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AAV cGMP Manufacturing

With the explosive growing of gene therapy development, mass-production and packaging process of GMP grade rAAV in compliance with all applicable regulatory and standards are badly needed for IIT (PI initiated clinical trials), IND permit applications, Phases-I, -II, and -III clinical trials. Based on our own intellectual properties, from the upstream rAAV generation to the downstream isolation and purification technologies, PackGene provides mass-production services of GMP-compliant AAV, as well as GMP production line setting-up, processing and assay transfer, IND pharmacological documentation, etc. PackGene ensures AAV manufacturing services are in compliance with GMPs and all applicable regulatory and required standards for IIT and IND applications.

Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility (~2000 square meter) start to begin production in 2021. For more information, please contact us: bd@packgene.com

Interested in our AAV services?   Contact us for a free consultation or Request a quote.

AAV Manufacturing Process

PackGene GMP-compliant services include AAV upstream production and downstream purification development, large-scale fermentation, material segregation, full traceability, document control, and a comprehensive range of quality control assays.
PackGene has developed core processing technology to greatly increase the single-batch AAV output and reduce the input cost, which brings to a lot of benefit or added value for cooperated customers.
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

 

AAV Manufacturing Facilities

PackGene AAV GMP facility was designated and built specifically for AAV vector manufacturing. We utilize bioreactors applying single-use technologies with expandable capacity in the future. Currently, our AAV GMP base is equipped with the world’s leading adhesion and suspension production system. The downstream production line, equipped with chromatography purification system and high-yield process, establishing a variety of process routes and optimization under GMP condition.

PackGene facility includes iCellis500 (~500m2 adhesion area), STR50/200/500T with the single-use technology that can flexibly conduct both GMP AAV upstream production by adherent and suspension culture.

Our advantages

  • Designed with QbD concept and optimization
  • Clean environment in accordance with C+A standards
  • Reaching the maximum AAV yield up to 1E+15GC-1E+17 GC/batch
  • Isolated vector producing line to completely avoid cross-contamination between different vectors
  • GMP-compliant pilot production cycle can be shortened to 1-2 months
  • Single-use technology and water supply to ensure batch cleaning verification
PackGene can provide cGMP AAV manufacturing for your project. Please provide your project details to get a quote or technical support from PackGene.
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