AAV GMP-like Manufacturing

Overview

GMP-like is a faster and more cost-effective alternative to cGMP production, which can be produced in accordance with standard or customizable specifications. GMP-Source AAV are suitable for preclinical studies and PI initiated clinical trials (IIT).

CDMO service

AAV GMP-like Product:

  • 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

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

Contact Us

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5. GMP AAV Quote Request
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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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