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AAV GMP-like Manufacturing

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 can be applied on preclinical studies, IIT, etc.

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AAV GMP-like Product

 √      50L to 500L single-use bioreactor for suspension culture
 √      Pall icellis 500 m2 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)
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

 

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