Analytical Development & Characterization

Amino Acid Sequence

• NH2-terminal sequencing and peptide mapping/MS.

Post-Translational Modifications / Degradation

• N-glycan profiling, peptide mapping/MS (glycosylation, glycation, phosphorylation, sulfation, deamidation and oxidation), ion exchange-HPLC (sialylation, sulfation and deamidation) and Ellman’s assay (unpaired Cys residues).

Purity

• SDS-PAGE, Western blot, size exclusion-HPLC, reversed phase-HPLC.

Aggregation/Structural Stability

• Near- and far-UV CD, intrinsic Trp fluorescence, structural melting curve, limited protease cleavage, multi-angle laser light scattering (MALLS), size exclusion-HPLC, SDS-PAGE.

Bioactivity

• In vitro binding by ELISA and Biacore.
   

Production Titer

• Protein A-HPLC for Abs and Fc-fusion proteins, product-specific ELISA and reversed phase-HPLC.