Our comprehensive testing services cover a wide range of functional platforms, including physicochemical, characterization, molecular, microbiology, biochemical, cel functional, and FACS analysis. We offer over 300 established in-house platform methods to cater to diverse testing needs.
With ready-to-use quality control testing strategies for a broad range of CGT products, we help maximize the success of both R&D and commercialization efforts
Porton Advanced’s Plasmid product test list
| Attribute | Testing | Method | Sample Requirement | Testing Period | Note |
| General | Appearance | Visual inspection | Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required | 3-5 business days | The testing period does not include the transportation time. |
| pH (Ph.) | Potentiometric method | ＞500μL | 3-5 business days | ||
| Content | Concentration (A260) | UV spectrophotometry | ＞300μL | 3-5 business days | |
| Purity | A260/A280 ratio | UV spectrophotometry | ＞100μL | 3-5 business days | |
| Plasmid homogeneity | HPLC | ＞200μL | 3-5 business days | ||
| Plasmid homogeneity | AGE | > 20 μL | 3-5 business days | ||
| Plasmid supercoil | HPLC-SAX | ＞200μL | 3-5 business days | ||
| Plasmid supercoil | CGE | ＞200μL | 3-5 business days | ||
| Identity | Restriction digest | AGE | > 40 μL | 3-5 business days | |
| Impurity | Residual E.coli HCP | ELISA | Sample volume> 60 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | |
| Residual antibiotic-1 (Kanamycin) | ELISA | Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual antibiotic-2 (Gentamicin) | ELISA | Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual E.coli gDNA | qPCR | > 20 μL | 3-5 business days | ||
| Residual E.coli RNA | AGE | > 40 μL | 3-5 business days | ||
| qPCR | > 40 μL | 3-5 business days | |||
| HPLC | 200μL | 3-5 business days | |||
| Residual total Protein-1 | BCA | Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual total Protein-2 | Micro BCA | Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual total Protein-3 | Nano Orange | Sample volume> 30 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Safety | Endotoxin-1 (Ph.) | Gel-clot technique | ＞200μL | 5-7 business days | |
| Endotoxin-2 (Ph.) | Photometric technique | ＞200μL | 5-7 business days | ||
| Sterility-1 (Ph.) | Membrane filtration | ＞4mL | 14-16 business days | ||
| Sterility-2 (Ph.) | Direct inoculation | ＞4mL | 14-16 business days | ||
| Sterility-3 (Rapid test) | Rapid sterility test | ＞4mL | 5-7 business days |
Porton Advanced’s AAV product test list
| Attribute | Testing | Method | Sample Requirement | Testing Period | Note |
| Content | Vector genome titer-1 (ITR) | qPCR | Sample volume> 25 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | The testing period does not include the transportation time. |
| Vector genome titer-2 (ITR) | ddPCR | Sample volume> 25 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | ||
| Vector genome titer-3 (GOI) | qPCR | Sample volume> 25 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | ||
| Vector genome titer-4 (GOI) | ddPCR | Sample volume> 25 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | ||
| AAV 2/5/8/9 Capsid protein titer | ELISA | Sample volume> 20 µl Information of AAV serotype and sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Potency | Infectious titer | TCID50+qPCR | Sample volume>100μL Genome titer or predicted titer range | 9-11 business days | |
| Target gene expression | cell+WB/ELISA | Sample volume>100μL Genome titer or predicted titer range | 9-11 business days | ||
| Identity | Target gene identification | PCR + sequencing | Sample volume> 100 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | |
| Capsid protein identification | SDS-PAGE with Sliver Staining | ＞100μL | 5-7 business days | ||
| Impurity/Residual | E1A residual | qPCR | Sample volume> 100 µl | 5-7 business days | |
| ddPCR | Sample volume> 100 µl | 5-7 business days | |||
| Plasmid residual | qPCR | Sample volume> 100 µl | 5-7 business days | ||
| ddPCR | Sample volume> 100 µl | 5-7 business days | |||
| Aggregation analysis | SEC-HPLC | Sample volume> 100μL | 5-7 business days | ||
| Capsid protein purity | SDS-PAGE with Sliver Staining | ＞50μL | 5-7 business days | ||
| CE-LIF | Sample volume> 30μL | 5-7 business days | |||
| Poloxamer188 content | Residual total Protein | Sample volume> 100μL Sample matrix solution 200μL | 5-7 business days | ||
| PS20/PS80 | UPLC-CAD | Sample volume> 100μL Sample matrix solution 200μL | 5-7 business days | ||
