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.
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
AAV Quality Control (or customized based on specific process)
| Specification | Assay Methods | |
| Identity | GOI Sequence | Sanger Sequence |
| 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 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.
