AAV GMP-like Manufacturing
- 50L to 500L single-use bioreactor for suspension culture
- Pall icellis 500m² adherent bed（66m²-500 m²）for adherent culture
- Ultra-centrifugation (optional) & AKTA Ready/Pilot purification system
- Quality Inspection
- Batch record, manufacturing summary report, CoA
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|
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|
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.
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
PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.