Bioanalytical Capabilities
Scantox provides a comprehensive bioanalytical package of LC-MS/MS method development, validation, and sample analysis. Our bioanalytical experts bring experience and scientific knowledge to guide your assay strategy from exploratory to regulatory studies.
Services:
- Assay of organic compounds
- Analytical method development
- Analytical method validation ensuring adherence to ICH and/or EMA guidelines
- Sample analysis for toxicological & pharmacokinetic studies meeting GLP/GCP standards
- Analytical method transfer
- Batch control testing of raw materials & finished products, in line with GMP standards
Technological Assets
Our state-of-the-art laboratory is equipped with an integrated instrumental set-up consisting of LC-MS/MS models from leading vendors. This equipment enables the selection of the optimal method for specific analyte, matrix, and LLOQ requirements, even with limited sample volumes.
We are committed to continually updating our technology and software to take on new innovative projects and meet the needs of all our customers.
Instrument overview:
What is LC-MS/MS?
LC-MS/MS is recognized as the gold standard technology used for the bioanalysis of small molecules in drug discovery and development. This technology is instrumental in the qualitative and quantitative analysis of drugs and other compounds in biological fluids and tissues. Its application spans across various study phases, from non-GLP exploratory research to GLP-compliant studies to GCP clinical trials.
Certifications
At Scantox, dedication to excellence is at the core of every action. We adhere to the highest standards of GMP, GLP, and GCP. This commitment is validated through regular audits by SWEDAC and the Swedish Medical Products Agency (MPA), alongside inspections from our clients, ensuring compliance with these critical regulations.
We validate our methodologies in strict accordance with the International Council for Harmonisation (ICH) guidelines and the European Medicines Agency’s (EMA) guidelines for bioanalysis. This ensures that our processes meet global standards for quality and reliability.
Why Choose Us?
- Extensive Expertise: Highly trained scientific staff with different types of analytes and LCMS/MS bioanalytical method development and validation
- Engagement & Reliability: Committed to flexibility and maintaining open lines of communication, both within our team and with sponsors, to ensure project needs are understood and met. Reputation on meeting actual timelines.
- Tailored Solutions: The focus lies on developing lean, cost-effective, and reliable methods designed to address unique client needs.
Contributors
The bioanalytical team is strategically located at the BioVentureHub, a part of AstraZeneca’s Life Science cluster in Gothenburg, Sweden.
Led by recognized bioanalytical chemists, Gunnar Hägglund and Henrik Tjellström, the contract lab operates with a team of 17 qualified scientists and technicians. Their core expertise: Deep understanding of LC-MS/MS bioanalysis of small molecules and a long regulatory track record. The team stands out for its ability to deliver tailored problem-solving experience for complex bioanalytical challenges of new molecules.
Gunnar Hägglund
M.Sci in Analytical Chemistry from Umeå University. He established the bioanalytical lab at Scantox Gothenburg and brings over 13 years of experience as a principal scientist at Scantox where he is principal investigator for Tox studies and oversees both GCP and non-GxP studies.
Henrik Tjellström
PhD in Plant Molecular Biology from University of Gothenburg. 20+ years research experience in both industry and academic settings. Since 2015 he has been a part of Scantox Gothenburg as Principal Investigator.