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AAV Non-GMP Manufacturing

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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.

Interested in our AAV services? Please contact us for a free consultation or  submit a request for a quotation.
AAV Non-GMP Product

√     Cell Bank Generation
√     Glass Bioreactor (1-10L) and 50L single use bioreactor for suspension culture;
√     Pall Nano 4m² adherent bioreactor0.53-4 m²
√     Ultra-centrifugation (optional) & AKTA Pure purification system
√     AAV process development
√     IND filing document preperation
√     CoA

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:

  • Flexibility: Both suspension and adherent culture process are available at multiple scales of production.
  • 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.
  • Efficiency: PackGene’s experienced team, advanced equipment, and streamlined processes ensure that your project will be completed in a timely manner.