Table 1.

Panel of analytical methods used for the characterization of GMMA drug substances and drug products, thus formulated with Alhydrogel.

	Product Quality Attribute	Method	Reference
Drug substance	Purity	HPLC-SEC (fluorescence emission profile, A260–A280 nm)	[12]
	Size and aggregation status	SEC-MALS/DLS	[24]
	OAg identity and quantification	cELISA	[25]
	OAg quantification	HPAEC-PAD	[12,23,26]
	Total protein quantification	Micro BCA	-
	OAg length	HPLC-SEC on extracted OAg	[26]
	OAg O-acetylation content	1H NMR on extracted OAg	[26]
Drug product	OAg identity and quantification	FAcE	[25]
	Size distribution	Laser diffraction	-
	OAg and protein not adsorbed to Alhydrogel	SDS-PAGE silver staining	-