AAV Analytical services
Overview
NikeBio has established an advanced AAV analytical testing platform to fully evaluate the quality of AAV. We also provide a large number of advanced testing procedures, including toxicity testing, genomic titers (qPCR or ddPCR), endotoxin or mycoplasma levels, TEM empty shell rates, etc. We promise to provide multiple, robust test analysis protocols to meet your specific needs.
Analytical details
| Category | Services# | Test | Method | Turnaround Time(Calendar Day) | |
|---|---|---|---|---|---|
| Quantity | AS101 | AAV vector genome titration | dPCR | 5 | |
| Quantity | AS102 | AAV viral particals titration | ELISA | 5 | |
| Quantity | AS103 | Infectious titer | TCID50 | 21 | |
| Quantity | AS104 | Infectious titer | cell-based/dPCR | 21 | |
| Quantity | AS105 | Total protein | BCA | 3 | |
| ID | AS106 | AAV Genome ID | PCR/Sanger | 5 | |
| ID | AS107 | AAV capsid ID | SDS-PAGE | 5 | |
| Purity | AS108 | Empty/full | SEC-MALS | 5 | |
| Purity | AS109 | Empty/full | IEC-HPLC | 5 | |
| Purity | AS110 | Aggregation | DLS | 3 | |
| Purity | AS111 | Aggregation | SEC-HPLC | 5 | |
| Purity | AS112 | Vector capsid purity | SDS-PAGE | 5 | |
| Purity | AS113 | rHCP | ELISA | 5 | |
| Purity | AS114 | rHCD | qPCR/dPCR | 5 | |
| Purity | AS115 | Residual Plasmid DNA | qPCR/dPCR | 5 | |
| Purity | AS116 | E1A copy number | qPCR/dPCR | 5 | |
| Purity | AS117 | Residual Nuclease | ELISA | 5 | |
| Purity | AS118 | Residual transfection reagent | HPLC | 5 | |
| Purity | AS119 | Residual Tween20 | HPLC | 5 | |
| Purity | AS120 | Residual ligand | ELISA | 5 | |
| Safety | AS121 | rcAAV | cell-based-qPCR/dPCR | 21 | |
| Safety | AS122 | Mycoplasmas | qPCR | 5 | |
| Safety | AS123 | Endotoxin | LAL | 3 | |
| Safety | AS123 | Endotoxin | KCA | 3 | |
| General | AS124 | Osmolality | Osmometry | 3 | |
| Safety | AS128 | Subvisible Particles | USP | 3 | |
| Safety | AS130 | Content of excipient | HPLC | 5 | |
| Purity | AS201 | Plasmid ITR Integrity | dPCR | 5 | |
| Bioanalysis | AS301 | AAV ADA | ELISA | 7 | |
| Bioanalysis | AS302 | AAV neutralizing antibody | Cell-based/Gluc | 21 |