Testing Services

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Testing Services

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 ATMPs, we help maximize the success of both R&D and commercialization efforts.

  • 01
    Teams that specialize in method development offering over 300 platform methods.
  • 02
    Comprehensive testing that covers plasmids, viral vectors, cell engineering, mRNAs, bacteria, and more.
  • 03
    On-demand Testing services with an Assay-specific focus.
  • 04
    Timely delivery of services and results
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    General
    Appearance Visual inspection Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required3-5 business daysThe testing period does not include the transportation time.
    pH (Ph.) Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Content
    Concentration (A260) UV spectrophotometry >300μL3-5 business daysThe testing period does not include the transportation time.
    Purity
    A260/A280 ratio UV spectrophotometry >100μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid homogeneity HPLC >200μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid homogeneity AGE > 20 μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid supercoil HPLC-SAX >200μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid supercoil CGE >200μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    Restriction digest AGE > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    Residual E.coli HCP ELISA Sample volume> 60 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual antibiotic-1 (Kanamycin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual antibiotic-2 (Gentamicin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual E.coli gDNA qPCR > 20 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA AGE > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA qPCR > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA HPLC 200μL3-5 business daysThe testing period does not include the transportation time.
    Residual total Protein-1 BCA Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual total Protein-2 Micro BCA Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual total Protein-3 Nano Orange Sample volume> 30 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Safety
    Endotoxin-1 (Ph.) Gel-clot technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Endotoxin-2 (Ph.) Photometric technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Sterility-1 (Ph.) Sterility-1 (Ph.) >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-2 (Ph.) Direct inoculation >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-3 (Rapid test) Rapid sterility test >4mL5-7 business daysThe testing period does not include the transportation time.
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    Content
    Vector genome titer-1 (ITR) qPCR Sample volume> 25 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe 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 daysThe testing period does not include the transportation time.
    Vector genome titer-3 (GOI) qPCR Sample volume> 25 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    Vector genome titer-4 (GOI) ddPCR Sample volume> 25 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    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 daysThe testing period does not include the transportation time.
    Potency
    Infectious titer TCID50+qPCR Sample volume>100μL Genome titer or predicted titer range9-11 business daysThe testing period does not include the transportation time.
    Target gene expression cell+WB/ELISA Sample volume>100μL Genome titer or predicted titer range9-11 business daysThe testing period does not include the transportation time.
    Identity
    Target gene identification PCR + sequencing Sample volume> 100 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    Target gene identification PCR + sequencing Sample volume> 100 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    Impurity/Residual
    E1A residual qPCR Sample volume> 100 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    E1A residual ddPCR Sample volume> 100 µl5-7 business daysThe testing period does not include the transportation time.
    Plasmid residual qPCR Sample volume> 100 µl5-7 business daysThe testing period does not include the transportation time.
    Plasmid residual ddPCR Sample volume> 100 µl5-7 business daysThe testing period does not include the transportation time.
    Aggregation analysis SEC-HPLC Sample volume> 100μL5-7 business daysThe testing period does not include the transportation time.
    Capsid protein purity SDS-PAGE with Sliver Staining >50μL5-7 business daysThe testing period does not include the transportation time.
    Capsid protein purity CE-LIF Sample volume> 30μL5-7 business daysThe testing period does not include the transportation time.
    Poloxamer188 content Residual total Protein Sample volume> 100μL Sample matrix solution 200μL5-7 business daysThe testing period does not include the transportation time.
    PS20/PS80 UPLC-CAD Sample volume> 100μL Sample matrix solution 200μL5-7 business daysThe testing period does not include the transportation time.
