Analytical Method Development & Quality Control-Prophylatic/Therapeutic Vaccine-AAV / Vaccine / in vivo CAR-T CDMO

Our comprehensive service platform is supported by a highly skilled GMP quality control team with extensive expertise in method development, qualification/validation, and compliance testing, ensuring consistent product quality throughout the entire lifecycle. The table below presents the key release testing parameters.

Category	Quality Attibutes	Analytical Method
Identity	Identity	WB, SDS-PAGE
	Molecular weight	SDS-PAGE
	Isoelectric point	Isoelectric focusing (IEF)
Quantification	Protein concentration	BCA, UV
Potency	Biological activity	In vitro bioassay
Potency	Specific activity	Biological activity:Protein concentration
Purity	Purity	SDS-PAGE, CE-SDS, HPLC
Impurities	Process-related residuals	ELISA, HPLC
	Residual Sf9 host cell DNA	qPCR
	Residual baculovirus DNA	qPCR
	Residual Sf9 host cell proteins	ELISA
	Residual baculovirus proteins	ELISA
	Residual rhabdovirus contaminants	qPCR
Safety	Endotoxin	Gel clot assay, photometric assay
	Sterility	Cell culture
	Spiroplasma	qPCR
	Mycoplasma	Cell culture, qPCR
	Abnormal toxicity	Injection in mice/guinea pigs
Other Physicochemical Properties	Appearance	Visual inspection
	Visible particles	Optical inspection
	pH	Potentiometry
	...	...

Robust Quality Management System (QMS)

★★★
Regulatory Compliance	Aligned with ICH Q10 principles and global CMC regulations to meet GMP standards in China, the US, and the EU
Comprehensive Documentation	Structured to meet GMP requirements, covering six key areas: Quality, Materials, Manufacturing, 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
On-site Monitoring	Robust in-process control framework covering the 5Ms - Man, Machine, Material, Method, and Measurement - to ensure product quality
Data Integrity	Strict compliance with data integrity standards, fully aligned with ALCOA principles across manufacturing and testing
Validation & Control	Comprehensive qualification and validation processes to ensure product consistency and quality control

CDMO Service CRO Service TECHNOLOGY PLATFORM

Genevoyager Inc
3675 Market Street, Suite 200, Philadelphia, PA 19104
Tel: +1 (215) 205-6963
E-mail: hui.wang@genevoyager.com | globalbd@genevoyager.com

BrainVTA LLC
100 E Lancaster Ave, Suite LIMR R241, Wynnewood, PA 19096

Genevoyager (Wuhan) Co., Ltd.
No. 128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China
Tel: +86 17720522078 | +86 027-65023363
E-mail: marketing@genevoyager.com

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17720522078 027-62439686 marketing@genevoyager.com Wechat

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Analytical Method Development & Quality Control

Robust Quality Management System (QMS)

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