-NovaBioassays

Elucidation of Structure

At Novabioassays, we provide a suite of analytical services to support the elucidation of structure characterization report for IND or BLA. Our services are listed as in the table.

Attribute	Assay	Purpose
Primary Structure	Mass analysis of intact mAb	To verify the molecular mass of the intact mAb
	Mass analysis of deglycosylated mAb	To verify the molecular mass of deglycosylated mAb
	Mass analysis of mass of reduced mAb	To verify the primary structure information of the light chain and the heavy chain
	Mass analysis of deglycosylated and reduced mAb	To verify the primary structure information of the light chain and the deglycosylated heavy chain
	Peptide-mapping of mAb and its deglycosylated form with multiple proteases	To verify the complete amino acid sequence
		To verify the N-terminal sequence of LC and HC
		To verify the C-terminal sequence of LC and HC
		To determine the identity and estimate the levels of post-translational modifications
N-glycan Profile	Peptide-mapping of mAb and its deglycosylated form with multiple proteases	To confirm the N-glycosylation site on HC
N-glycan Profile	Released N-glycan analysis from mAb by PNGase F using UPLC-FLD and LC-MS	To determine the identity of the glycoforms and their relative abundance
Higher Order Structure	Molar Mass and Size Analysis by size-exclusion chromatography coupled with multi-angle light scattering (SEC-MALS)	To estimate the molar mass of monomer
	Peptide-mapping of mAb for the reduced and non-reduced peptides	To confirm the sites of disulfide bond linkage
	Thiol assay	To determine free sulfhydryl (-SH) content
	Circular Dichroism (CD)	Compare protein secondary and tertiary structure of two lots
	Differential Scanning Calorimetry (DSC)	To determine transition temperatures, Tm, as a measure of thermal stability
Quality and Purity	SEC-HPLC, iCIEF, CE-SDS	To evaluate the quality and purity of mAb