CDMO Services

AAV Non-GMP Manufacturing

Packgene provide flexible and reliable AAV Non-GMP production services with both suspension and adherent upstream process and with purification by ultra-centrifugation and chromatography. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. Packgene’s non-GMP AAV product could be adapted to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.

Interested in our AAV services? Contact us for a free consultation or Request for a Quote.

AAV Non-GMP Product

√ Cell Bank Generation

√ Glass Bioreactor (1-10L) and 50L single use bioreactor for suspension culture；

√ Pall Nano 4m² adherent bioreactor（0.53-4 m²）

√ Ultra-centrifugation (optional) & AKTA Pure purification system

√ AAV process development

√ IND filing document preperation

√ CoA

Research grade vs. Non-GMP Grade

AAV	Research	Non-GMP
Transfection: Triple-Plasmid Transfection	√	√
Well traceability Cell-line	×	√
Adherent Cell Culture	√	√
Suspension Cell Culture	×	√
Purification with ultra-Centrifugation	√	√
Purification with chromatography	×	√
Manufacturing Summary Report	×	√
Testing Report	√	√
CoA	√	√

AAV Quality control (or customized based on specific process)

	Specification	Assay Methods
Identity	GOI Sequence	Sanger Sequence
Identity	AAV Capsid	SDS PAGE/MS
Purity	HPLC Purity	HPLC
	UV Purity	A260/A280
	%Empty capsids	AEX HPLC
		TEM
		AUC
	Aggregation	DLS
Potency & Content	Capsid Titer	ELISA
	Genome Titer	ddPCR
	Infectious Titer	TCID50
	Protein Expression	In Vitro assay
Impurity	Residual Host Cell DNA	qPCR
	Residual E1A	qPCR
	HCP Residue	ELISA
	BSA Residue	ELISA
	Residual Plasmid	ddPCR
	Residual Nuclease	ELISA
	Residual Iodixanol/CsCl	HPLC
	Residual Ligand	ELISA
Safety	Mycoplasma	qPCR/Mycoplasma culture /DNA staining
	rcAAV	Cell Assay+qPCR
	Bacterial endotoxin	LAL
	Sterility	Direct Inoculation Method/Membrane filtration
	Adventitious agent	Cell Culture
	Abnormal toxicity	Animal test
General Characterization	Appearance	Visual Inspection
	Content	Minimum Fill
	pH	pH Method
	Osmolality	Osmometers
	Particulate matter	Light Obscuration Particle Count test

Advantages of our AAV Non-GMP Production

Flexibility: Both Suspension and adherent culture process available and multiple scales of production available, which make it possible to complete your customized project with a time-saving manner.

Professional: Packgene has a professional AAV team with more than 10 years of experience.

Advanced equipment: Pall Nano bioreactor suitable for adherent culture while it’s the scale-down model icellis 500, which is available at packgene’s cGMP production services. Amber 250 ultra-scale down model used for high through-put process development available.