    Affinity ligand residual ELISA Sample volume> 100 µl sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    PS20/PS80 HPLC Sample volume> 100μL Sample matrix solution 200μL5-7 business daysThe testing period does not include the transportation time.
    Distribution of residual DNA fragments qPCR Sample volume> 100 µl5-7 business daysThe testing period does not include the transportation time.
    Distribution of residual DNA fragments CE-LIF Sample volume>100μL Sample matrix solution 400μL5-7 business daysThe testing period does not include the transportation time.
    Empty capsid ratio AUC 400μL Sample matrix solution 2mL5-7 business daysThe testing period does not include the transportation time.
    Empty capsid ratio SEC-MALS Sample volume>100μL Information of AAV serotype and sample matrix solution 2ml3-5 business daysThe testing period does not include the transportation time.
    Plasmid packing analysis qPCR Sample volume> 100 µl µl 5-7 business daysThe testing period does not include the transportation time.
    HCD packaging analysis qPCR Sample volume> 100 µl µl 5-7 business daysThe testing period does not include the transportation time.
    Characterization
    Aggregate/Virus particle size DLS Sample volume>30μL3-5 business daysThe testing period does not include the transportation time.
    Virus partical molecular weight LC-MS >50μL7-9 business daysThe testing period does not include the transportation time.
    Peptide mapping LC-MS >200μL7-9 business daysThe testing period does not include the transportation time.
    Post-translational modification LC-MS >200μL7-9 business daysThe testing period does not include the transportation time.
    Glycoform analysis LC-MS >200μL7-9 business daysThe testing period does not include the transportation time.
    Genome integrity analysis CE-LIF Sample volume> 50 µl5-7 business daysThe testing period does not include the transportation time.
    Genome integrity analysis ddPCR Sample volume> 50 µl Custom primers/probe sequence and predicted titer range;5-7 business daysThe testing period does not include the transportation time.
    Safety
    rcAAV Cell culture+qPCR Sample volume>300μL10-12 business daysThe testing period does not include the transportation time.
    Endotoxin Limulus agent gel method >50μL>50μLThe testing period does not include the transportation time.
    Endotoxin Limulus reagent spectrophotometry >50μL5-7 business daysThe testing period does not include the transportation time.
    Sterility test Culture method >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility test Rapid method >200μL5-7 business daysThe testing period does not include the transportation time.
    Mycoplasma (Rapid Test) qPCR > 200μL10-12 business days5-7 business days
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    General
    Appearance Visual inspection Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required3-5 business daysThe testing period does not include the transportation time.
    pH (Ph.) Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Osmolality (Ph.) Freezing-point osmometry >300μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    CAR Gene Identification PCR > 100 μL5-6 business daysThe testing period does not include the transportation time.
    Content
    Physical Titer (P24) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Potency
    Infectious titer FACS >200μL7-9 business daysThe testing period does not include the transportation time.
    Infectious titer Cell culture+qPCR >300μL7-9 business daysThe testing period does not include the transportation time.
    Particle to infectivity ratio Calculation using P24 concentration and infectious titer results N/A7-9 business daysThe testing period does not include the transportation time.
    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 daysThe testing period does not include the transportation time.
    Infectious titer Cell culture+qPCR >300μL7-9 business daysThe testing period does not include the transportation time.
    Particle to infectivity ratio Calculation using P24 concentration and infectious titer results N/A7-9 business daysThe testing period does not include the transportation time.
    Residual Genomic DNA qPCR > 100 μL3-5 business daysThe testing period does not include the transportation time.
    Residual DNA qPCR > 100 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E1A qPCR > 100 μL3-5 business daysThe testing period does not include the transportation time.
    Residual SV40 qPCR > 100 μL3-5 business daysThe testing period does not include the transportation time.
    Residual DNA fragment size (>200bp)-1 qPCR > 100 μL5-7 business daysThe testing period does not include the transportation time.
    Residual DNA fragment size (>200bp)-2 CE-LIF >400μL5-7 business daysThe testing period does not include the transportation time.
    Residual PEG HPLC-CAD >200μL3-5 business daysThe testing period does not include the transportation time.
    Residual PEIpro HPLC >200μL3-5 business daysThe testing period does not include the transportation time.
