Cat No. | Test | Method | Sample Requirement | Turnaround Time (Calendar Day) |
DT001 | AAV Genome Titration <ddPCR> | ddPCR | Custome primers/probe sequence and predicted titer range; Sample volume>10μl | 7 |
DT002 | AAV Capsid Titration | ELISA | Information of AAV serotype and sample matrix solution 2ml (with buffer info and pH); Sample volume>10μl | 7 |
DT003 | Infectious Titer <TCID50> | Serial Dilution and qPCR | Genome titer or predicted titer range; Sample volume>10μl | 21 |
DT004 | Purity Analysis <SDS-PAGE> | SDS-PAGE with Coomassie blue staining | Sample titer>1E+12vg/ml; Sample volume>10μl | 7 |
DT005 | Purity Analysis <CE-SDS> | CE-SDS | Sample titer> 1E+12vg/ml; Sample volume>30μl | 7 |
DT006 | Purity Analysis <AEC-HPLC> | AEC-HPLC | Sample titer> 1E+12vg/ml; Sample volume>50μl | 7 |
DT007 | Purity and Aggregation Analysis <SEC-HPLC> | SEC-HPLC | Sample titer> 1E+12vg/ml; Sample volume>50μl | 7 |
DT008 | AAV Capsid Peptide Mapping | HPLC-MS/MS | Genome titer>5E+12vg/ml; Sample volume>500μl | 21 |
DT009 | Capsid Protein Molecular Weight and Ratio Analysis | RP-HPLC-MS | Genome titer> 5E+12vg/ml; Sample volume>100μl | 21 |
DT010 | Residual Host Hek293 Cell DNA | qPCR | Genome titer | 7 |
DT011 | Residual Hek293 Host Cell DNA | qPCR | Genome titer | 7 |
DT012 | Residual plasmid DNA | ddPCR | Genome titer | 7 |
DT013 | Residual E1A | ddPCR | Genome titer | 7 |
DT014 | Residual Host Cell Protein | ELISA | Sample matrix solution 2ml (with buffer info and pH) | 7 |
DT015 | Residual BSA | ELISA | Sample matrix solution 2ml (with buffer info and pH) | 7 |
DT016 | Residual Nuclease | ELISA | Sample matrix solution 2ml (with buffer info and pH) | 7 |
DT017 | Residual Affinity Ligands | ELISA | Sample matrix solution 2ml (with buffer info and pH) | 7 |
DT018 | Residual PEI | HPLC | Sample matrix solution 2ml; Sample volume>200μl | 7 |
DT019 | Residual Tween20 | HPLC | Sample matrix solution 2ml; Sample volume>100μl | 7 |
DT020 | Residual Triton X100 | HPLC | Sample matrix solution 2ml; Sample volume>100μl | 7 |
DT021 | Residual Iodixanol | HPLC | Sample matrix solution 2ml; Sample volume>100μl | 7 |
DT022 | Residual Poloxamer 188 | HPLC | Sample matrix solution 2ml; Sample volume>100μl | 7 |
DT023 | Replication-Competent AAV (rcAAV) Analysis | Infection on Permissive Cells | Titer>1E+12vg/ml; Volume>50μl | 30 |
DT024 | AAV Genomic Integrity <CE> | CE-SDS | Titer>1E+12vg/ml; Volume>50μl | 7 |
DT025 | AAV Genomic Sequencing <TGS> | 3rd Generation Sequencing | >5E+12vg | 40 |
DV001 | Analytical Method Development and Validation | Genome titration <ddPCR> | Predicted titer range and primer sequences | 30 |
DV002 | Analytical Method Development and Validation | TCID50 | Determined genome titer or predicted genome titer range | 50 |
DV003 | Analytical Method Development and Validation | rcAAV Analysis | N/A | 50 |
DV004 | Analytical Method Development and Validation | Capsid Analysis (AUC) | 10ml per sample | 50 |
DV005 | Analytical Method Development and Validation | Capsid Analysis (AEC HPLC) | 5ml per sample | 30 |
DV006 | Analytical Method Development and Validation | AAV Gene Expression Level | Per Project Plan | Starting from 30 |
DV007 | Analytical Method Development and Validation | AAV Potency | Per Project Plan | Please Inquire |
TS001 | Analytical Method Development, Validation, and Release Testing Service (full suite) | Per Project Plan | Per Project Plan | 60 |
TS002 | AAV Release Testing Service | Per Project Plan | Per Project Plan | Please Inquire |
TS003 | AAV Stability Testing Service | Per Project Plan | Per Project Plan | Please Inquire |
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