Bioanalysis
Pharmacokinetic
Quantitatively evaluating drug absorption, distribution, metabolism, and excretion (ADME) in the body, we conduct pharmacokinetic (PK) analysis across diverse modalities, from small molecules to protein therapeutics and ADCs.
- Blood Drug Concentration Quantification
- Small & Large Molecule Drug PK Analysis
- ADC Pharmacokinetic (PK) Analysis
(Total Antibody, Drug-Conjugated Antibody & Free Payload Quantification) - Tissue Distribution (Biodistribution) Analysis
Immunogenicity
Detecting anti-drug antibodies (ADA) following the administration of biotherapeutics and systematically evaluating neutralizing capacity. These assessments are conducted using a tiered testing approach in strict compliance with regulatory guidelines.
- Anti-drug antibody (ADA) Screening & Confirmatory Testing
- Neutralizing Antibody (NAb) Analysis
- Antibody Isotype / Subclass Analysis
- Cut Point Determination & Statistical Analysis
Biomarker
Precisely quantifying biomarkers used for predicting therapeutic efficacy, screening, and monitoring drug responses. We provide optimal analytical solutions tailored to sponsors' specific objectives, ranging from single markers to multiplex panels.
- Cytokine / Chemokine Analysis
- CSF / Plasma Amyloid-β42 Quantification (Neurodegeneration)
- Tumor Biomarker Analysis (PD-L1, etc.)
- Metabolic Biomarker Analysis (GLP-1, Insulin, etc.)
Cell-Based
We provide comprehensive cell-based analytical services for evaluating immune cell phenotypes, cellular functions, and cytotoxicity. Our capabilities include PBMC isolation and cryopreservation, NK cell activity assays, and quality assessment of cell therapy products.
- PBMC Isolation & Long-term Cryopreservation
- Immune Cell Phenotype Analysis (Lymphocyte subset)
- T Cell Functional Analysis (ELISpot)
- CAR-T / CAR-NK Functional Evaluation
Genomics
Providing nucleic acid-based analysis services, including viral load measurement, gene expression quantification, and biodistribution evaluation for cell and gene therapies. We support precision genetic analysis throughout the entire clinical trial lifecycle.
- Viral Load Quantification (Viral Burden/Shedding)
- Gene Expression Analysis
Clinical Laboratory
Leveraging strategic partnerships with U2Labs and Samkwang Medical Lab, U2XLab provides comprehensive clinical laboratory testing services for clinical trial samples.
Conducted in U2XLab's GCLP-certified lab, our precision diagnostic assays deliver highly reliable data and on-time results, and we support clinical development with flexible solutions tailored to meet sponsors' specific needs.
Test-Specific Analytical Methods and Instruments
For any services not listed, please submit an inquiry via Contact > Make Inquiry or use the Make Inquiry button at the top of the homepage.
| Test Item | Method | Instrument |
|---|---|---|
| CCK (cholecystokinin) | ELISA | Epoch |
| CD14+(CD3-CD19) | Flow Cytometry | FACSverse |
| CD16/CD56+ | Flow Cytometry | FACSverse |
| CD16+CD56- | Flow Cytometry | FACSverse |
| CD16+CD56+ | Flow Cytometry | FACSverse |
| CD16-CD56- | Flow Cytometry | FACSverse |
| CD16-CD56+ | Flow Cytometry | FACSverse |
| CD19+ | Flow Cytometry | FACSverse |
| CD19+(CD3-CD138-CD16,56-) | Flow Cytometry | FACSverse |
| CD200 | ELISA | Epoch |