GLP analysis for metals
GLP metals analysis refers to Good Laboratory Practice. ALS offers method development, validation and analysis of metals under GLP conditions. Metal testing under GLP is e.g. relevant in nonclinical toxicology studies supporting regulatory submissions, typically when metals (or metal-containing drugs, excipients or contaminants) are part of an in vivo study in animals. This includes:
- Dose formulation analysis: Confirm concentration, homogeneity, and stability of dosing solutions/suspensions containing metals.
- Toxicokinetics/biodistribution: Measure metals in blood/plasma, urine, feces, and tissues/organs to characterize exposure, accumulation, and clearance.
- Target organ burden and accumulation: Quantify metals in organs (e.g., kidney, liver or brain) to link exposure with findings.
Please contact us for more information about our GLP-services.
Quality at the GLP laboratory
Our GLP operations by ICP-SFMS undergo all validation steps to ensure that each test meets the relevant validation parameters. The laboratory complies with relevant international regulatory standards including:
- GLP statement of compliance
- GCLP
- GMP
- FDA certificate of registration
- EN-ISO 17025
- ISO 14001
If you would like more information about quality assurance, please visit our page on quality.
Technical capability and validation
- Core study types: Toxicokinetics, bioanalysis, safety pharmacology, medical device biocompatibility and extractables/leachables GLP studies.
- Matrices: Blood, plasma, urine, tissues, organ and other body fluids as well as environmental matrices (soil, sediment, water, biota) if applicable.
- Method development and validation excellence: To date, ALS has successfully validated over 350 client specific methods. We offer validated and accredited analysis of nearly 70 elements in blood, serum, plasma and urine. Services also include method transfer and cross validation.
- Instrumentation and capacity: We operate about 15 ICP-SFMS (High Resolution ICP-MS) in a controlled environment. As such we can offer analysis of about 70 elements at ultra-low levels with a solid backup capacity.
Through robust contamination control, thorough remediation strategies and method development ALS offers measurements of wide ranges in concentrations. - Short turnaround times: Our standard turnaround times are short and the laboratory also offer express analytical and validation services.
- Research: The research conducted at ALS has resulted in nearly 185 scientific articles and conference papers.
More than a lab
From protocol design and method validation to QC and reporting, we work side by side throughout the GLP study.
Our experienced staff and QC team are available to discuss and co-design protocols, establish method validation guidance for the analysis at hand, in your specific sample matrix .