Precision Biomarker & Pharmacokinetic Testing for Accelerated Drug Development
At HT Biotechnology, our Quantitative Analysis Platform delivers end-to-end solutions for preclinical drug development, combining cutting-edge technologies with GLP-compliant workflows. We provide pharmaceutical, biotech, and academic partners with high-sensitivity, reproducible data to support pharmacokinetic (PK), pharmacodynamic (PD), and toxicology studies, ensuring robust insights from lead optimization to regulatory submissions.
Core Services
Pharmacokinetics (PK) & ADME Studies
- Drug Concentration Analysis:
Quantification of small molecules, biologics, and metabolites in plasma, tissues, and biofluids (LC-MS/MS, HPLC).
Absolute bioavailability (BA) and bioequivalence (BE) assessments.
- ADME Profiling:
Absorption: Caco-2 permeability, plasma protein binding.
Distribution: Tissue-to-plasma ratio analysis, mass spectrometry imaging (MSI).
Metabolism: In vitro hepatocyte/microsomal stability, metabolite identification.
Excretion: Biliary, renal, and fecal clearance studies.
Pharmacodynamics (PD) & Biomarker Analysis
- Target Engagement:
Receptor occupancy, enzyme inhibition kinetics (SPR, ELISA).
Pathway activation/inhibition (phosphoprotein quantification, Western blot).
- Biomarker Quantification:
Cytokines, chemokines, and disease-specific markers.
Circulating tumor DNA (ctDNA), exosome profiling.
Toxicology & Safety Assessment
- Organ Toxicity Markers:
Hepatic (ALT, AST), renal (BUN, creatinine), cardiac (troponin) panels.
Histopathology-integrated tissue distribution studies.
- Genotoxicity: Comet assay, micronucleus test scoring.
- Immunotoxicity: Cytokine storm profiling, complement activation assays.
Bioanalytical Method Development
- Small Molecules: LC-MS/MS method validation.
- Large Molecules: ELISA, Gyrolab®, and SPR for antibodies, ADCs, and gene therapies.
- Anti-Drug Antibody (ADA) Testing: Neutralizing antibody (NAb) detection.
Advanced Omics Integration
- Metabolomics & Lipidomics: LC-MS/GC-MS-based quantification of metabolic shifts.
- Proteomics: Targeted/untargeted protein expression profiling.
