AAV Non-GMP Manufacturing


PackGene provides 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 products are suitable for early research projects, in vivo animal studies, and preclinical studies including pharmacodynamics and toxicology studies.
CDMO service

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)
  • CoA
  • Ultra-centrifugation (optional) & AKTA Pure purification system
  • AAV process development
  • IND filing document preparation

AAV Quality Control (or customized based on specific process)

Specification Assay Methods
Identity GOI Sequence Sanger Sequence



UV Purity A260/A280
%Empty Capsids AEX HPLC
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
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


Both suspension and adherent culture process are available at multiple scales of production.


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.


PackGene’s experienced team, advanced equipment, and streamlined processes ensure that your project will be completed in a timely manner.

Contact Us

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5. GMP AAV Quote Request
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What is the source of PackGene cell bank?

PackGene’s h293 cell bank is officially authorized for commercial use.

What is the AAV output for a single batch fermentation?

PackGene offers single batch fermentation at several volumes, including: 2L, 7L, 25L, 50L, and 200L. AAV yields for each of these production volumes varies across AAV serotypes. As an example, AAV9 is a medium to high-yielding serotype, and expected yields for AAV9 are as follows:

Expected yield for AAV9
Volume Yield
2L 1E+14GC
50L 1E+16GC
100L 2E+16GC

What method is used to determine the empty shell rate for AAV samples?

Viral empty shell rate can be determined using several techniques including anion chromatography HPLC, Analytical Ultracentrifugation (AUC), Transmission Electron Microscopy (TEM), CyroTEM, or VG Titer/Capsid titer. AUC, TEM and CyroTEM are typically not suitable for quantitative quality control determinations and thus PackGene’s standard method for empty shell rate determination is anion chromatography HPLC. PackGene can provide additional CyroTEM and AUC analytical services to serve as a secondary verification of the results derived from anion chromatography HPLC.

How are GC/ml and vg/ml related to one another, and how does PackGene determine GC/ml for AAV products?

The terms genome copies per ml (GC/ml) and viral genomes per ml (vg/ml) are interchangeable and equal in most cases. At PackGene we may test GC by both qPCR and ddPCR. Testing by qPCR involves the use of a calibration standard while ddPCR may use optional reference products. Measurements by qPCR are more likely to be influenced by inter-lab and inter-operator variables, and ddPCR generally shows lower %RSD precision. Typically, GC is determined by qPCR during process exploration phase and for intermediate products while the GC of final products is more often determined by ddPCR.

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way


AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies


Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.