| Affinity ligand residual | ELISA | Sample volume> 100 µl sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| PEI residual | HPLC | Sample volume> 100μL Sample matrix solution 200μL | 5-7 business days | ||
| Distribution of residual DNA fragments | qPCR | Sample volume> 100 µl | 5-7 business days | ||
| CE-LIF | Sample volume>100μL Sample matrix solution 400μL | 5-7 business days | |||
| Empty capsid ratio | AUC | 400μL Sample matrix solution 2mL | 5-7 business days | ||
| SEC-MALS | Sample volume>100μL Information of AAV serotype and sample matrix solution 2ml | 3-5 business days | |||
| Plasmid packing analysis | qPCR | Sample volume> 100 µl | 5-7 business days | ||
| HCD packaging analysis | qPCR | Sample volume> 100 µl | 5-7 business days | ||
| Characterization | Aggregate/Virus particle size | DLS | Sample volume>30μL | 3-5 business days | |
| Virus partical molecular weight | LC-MS | ＞50μL | 7-9 business days | ||
| Peptide mapping | LC-MS | ＞200μL | 7-9 business days | ||
| Post-translational modification | LC-MS | ＞200μL | 7-9 business days | ||
| Glycoform analysis | LC-MS | ＞200μL | 7-9 business days | ||
| Genome integrity analysis | CE-LIF | Sample volume> 50 µl | 5-7 business days | ||
| ddPCR | Sample volume> 50 µl Custom primers/probe sequence and predicted titer range; | 5-7 business days | |||
| Safety | rcAAV | Cell culture+qPCR | Sample volume>300μL | 10-12 business days | |
| Endotoxin | Limulus agent gel method | ＞50μL | 5-7 business days | ||
| Limulus reagent spectrophotometry | ＞50μL | 5-7 business days | |||
| Sterility test | Culture method | ＞4mL | 14-16 business days | ||
| Rapid method | ＞200μL | 5-7 business days | |||
| Mycoplasma (Rapid Test) | qPCR | ＞ 200μL | 5-7 business days |
Porton Advanced’s LV product test list
| Attribute | Testing | Method | Sample Requirement | Testing Period | Note |
| General | Appearance | Visual inspection | Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required | 3-5 business days | The testing period does not include the transportation time. |
| pH (Ph.) | Potentiometric method | ＞500μL | 3-5 business days | ||
| Osmolality (Ph.) | Freezing-point osmometry | ＞300μL | 3-5 business days | ||
| Identity | CAR Gene Identification | PCR | > 100 μL | 5-6 business days | |
| Content | Physical Titer (P24） | ELISA | Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | |
| Potency | Infectious titer | FACS | ＞200μL | 7-9 business days | |
| Infectious titer | Cell culture+qPCR | ＞300μL | 7-9 business days | ||
| Particle to infectivity ratio | Calculation using P24 concentration and infectious titer results | N/A | 7-9 business days | ||
| Impurity | Residual Host Cell Protein (HCP) | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | |
| Residual Benzonase | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual BSA | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual Genomic DNA | qPCR | > 100 μL | 3-5 business days | ||
| Residual DNA | qPCR | > 100 μL | 3-5 business days | ||
| Residual E1A | qPCR | > 100 μL | 3-5 business days | ||
| Residual SV40 | qPCR | > 100 μL | 3-5 business days | ||
| Residual DNA fragment size (>200bp)-1 | qPCR | > 100 μL | 5-7 business days | ||
| Residual DNA fragment size (>200bp)-2 | CE-LIF | ＞400μL | 5-7 business days | ||
| Residual PEG | HPLC-CAD | ＞200μL | 3-5 business days | ||
| Residual PEIpro | HPLC | ＞200μL | 3-5 business days | ||
| Safety | Endotoxin-1 (Ph.) | Limulus agent gel method | ＞200μL | 5-7 business days | |
| Endotoxin-2 (Ph.) | Limulus reagent spectrophotometry | ＞200μL | 5-7 business days | ||
| Sterility-1 (Ph.) | Membrane filtration | ＞1mL | 14-16 business days | ||
| Sterility-2 (Ph.) | Direct inoculation | ＞1mL | 14-16 business days | ||
| Mycoplasma (rapid method) | qPCR | > 200 μL | 5-7 business days | ||
| RCL (VSVG) | qPCR | > 100 μL | 5-7 business days | ||
| RCL (VSVG) | Cell culture with qPCR | > 300 μL | 30 business days |
Porton Advanced’s CAR-T product test list
| Attribute | Testing | Method | Sample Requirement | Testing Period | Note |
| General | Appearance | Visual inspection | Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required | 3-5 business days | The testing period does not include the transportation time. |
| pH (Ph.) | Potentiometric method | ＞500μL | 3-5 business days | ||
| Osmolality (Ph.) | Freezing-point osmometry | ＞300μL | 3-5 business days | ||
| Identity | Car gene identification | PCR | 2.00 E+06 cell | 5-7 business days | |