    Safety
    Endotoxin-1 (Ph.) Limulus agent gel method >200μL5-7 business daysThe testing period does not include the transportation time.
    Endotoxin-2 (Ph.) Limulus reagent spectrophotometry >200μL5-7 business daysThe testing period does not include the transportation time.
    Sterility-1 (Ph.) Membrane filtration >1mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-2 (Ph.) Direct inoculation >1mL14-16 business daysThe testing period does not include the transportation time.
    Mycoplasma (rapid method) qPCR > 200 μL5-7 business daysThe testing period does not include the transportation time.
    RCL (VSVG) qPCR > 100 μL3-5 business daysThe testing period does not include the transportation time.
    RCL (VSVG) Cell culture with qPCR > 300 μL30 business daysThe testing period does not include the transportation time.
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    General
    Appearance Visual inspection Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required3-5 business daysThe testing period does not include the transportation time.
    pH (Ph.) Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Osmolality (Ph.) Freezing-point osmometry >300μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    Car gene identification PCR 2.00 E+06 cell5-7 business daysThe testing period does not include the transportation time.
    pH (Ph.) Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Phenotyping (cell activation) FACS 2.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Immunosubset Modulation FACS 3.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Cell differentiation FACS 3.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Strength
    Concentration Cell count 30-100μL5-7 business daysThe testing period does not include the transportation time.
    Viability Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Purity
    CAR+CD3+% cells FACS 2.00 E+06 cell5-7 business daysThe testing period does not include the transportation time.
    CD3+% cells FACS 2.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Potency
    CAR copy number qPCR 2.00 E+06 cell5-7 business daysThe testing period does not include the transportation time.
    IFN-γ Cell based assay with ELISA 5.00 E+06 cell7-9 business daysThe testing period does not include the transportation time.
    Cytotoxicity-1 RTCA 1.00 E+07 cell7-9 business daysThe testing period does not include the transportation time.
    Cytotoxicity-2 CFSE 5.00 E+06 cell7-9 business daysThe testing period does not include the transportation time.
    Impurity
    Residual beads Microscopy method >1mL3-5 business daysThe testing period does not include the transportation time.
    Residual Antibiotics ( Gentamicin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual Antibiotics ( Kanamycin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Others
    IL-2 ELISA Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Cellular proliferation FACS 5.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Multicytokine secretion ELISA >100μL3-5 business daysThe testing period does not include the transportation time.
    In vitro affinity-1 (antibodies & tumor cells) FACS 5.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    In vitro affinity-2 (antigen & Car-T cells FACS 5.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Intracellular protein FACS 4.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Nuclear protein FACS 4.00 E+06 cell3-5 business daysThe testing period does not include the transportation time.
    Insulin ELISA Sample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Safety
    Endotoxin-1 (Ph.) Gel-clot technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Endotoxin-2 (Ph.) Photometric technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Sterility-1 (Ph.) Membrane filtration >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-2 (Quick test) Rapid sterility test >4mL5-7 business daysThe testing period does not include the transportation time.
    Mycoplasma (Quick test) qPCR >200μL5-7 business daysThe testing period does not include the transportation time.
    RCL (VSVG) Cell culture with qPCR 50-300μL5-7 business daysThe testing period does not include the transportation time.
    RCL (VSVG) Cell culture with qPCR >500μL30 business daysThe testing period does not include the transportation time.
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    General
    AppearanceVisual inspectionDepending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required3-5 business daysThe testing period does not include the transportation time.
    pH (Ph.)Potentiometric method>500μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    mRNA LengthAGE> 100 μL3-5 business daysThe testing period does not include the transportation time.
    Purity
    A260/A280 ratioUV spectrophotometry>300μL3-5 business daysThe testing period does not include the transportation time.
    mRNA Integrity-1CGE>200μL3-5 business daysThe testing period does not include the transportation time.
    mRNA Purity-1HPLC-SEC>200μL3-5 business daysThe testing period does not include the transportation time.
