Analytical Method Development and Quality Control-AAV CDMO Service-CDMO Service

Genevoyager is equipped with a one-stop gene therapy CDMO platform, alongsidean experienced GMP quality control teamwithexpertise inmethodology development, validation/verification, and testing toensure the high quality of our products.The routine quality release tests and methods are outlined below.

Category	Test Item	Test Method
Identification and structural analysis	DNA identification	Sanger sequencing, Next-generation sequencing (NGS), Third-generation sequencing (TGS)
Identification and structural analysis	Capsid protein identification	Western blot, SDS-PAGE, CE, LC-MS
Biological activity	Potency	In vitro cell-based biological activity, Animal studies
Content	Virus capsid titer	ELISA
	Genome titer	ddPCR, qPCR
	Infectious titer	TCID50
	VG:IU	Ratio of genome titer to infectioustiter
Purity	Total protein	microBCA
	Capsid protein purity	SDS-PAGE, CE
	Viral monomer purity	SEC-HPLC
	Empty capsid ratio	AUC, TEM, AEX-HPLC, SEC-MALS
	Particle size	DLS
Impurities	Residual Sf9 host cell DNA	qPCR
	Residual Sf9 host cell protein	ELISA
	Residualnuclease	ELISA
	Residualinfectious baculovirus	Plaque assay, TCID50
	Residualbaculovirus DNA	qPCR
	Residualrhabdovirus	qPCR
	Specific process-related residues (affinity ligand, Triton, Tween20, etc.)	ELISA, UV, HPLC
Safety	Replication-competent AAV (rcAAV)	Culturemethod+ qPCR
	Mycoplasma	qPCR, Culture method
	Spiroplasma	qPCR, Culture method
	Endotoxin	Gel electrophoresis, Spectrophotometry
	Sterility	Membrane filtration, Direct inoculation
	Abnormal toxicity	Injectionin mouse and guinea pig

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