- Overview
- Our Capabilities
- Why Choose Us
Overview
Our company's bioanalytical services cover the entire life cycle of drug development, and the drug forms that can be analyzed include, but are not limited to, small molecules, large molecules, oligonucleotides, and bispecific antibodies. We believe that by providing reliable and comprehensive analytical data, customers can achieve their drug development goals faster and better.
Our Capabilities
Our company provides comprehensive bioanalytical services. Our capabilities are mainly as follows:
Small Molecule Bioanalysis
- Method development, transfer and validation
- Sample Analysis
- Biomarkers by LC-MS/MS
- MS small molecule services
- Nonclinical toxicokinetic /pharmacokinetic screening
- Pharmacokinetic data analysis using validated software systems
- Clinical PK/bioavailability studies
- Bioequivalence studies
- Therapeutic drug monitoring studies
- Drug-drug interaction studies
- Protein binding studies
- Data management using specialist software
Large Molecule Bioanalysis
- LBA and LC-MS/MS analytical method development and validation
- Quantitative analysis in biological fluids and tissues for pharmacokinetic (PK), pharmacodynamic (PD) and toxicokinetic (TK) studies, including:
- Peptides
- Monoclonal antibodies
- Bispecific antibodies
- Proteins
- Oligonucleotides
- Biomarker assays
- Immunogenicity assays:
- Anti-drug antibodies (ADAs): Safety assessment using a tiered approach including ADA screening and positive ADA confirmation.
- Neutralizing antibodies (NAbs) by non-cell based (CLBA) and cell-based assays (CBA).
Biomarker Assays
- Protein biomarker analysis
- Genetic biomarker analysis
- Small molecule biomarker analysis
- Large molecule biomarker analysis
- Preclinical biomarker analysis
- Fit-for-purpose biomarker immunoassay qualification and validation
Why Choose Us
Advanced Technology Platform
Our company is equipped with the most advanced instruments, technologies and infrastructure to support bioanalytical services. These technology platforms improve the accuracy, sensitivity and efficiency of the analysis, providing customers with high-quality results.
Quality Assurance
We adhere to strict quality control measures to ensure the accuracy and reliability of our data. This commitment means that our customers can trust the results we provide and make informed decisions throughout the drug development process.
Customer-Centric Approach
Our company always put customer satisfaction in the first place. We work closely with our customers to understand their unique needs and tailor our services to meet their specific requirements, ensuring their success in drug development.