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Quality Control and Quality Assurance
AAV
uBriGene's one-stop gene therapy CDMO service platform has rigorous and professional QA and QC teams to meet the testing requirements of all GMP AAV projects. Some testing items and methods for GMP AAV are listed below.
QC Category | QC Category | QC Method | QC Standard |
|---|---|---|---|
Appearance | Appearance | Visual inspection | Clear, colorless liquid |
Visible Foreign Bodies | Visible Foreign Bodies | Clarity illuminator | No visible foreign particles, turbidity or precipitates |
Concentration | Genome titer | qPCR | 50% 150% of labelled amount |
Concentration | Physical titer | ELISA | As requested by client |
Biological Activity | Infection titer | TCID50 | VG/IU≤730 |
Biological Activity | Gene of interest expression level | Western blot | Completed by client |
Identity | Gene sequence | Sanger sequencing | Identical to original sequence |
Identity | Capsid protein | SDS-PAGE | VP1+VP2+VP3 value within requirements |
Purity | Capsid protein purity | SDS-PAGE | (VP1+VP2+VP3) percentage should be over 90.0%; other impurities ≤5.0% |
Purity | Host DNA residue | qPCR | <15 ng/dose |
Purity | Plasmid DNA residue | qPCR | <1.0x1010 Copies/ml |
Purity | Host protein residue | ELISA | <100 ng/ml |
Purity | Nucleic acid residue | ELISA | ≤20.00 ng/ml |
Purity | AVB affinity ligand residue | ELISA | ≤1.0 ng/1012 VG |
Purity | A260/A280 | Spectrophotometry | ≥1.20 |
Purity | Empty capsid rate | AUC | ≤30% |
Purity | Iodixanol residue | HPLC | ≤35 ppm |
Purity | Tween 20 residue | HPLC | ≤20 ppm |
Purity | Fecto-VIR residue | HPLC | ≤500 ppm |
Physical Properties | Particle size distribution range | Dynamic light scattering | Particle size 2040 nm; multimer content ≤5.0% |
Physical Properties | pH | pH meter | pH 6.87.8 |
Physical Properties | Osmolality | Freezing point depression | 270380 mOsmol/kg |
Physical Properties | Quantity filled | Concentration test | No less than labelled value |
Physical Properties | Insoluble particles | Absorption test | Each container has <6000 particles larger than 10 µm and <600 particles larger than 25 µm |
Safety | Replicable AAV | Cell culture and qPCR | 1 rcAAV/108 VG |
Safety | E1A transfer | Cell culture | No E1A gene detected |
Safety | Endotoxin | (LAL) Gel clot | 2 EU/dose |
Safety | Sterilization | Bacteria culture | No bacterial culture found |
Safety | Mycoplasma | qPCR | Negative |
Lentivirus
uBriGene's one-stop gene therapy CDMO service platform has rigorous and professional QA and QC teams to meet the testing requirements of all GMP plasmid projects. We have completed the methodological development and verification of more than ten GMP plasmid products. We also provide relevant data used for your IND application. Some testing items and methods for GMP plasmids are listed below.
QC Category | QC Method | QC Standard |
|---|---|---|
Identity | Sequencing | Same as original sequence |
Appearance | Visual inspection | Light yellow to dark yellow liquid |
Residual DNA | qPCR | ≤300 ng/ml |
Residual Plasmid | qPCR | ≤50 Copies/IU |
Residual HCP | ELISA | ≤25 µg/ml |
Benzonase Residue | ELISA | ≤20 ng/ml |
Foreign DNA Segment Size | Gel Electrophoresis | <500 bp |
Bovine Serum Albumin Residues | ELISA | <0.20 pg/IU |
Integration Units | qPCR | ≥1.0x108 IU/ml |
Lentivirus Titer (Total Number of Particles) | ELISA | ≥1.0x109 Lps/ml |
Lentivirus Transduction Titer | Immunofluorescence | ≥1.0x106 TU/ml |
pH Value | pH meter | 7.0-9.0 |
Endotoxin | Gel clot | <40 EU/ml |
Sterility Test | Cell culture | No bacterial culture found |
Mycoplasma Test | qPCR | Negative |
Replication Competent Lentivirus | PCR | Negative |
SV40 Gene Transfer | qPCR | <1.0x105 Copies/µl |
E1A Gene Transfer | qPCR | <1.0x105 Copies/µl |
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