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Analytical Development and Testing

As a trusted CDMO partner in CGT, skilled analytical teams are experts in method development, qualification, and validation in CGT products including plasmids, lentiviruses, AAVs, OVs, bacterial vectors, mRNAs, and various cell engineering products.

  • Laboratory Facilities: 29,000 sq. ft
  • Advanced Analytics: Over 300 established platform methods covering more than 10 CGT product types.
  • cGMP-Compliant QC Platform: Supports FDA EMA, and NMPA filings.
  • First-Class Laboratory Management Systems: LIMS, Empower, ELN, LabX, and more.
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Analytical Development
and Quality Control

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Functional
Platforms

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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 CGT products, we help maximize the success of both R&D and commercialization efforts

  • Teams that specialize in method development offering over 300 platform methods.
  • Comprehensive testing that covers plasmids, viral vectors, cell therapies, mRNAs, bacteria, and more.
  • On-demand Testing services with an Assay-specific focus.
  • Timely delivery of services and results

Testing List

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 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'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 offers comprehensive testing solutions for bacterial vectors. Please inquire to
obtain a comprehensive test list or to explore further analytical development needs with our
team of experienced analysts.

 

Porton Advanced offers various testing solutions for TIL, CAR-NK, iPSC, MSC, red
blood cells, and other advanced cell therapeutic products. Please inquire to obtain a
comprehensive test list or to explore further analytical development needs with our
team of experienced analysts.

Porton Advanced offers various testing solutions for AdV, BEV, and other viral vector
products. Please inquire to obtain a comprehensive test list or to explore further
analytical development needs with our team of experienced analysts.

Testing List

(Applicable for Bacterial Vector)

Porton Advanced offers comprehensive testing solutions for bacterial vectors. Please inquire to obtain a comprehensive test list or to explore further analytical development needs with our team of experienced analysts.

(Applicable for Other Cell Therapies)

Porton Advanced offers various testing solutions for TIL, CAR-NK, iPSC, MSC, red blood cells, and other advanced cell therapeutic products. Please inquire to obtain a comprehensive test list or to explore further analytical development needs with our team of experienced analysts.

(Applicable for Other Virus Vectors)

Porton Advanced offers various testing solutions for AdV, BEV, and other viral vector products. Please inquire to obtain a comprehensive test list or to explore further analytical development needs with our team of experienced analysts.

Contact Us

Please email us through info@portonadvanced.com with your inquiry, or submit a contact form below: