) including: identity and sequence verification, molecular weight and aggregates (SEC-MALS), higher-order structure (CD, FTIR), glycosylation profile, charge variant distribution (icIEF), thermal stability (DSC), and potency when required. Our approach ensures complete characterization aligned with ICH Q6B guidelines.

Yes. Our glycosylation characterization services include N-glycan and O-glycan profiling, monosaccharide composition analysis, sialic acid quantification, glycopeptide mapping, and site-specific glycan analysis. We use HPLC-FLD, LC-MS/MS, and exoglycosidase digestion for complete glycan characterization.