Trace Metal Bioanalysis and Biomarker Quantification by ICP-MS

Trace metal bioanalysis by inductively coupled plasma mass spectrometry (ICP-MS) offers a quantitative and highly selective approach to elemental bioanalysis for pharmacokinetics studies (PK) involving metal containing drugs or quantification of metals during biomarker or biomonitoring studies.

Metal Bioanalysis for Preclinical or Clinical Studies
Metal containing drugs are currently being evaluated for a range of therapeutic applications including cancer, arthritis, diabetes, and cardiovascular diseases. Examples include the use of platinum in cis-platin anti-cancer drugs or gold in rheumatoid arthritis drugs. Medical devices such as implants, or pacemakers may also impart metal elements - such as titanium or chromium or nickel that may leach from the device. Determining these metals in preclinical and clinical samples is vital, however, the analysis of these elements at very low detection limits in complex biological matrices can present challenges.

Biomarker Quantification
Recently there has also been increased interest in identifying metal element biomarkers that can give high specificity and sensitivity to aid diagnosis of a disease. If biomarkers can be established to predict the likelihood of risk of developing the disease perhaps decades before they would typically develop, then this assists healthcare providers in determining suitable treatment programs.

Human Biomonitoring
Metal bioanalysis is key to Human Biomonitoring (HBM) studies where the measurement of biomarkers (parent chemical and/or its biotransformation products) in human biological fluids or tissues are used as a tool for quantifying human exposure to chemicals in order to inform public health, risk assessment, and risk management decisions.

Global Metals Bioanalysis Expertise 
We deliver accurate, selective, and robust data for element specific quantitative bioanalytical evaluation of metals or other elements at very low levels, even down to parts-per-trillion (ppt) with few matrix interferences using inductively coupled plasma with mass spectrometry detection (ICP-MS). Our clinical assay team are adept at method development and validation and apply this technology to quantification of metal elements across a wide range of clinical samples including plasma, serum, whole blood, and other matrices.

Intertek offers a range of technologies, including ICP-MS in a Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) compliant lab environment to determine levels of trace metals and other inorganic elements in clinical samples - to support global drug discovery, drug development, and the safety assessment of implantable medical devices. In addition, our European facility in the UK has an on-site Class II Bio sample handling laboratory and a Human Tissue Licence, enabling the handling of clinical and diagnostic specimens.

Bringing quality and safety to life, we apply our Total Quality Assurance expertise to support your bioanalysis or biomarker programs - with a focus on developing the best possible methodologies for your requirements that comply with the latest industry guidance.

Metals Bioanalysis Services

• Rapid discovery phase bioanalysis
• Method development
• Method validation (GLP/GCP)
• Method transfer
• GLP/GCP quantitative analysis
• Biomarker studies
• Biomonitoring studies
• Statistical support
• Elemental mapping of tissue samples with electron microscopy (SEM-EDX)
• Detection and quantification of anions and cations such as phosphate, halide, sulphate, sodium and other alkali metals, ammonium salts and amino acids by ion chromatography

Metals and Inorganic Bioanalysis Case Studies

• Detection and quantification of trace metal elements using ICP-MS in cell lysates
• Metal ion release in plasma from prosthetic implants using ICP-MS
• Labelling with gold colloids and other staining techniques of tissue samples for imaging with transmission electron microscopy (TEM)
• GCP studies for the determination of inorganic elements from consumer healthcare clinical development
• Evaluation of active ingredient deposition in skin, hair and other tissues