
- 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 |
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 |

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.
Resources
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.
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