    mRNA Purity-2RP-IP-HPLC>200μL3-5 business daysThe testing period does not include the transportation time.
    mRNA Purity-3AUC>400μL3-5 business daysThe testing period does not include the transportation time.
    mRNA Recombination RateAUC>400μL3-5 business daysThe testing period does not include the transportation time.
    Capping Ratio-1LC-MS>200μL3-5 business daysThe testing period does not include the transportation time.
    Capping Ratio-2CGE>200μL3-5 business daysThe testing period does not include the transportation time.
    Poly A Tail Length, DistributionLC-MS>200μL3-5 business daysThe testing period does not include the transportation time.
    Poly A Tailing RatioddPCR> 100 μL3-5 business daysThe testing period does not include the transportation time.
    dNTPsHPLC>200μL3-5 business daysThe testing period does not include the transportation time.
    Content
    mRNA ConcentrationUV spectrophotometry>200μL3-5 business daysThe testing period does not include the transportation time.
    IVT mRNA ConcentrationOligo-DT-HPLC>200μL3-5 business daysThe testing period does not include the transportation time.
    Impurity
    dsRNAELISASample volume> 250 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual total ProteinMicro BCASample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual DNA templateqPCR> 100 μL3-5 business daysThe testing period does not include the transportation time.
    Residual Cap AnalogueHPLC>200μL3-5 business daysThe testing period does not include the transportation time.
    DNAaseELISASample volume> 200 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    RNAaseELISASample volume> 200 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Safety
    Endotoxin-1 (Ph.)Gel-clot technique>200μL5-7 business daysThe testing period does not include the transportation time.
    Endotoxin-2 (Ph.)Photometric technique>200μL5-7 business daysThe testing period does not include the transportation time.
    Sterility-1 (Ph.)Membrane filtration>4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-2 (Ph.)Direct inoculation>4mL14-16 business daysThe testing period does not include the transportation time.
  • Attribute Testing Method Sample RequirementTesting PeriodNote
    General
    Appearance Visual inspection Depending on pakcaging size and dosage form, require minimum of 500μL if subsampling is required3-5 business daysThe testing period does not include the transportation time.
    pH (Ph.) Potentiometric method >500μL3-5 business daysThe testing period does not include the transportation time.
    Content
    Concentration (A260) UV spectrophotometry >300μL3-5 business daysThe testing period does not include the transportation time.
    Purity
    A260/A280 ratio UV spectrophotometry >100μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid homogeneity HPLC >200μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid homogeneity AGE > 20 μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid supercoil HPLC-SAX >200μL3-5 business daysThe testing period does not include the transportation time.
    Plasmid supercoil CGE >200μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    Restriction digest AGE > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Identity
    Residual E.coli HCP ELISA Sample volume> 60 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual antibiotic-1 (Kanamycin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual antibiotic-2 (Gentamicin) ELISA Sample volume> 100 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual E.coli gDNA qPCR > 20 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA AGE > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA qPCR > 40 μL3-5 business daysThe testing period does not include the transportation time.
    Residual E.coli RNA HPLC 200μL3-5 business daysThe testing period does not include the transportation time.
    Residual total Protein-1 BCA Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual total Protein-2 Micro BCA Sample volume> 350 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Residual total Protein-3 Nano Orange Sample volume> 30 µl Information of sample matrix solution 2ml(with buffer info and pH);5-7 business daysThe testing period does not include the transportation time.
    Safety
    Endotoxin-1 (Ph.) Gel-clot technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Endotoxin-2 (Ph.) Photometric technique >200μL5-7 business daysThe testing period does not include the transportation time.
    Sterility-1 (Ph.) Sterility-1 (Ph.) >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-2 (Ph.) Direct inoculation >4mL14-16 business daysThe testing period does not include the transportation time.
    Sterility-3 (Rapid test) Rapid sterility test >4mL5-7 business daysThe testing period does not include the transportation time.

Comprehensive testing solutions

Porton Advanced also offers comprehensive testing solutions for:

  • 01
    Bacterial vectors
  • 02
    TIL, CAR-NK, iPSC, MSC, red blood cells, and other advanced cell engineering products
  • 03
    AdV, BEV, and other viral vector products

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