◆ Structure characterization 

Primary structure, high-order structure, mass spectrometry (intact/reduced/sub-unit/desugarization), composition of amino acid, N/C terminal amino acid sequences or full sequence analysis, enzymatic hydrolytic peptide map (for antibodies, CDR identification is required), peptide segment coverage, peptide mass fingerprint, and free sulfhydryl; 

Glycosylation modification (mainly N-glycosylation modification): including modification site, sugar chains structure, glycoform, sialic acid content, etc.; 

Other post-translation modification: N-terminal/C-terminal heterogeneity, oxidation, deamidization, pyroglutamic acid cyclization, aspartate isomerization, saccharification, etc.; 

◆ Activity analysis 

Fab activity: proliferation inhibition method, neutralization method, reporter gene method, and other in vitro cellular biological activity detection;

Fc activity: ADCC, CDC and ADCP testing, etc;

◆ Physical and chemical analysis:

Physical and chemical analysis of the preparation: appearance, pH, osmolarity, color and clarity. 

Purity analysis: reduced/non-reduced CE purity, CZE charge heterogeneity, iCIEF charge heterogeneity;

Content analysis: protein content analysis, CE-LIF glycoside content analysis;

Product identification: ultraviolet spectrum, infrared spectrum, and fluorescence spectrum, etc.; 

◆ Process residues analysis: residue analysis of additive during process; 

◆ Safety: microbial limit, sterility test, mycoplasma test, etc.