CDMO Services

AAV cGMP Manufacturing

With the explosive growing of gene therapy development, mass-production and packaging process of GMP grade rAAV in compliance with all applicable regulatory and standards are badly needed for IIT (PI initiated clinical trials), IND permit applications, Phases-I, -II, and -III clinical trials. Based on our own intellectual properties, from the upstream rAAV generation to the downstream isolation and purification technologies, PackGene provides mass-production services of GMP-compliant AAV, as well as GMP production line setting-up, processing and assay transfer, IND pharmacological documentation, etc. PackGene ensures AAV manufacturing services are in compliance with GMPs and all applicable regulatory and required standards for IIT and IND applications.

Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility （~2000 square meter） start to begin production in 2021. For more information, please contact us: bd@packgene.com

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

AAV Manufacturing Process

PackGene GMP-compliant services include AAV upstream production and downstream purification development, large-scale fermentation, material segregation, full traceability, document control, and a comprehensive range of quality control assays.

PackGene has developed core processing technology to greatly increase the single-batch AAV output and reduce the input cost, which brings to a lot of benefit or added value for cooperated customers.

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

AAV Manufacturing Facilities

PackGene AAV GMP facility was designated and built specifically for AAV vector manufacturing. We utilize bioreactors applying single-use technologies with expandable capacity in the future. Currently, our AAV GMP base is equipped with the world’s leading adhesion and suspension production system. The downstream production line, equipped with chromatography purification system and high-yield process, establishing a variety of process routes and optimization under GMP condition.

PackGene facility includes iCellis500 (~500m2 adhesion area), STR50/200/500T with the single-use technology that can flexibly conduct both GMP AAV upstream production by adherent and suspension culture.

Our advantages

Designed with QbD concept and optimization
Clean environment in accordance with C+A standards
Reaching the maximum AAV yield up to 1E+15GC-1E+17 GC/batch
Isolated vector producing line to completely avoid cross-contamination between different vectors
GMP-compliant pilot production cycle can be shortened to 1-2 months
Single-use technology and water supply to ensure batch cleaning verification

PackGene can provide cGMP AAV manufacturing for your project. Please provide your project details to get a quote or technical support from PackGene.

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