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 product could be adapted to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.
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
AAV Quality Control (or customized based on specific process)
|Identity||GOI Sequence||Sanger Sequence|
|AAV Capsid||SDS PAGE/MS|
|%Empty Capsids||AEX HPLC|
|Potency & Content||Capsid Titer||ELISA|
|Protein Expression||In Vitro assay|
|Impurity||Residual Host Cell DNA||qPCR|
|Safety||Mycoplasma||qPCR/Mycoplasma culture /DNA staining|
|Sterility||Direct Inoculation Method/Membrane filtration|
|Adventitious agent||Cell Culture|
|Abnormal toxicity||Animal test|
|General Characterization||Appearance||Visual Inspection|
|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.