| Phenotyping (cell activation) | FACS | 2.00 E+06 cell | 3-5 business days | ||
| Immunosubset Modulation | FACS | 3.00 E+06 cell | 3-5 business days | ||
| Cell differentiation | FACS | 3.00 E+06 cell | 3-5 business days | ||
| Strength | Concentration | Cell count | 30-100μL | 3-5 business days | |
| Viability | Cell count | 30-100μL | 3-5 business days | ||
| Purity | CAR+CD3+% cells | FACS | 2.00 E+06 cell | 3-5 business days | |
| CD3+% cells | FACS | 2.00 E+06 cell | 3-5 business days | ||
| Potency | CAR copy number | qPCR | 2.00 E+06 cell | 5-7 business days | |
| IFN-γ | Cell based assay with ELISA | 5.00 E+06 cell | 7-9 business days | ||
| Cytotoxicity-1 | RTCA | 1.00 E+07 cell | 7-9 business days | ||
| Cytotoxicity-2 | CFSE | 1.00 E+07 cell | 7-9 business days | ||
| Impurity | Residual beads | Microscopy method | ＞1mL | 3-5 business days | |
| Residual Antibiotics ( Gentamicin) | ELISA | Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual Antibiotics ( Kanamycin) | ELISA | Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Others | IL-2 | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | |
| Cellular proliferation | FACS | 5.00 E+06 cell | 3-5 business days | ||
| Multicytokine secretion | FACS | ＞100μL | 3-5 business days | ||
| In vitro affinity-1 (antibodies & tumor cells) | FACS | 5.00 E+06 cell | 3-5 business days | ||
| In vitro affinity-2 (antigen & Car-T cells) | FACS | 5.00 E+06 cell | 3-5 business days | ||
| Intracellular protein | FACS | 4.00 E+06 cell | 3-5 business days | ||
| Nuclear protein | FACS | 4.00 E+06 cell | 3-5 business days | ||
| Insulin | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Safety | Endotoxin-1 (Ph.) | Gel-clot technique | ＞200μL | 5-7 business days | |
| Endotoxin-2 (Ph.) | Photometric technique | ＞200μL | 5-7 business days | ||
| Sterility-1 (Ph.) | Membrane filtration | ＞4mL | 14-16 business days | ||
| Sterility-2 (Quick test) | Rapid sterility test | ＞4mL | 5-7 business days | ||
| Mycoplasma (Quick test) | qPCR | > 200 μL | 5-7 business days | ||
| RCL (VSVG) | qPCR | 50-300μL | 5-7 business days | ||
| RCL (VSVG) | Cell culture with qPCR | ＞500μL | 30 business days |
Porton Advanced’s mRNA product test list
| Attribute | Testing | Method | Sample Requirement | Testing Period | Note |
| General | Appearance | Visual inspection | Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required | 3-5 business days | The testing period does not include the transportation time. |
| pH (Ph.) | Potentiometric method | ＞500μL | 3-5 business days | ||
| Identity | mRNA Length | AGE | > 100 μL | 3-5 business days | |
| Purity | A260/A280 ratio | UV spectrophotometry | ＞300μL | 3-5 business days | |
| mRNA Integrity-1 | CGE | ＞200μL | 3-5 business days | ||
| mRNA Purity-1 | HPLC-SEC | ＞200μL | 3-5 business days | ||
| mRNA Purity-2 | RP-IP-HPLC | ＞200μL | 3-5 business days | ||
| mRNA Purity-3 | AUC | ＞400μL | 3-5 business days | ||
| mRNA Recombination Rate | AUC | ＞400μL | 3-5 business days | ||
| Capping Ratio-1 | LC-MS | ＞200μL | 3-5 business days | ||
| Capping Ratio-2 | CGE | ＞200μL | 3-5 business days | ||
| Poly A Tail Length, Distribution | LC-MS | ＞200μL | 3-5 business days | ||
| Poly A Tailing Ratio | ddPCR | > 100 μL | 3-5 business days | ||
| dNTPs | HPLC | ＞200μL | 3-5 business days | ||
| Content | mRNA Concentration | UV spectrophotometry | ＞200μL | 3-5 business days | |
| IVT mRNA Concentration | Oligo-DT-HPLC | ＞200μL | 3-5 business days | ||
| Impurity | dsRNA | ELISA | Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | |
| Residual total Protein | Micro BCA | Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Residual DNA template | qPCR | > 100 μL | 3-5 business days | ||
| Residual Cap Analogue | HPLC | ＞200μL | 3-5 business days | ||
| DNAase | ELISA | Sample volume> 200 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| RNAase | ELISA | Sample volume> 200 µl Information of sample matrix solution 2ml(with buffer info and pH); | 5-7 business days | ||
| Safety | Endotoxin-1 (Ph.) | Gel-clot technique | ＞200μL | 5-7 business days | |
| Endotoxin-2 (Ph.) | Photometric technique | ＞200μL | 5-7 business days | ||
| Sterility-1 (Ph.) | Membrane filtration | ＞4mL | 14-16 business days | ||
| Sterility-2 (Ph.) | Direct inoculation | ＞4mL | 14-16 business days |
Porton Advanced also offers comprehensive testing solutions for:
Please contact us for a comprehensive test list or to explore further analytical development needs with our team of experienced analysts