Application
Therapeutic Drug Monitoring
Therapeutic Drug Monitoring (TDM) refers to the clinical practice of measuring specific drug concentrations in a patient's bodily fluids to maintain therapeutic effectiveness while preventing toxicity. This practice aims to optimize drug efficacy while minimizing toxicity, especially for medications with narrow therapeutic windows.
There are several techniques for measuring drug levels in clinical drug safety and TDM. Historically, immunoassays have been the gold standard for analyzing small molecules in clinical chemistry. However, Liquid Chromatography-Mass Spectrometry (LC-MS) applications have gained prominence in recent years for their superior precision and accuracy. Other less common methods include High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and Capillary Electrophoresis (CE).
How Hamilton Supports Your Therapeutic Drug Monitoring Workflows
1
Dose Schedule
A diagnosis is made, and a drug is selected. A dosage schedule is designed to reach a target therapeutic plasma concentration. The drug is administered to the patient.
2
Sample Testing
Samples are collected from the patient at repeated intervals and tested in a clinical laboratory using Liquid Chromatography coupled with Mass Spectrometry (LC-MS) or Immunoassays.
3
Dosage Adjustment
Drug concentration in the patient’s blood/ plasma is determined. A pharmacokinetic model is applied, and clinical judgment is used to adjust the dosage if necessary.
Hamilton provides liquid-handling solutions that automate sample preparation for LC-MS analysis and immunoassays.
For LC-MS sample preparation in TDM studies, Hamilton provides four standardized Assay-Ready Workstations: MassSTAR, STAR CL, MassXtract, and Dual MassSTAR. The first two platforms were developed as CE-IVD-certified automated solutions for clinical LC-MS sample preparation in collaboration with Chromsystems and Shimadzu.
Our automated liquid handlers for immunoassays are offered as customized solutions. They leverage on-deck modules for heating, shaking, and cooling, and seamless third-party integration with plate readers and washers, among other things. Additionally, the software scheduler optimizes resource allocation for parallel assays.
For laboratories conducting manual workflows, Hamilton’s portfolio includes fixed and adjustable-volume manual pipettes, enabling accurate and efficient liquid handling.
Explore our Therapeutic Drug Monitoring Solutions and Applications in Detail
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The Hamilton Microlab Prep is an affordable liquid handler perfect for automating workflows. This entry-level liquid handler supports automated PCR setup and serial dilution.
The Hamilton Microlab STAR is a reliable and versatile automated liquid handling platform. With advanced features like multi-probe heads, pipetting technologies, and VENUS software, this premier liquid handling system fits your laboratory needs. Revolutionize your workflows with the STAR today!
Hamilton STAR V, a cutting-edge liquid handling robot, unites Microlab STAR flexibility with Microlab VANTAGE high-performance capabilities to boost efficiency. The Microlab STAR V offers speed, precision, and technology for automated liquid handling. Upgrade your lab—explore the Microlab STAR V!
Hamilton VANTAGE 2.0 is a cutting-edge liquid handling system with automated precision. Optimize workflows with the VANTAGE robot, all while boosting performance, safeguarding samples, and maximizing walk-away time. Discover the Hamilton VANTAGE liquid handler for your current & future needs.
Hamilton offers a wide range of chromatography syringes for HPLC and GC, designed for precise and accurate sample injections. Their catalog includes replacement autosampler syringes for popular HPLC and GC systems, as well as manual syringes for on-column, headspace, and split/splitless injections, plus specialized syringes and needles for TLC.
Good to Know About Nucleic Acid Extraction Workflows
This section provides a selection of additional resources related to the application described on this page. It includes helpful articles, videos, and blogs that offer deeper insights into the topic.
Useful Links
External resources not written by Hamilton but valuable for understanding the topic, such as industry guidelines, explanatory videos, or relevant tools.
| Chromsystems Webinars | Visit Website |
Solutions for the Top 3 Challenges for Nucleic Acid Extraction Workflows
Tracing samples from primary blood tubes to final reports.
Solution: Hamilton liquid handlers integrate barcoding technology and software that monitors all on-deck movements, synchronizes with third-party devices and Laboratory Information Management Systems (LIMS), and ensures seamless sample tracking for full traceability and regulatory compliance. These systems eliminate manual errors, providing transparent data handling and reducing risks in TDM workflows.
Blood clots and insufficient sample volumes.
Solution: Hamilton liquid handlers utilize Total Aspiration and Dispense Monitoring (TADM) to:
- Detect clots, foaming, or insufficient sample volumes in real-time.
- Flag problematic samples to prevent processing errors.
- Automate error detection and reporting, ensuring accurate sample preparation.
TADM enhances workflow efficiency and accuracy by minimizing issues with sample quality control.
Complete CE-IVD-certified workflow in TDM is required (in Europe).
Solution: Hamilton, in collaboration with Chromsystems and Shimadzu, offers CE-IVD-certified solutions for LC-MS sample preparation: Chromsystems’ MassSTAR and Alsachim’s STAR CL. These systems provide pre-validated methods, comprehensive documentation, and scalable solutions, ensuring compliance with CE-IVD standards and streamlined TDM workflows.
What Are the Advantages of LC-MS Compared to Immunoassays in Automated Drug Testing?
Immunoassays have historically dominated as the primary technique for molecular analysis in clinical chemistry.
These tests rely on antibody-antigen binding; however, they are subject to several limitations, such as (1) limited specificity due to cross-reactions, (2) limited reproducibility caused by antibody lot-to-lot variations from the same manufacturer, and/or discordance between the results obtained from assays from different manufacturers, and (3) limited sensitivity, due to the low linear dynamic range. Furthermore, since every analyte requires a specific antibody, many do not have a commercially available immunoassay.
Liquid Chromatography Mass Spectrometry (LC-MS) has become a leading alternative to traditional immunoassays and other popular enzyme-subtract tests, as it overcomes immunoassay limitations.
LC-MS is highly (1) specific and (2) reproducible, as it identifies compounds based on their unique chemical structure without the need to use antibodies, as well as (3) sensitive due to its high linear dynamic range. These unique features enable the detection of steroids and other analytes that are difficult to measure at low concentrations. Additionally, LC-MS allows for the simultaneous analysis of a wide range (up to hundreds) of compounds from the same sample during the same run.
Which are the most Common Sample Types on which to do TDM?
The primary sample types for TDM are biological samples and fluids that reflect the concentration of the drug in the body. The choice of sample type depends on the drug's pharmacokinetics and clinical need. Below are the primary sample types:
- Blood (Plasma or Serum)
- Whole Blood
- Urine
- Saliva
- Cerebrospinal Fluid (CSF)
- Dried Blood Spots (DBS)
Key Considerations for Sample Type Selection
- Drug Characteristics: Binding to plasma proteins or distributing into blood cells.
- Patient Factors: Convenience and invasiveness for the patient.
- Analytical Method Sensitivity: The ability to accurately quantify drug levels in a given sample type.
Blood (plasma/serum) remains the gold standard for most TDM applications due to its reliability and ability to reflect systemic drug exposure.
Therapeutic Drug Monitoring Case Studies and Application Notes
Other Therapeutic Drug Monitoring Resources
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
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