AAV Non-GMP Manufacturing

Packgene provide flexible and reliable AAV Non-GMP production services with both suspension and adherent upstream process and with purification by ultra-centrifugation and chromatography. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. Packgene’s non-GMP AAV product could be adapted to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.

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

AAV Non-GMP Product

 √     Cell Bank Generation
 √     Glass Bioreactor (1-10L) and 50L single use bioreactor for suspension culture;
 √      Pall Nano 4m2 adherent bioreactor0.53-4 m2
 √      Ultra-centrifugation (optional) & AKTA Pure purification system
 √      AAV process development
 √      IND filing document preperation
 √      CoA
Research grade vs. Non-GMP Grade

 

AAV Research Non-GMP
Transfection: Triple-Plasmid Transfection
Well traceability Cell-line ×
Adherent Cell Culture
Suspension Cell Culture ×
Purification with ultra-Centrifugation
Purification with chromatography ×
Manufacturing Summary Report ×
Testing Report
CoA
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

 

Advantages of our AAV Non-GMP Production

Flexibility: Both Suspension and adherent culture process available and multiple scales of production available, which make it possible to complete your customized project with a time-saving manner.

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.

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