AAV One-stop Solution

Overview

AAV are the most widely used vectors for in vivo gene delivery due to their targeting specificity and exceptional safety when compared with other vectors. PackGene provides one-stop solution services for AAV IND application including cell banking, process development, analytical development, AAV manufacturing, and stability tests with filing document preparation. Our professional AAV teams and technological superiority will deliver your IND project with first-class quality and speed.

CDMO service

AAV One-stop Solution Timeline

PackGene offers triple transient transfection system that includes transfection with the GOI, helper, and Serotype plasmids and results in upstream AAV productivity capable of reaching 3-7 E11 vg/ml.

AAV Manufacturing Timeline

Detailed AAV One-stop Solution Workflow

AAV Manufacturing Workflow

Our Advantages

Productivity

Both Suspension and adherent culture process available. Four independent cGMP standard production lines with up to 500L single-batch production scale and overall productivity up to 2000L

Advanced equipment

Single-use technology applied one both upstream & downstream. Fill & Finish under VHP isolator. ddPCR for titer measurements, Analytical ultra-centrifugation for e/f ratio measurements available.

Quality

Our proprietary platforms, single use technologies, and segregated production facilities ensure the delivery of deliverables without cross-contamination

Flexibility

Multiple scales and grades of production make it possible for us to complete your project with high efficacy and reasonable price.

Professional

PackGene has a professional AAV production team with more than 10 years of experience.

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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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