Analytical Method Development and Quality Control-AAV CDMO-AAV/Vaccine CDMO

Genevoyager provides end-to-end solutions for gene therapy,backed by an experienced GMP quality control team with expertise in method development, validation/verification, and testing to ensure the consistent,highest quality of our products. A summary of quality release tests and their corresponding methodologies is provided below:

Category	Test Item	Test Method
Identity and structural analysis	DNA identity	Sanger sequencing, next-generation sequencing (NGS), third-generation sequencing (TGS)
Identity and structural analysis	Capsid protein identity	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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★★★

✔ A comprehensive analytical method development & quality control platform covering the entireproduct lifecycle

✔ Development, transfer, validation, and verification of analytical methods

✔ Stringent release management to ensure high quality

✔ One-stop services for stability studies

✔ Robust quality management system, supporting IND/BLA for global partners

★★★
Regulatory Compliance	Aligned with ICH Q10 principles and global CMC regulations to meet GMP standards n China, the US,and the EU
Comprehensive Documentation	Structured to meet GMP requirements, covering six key areas: Quality, Materials, Manufactuing,Facilities &Equipment, Laboratories, and Packaging&Labeling
Tailored Quality Management	Science-based, regulation-driven, and product-focused-tailored to CDMO operations and adapted to different project stages
Data Integrity	Strict compliance with data integrity standards,fully aligned with ALCOA principles across manufacturing and testing
On-site Monitoring	Robust in-process control framework covering the 5Ms -Man,Machine,Material,Method,and Measurement-to ensure product quality
Validation & Control	Comprehensive qualification and validation processes to ensure product consistency and quality control

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Analytical Method Development and Quality Control

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