- Overview
- Our Capabilities
- Small Molecule Bioanalysis Using MS
- Partnering with Us
Overview
Small molecule bioanalysis in drug development is the process of quantifying and characterizing small molecules, such as drug compounds, metabolites, and biomarkers, in biological samples (e.g., blood, urine, or tissues) in order to assess their pharmacokinetic properties and understand their effects on the body. This information is crucial for determining the safety, efficacy, and proper dosing of a drug candidate during preclinical and clinical development stages.
We have rich experience and professional knowledge in small molecule bioanalysis. No matter how complex your bioanalytical challenge, we will help you achieve outstanding results.
Our Capabilities
- 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
Small Molecule Bioanalysis Using MS
Mass spectrometry (MS) stands as a powerful analytical technique widely utilized in small molecule bioanalysis, offering a plethora of advantages crucial for modern drug development. These advantages are mainly as follows:
Sensitivity
One of the primary advantages of MS in small molecule bioanalysis is its exceptional sensitivity. MS can detect analytes at trace levels, often down to picogram or femtogram concentrations. This high sensitivity enables the quantification of drugs and metabolites in complex biological matrices, such as plasma or tissue samples, even at low concentrations. As a result, MS helps to detect subtle pharmacokinetic changes and deepen the understanding of drug metabolism and distribution profiles.
Selectivity
MS offers unparalleled selectivity in small molecule bioanalysis, allowing for the specific identification and quantification of target analytes amidst complex sample matrices. By leveraging the unique mass-to-charge ratios of ions, MS can distinguish between analytes and matrix interferences with high precision. This selectivity minimizes the risk of false-positive or false-negative results, ensuring the accuracy and reliability of quantitative data obtained from bioanalytical tests.
Dynamic Range
Another advantage of MS is its wide dynamic range, which can span several orders of magnitude. This dynamic range allows for the simultaneous detection and quantification of analytes ranging from low abundance metabolites to high concentration parent drugs. This facilitates comprehensive pharmacokinetic studies and biomarker discovery efforts using MS without the need for sample dilution or concentration.
Robustness
MS is known for its robustness and reproducibility, which makes it an ideal platform for routine bioanalytical applications. MS instruments exhibit high stability and consistency across multiple analytical runs, minimizing variability and ensuring the reliability of analytical results. In addition, advancements in instrument design and software algorithms have enhanced the robustness of MS-based assays, enabling seamless integration into high-throughput screening workflows and automated sample processing systems.
Partnering with Us
Our team is well-versed in science, staying current with regulations, and mastering the latest instruments. They have a proven track record of successfully working with challenging compounds and complex biological matrices. With the expertise and organizational capabilities of our team, your bioanalytical projects will be carried out efficiently and economically in our system.