Bioanalysis and bioanalytical method validation for metals

With more than 25 years of experience in analytical testing of drug products and as part of clinical and pre-clinical studies, ALS in Luleå, Sweden has developed and validated over 350 analytical methods for determining metals and elemental impurities in pharma products for our clients. Bioanalytical method validation and testing capabilities include:

  • Method development and validation
  • Method transfer and cross validation services
  • Stability testing and storage under monitored conditions
  • Bioanalysis of 70+ elements by high resolution ICP-MS
  • Isotope ratios and element speciation in biological matrices

Robust contamination control, thorough remediation strategies and method development allows measurements of a wide ranges in concentrations. This is of particular importance in, for example, pharmacokinetics studies where concentrations can vary from low ppt to percentage levels.

Bioanalytical method validation and metals analysis according to ICH Guideline M10

Adherence to ICH Guideline M10 in the method validation stage will ensure the quality of bioanalytical laboratory data in support for development and market approval of drug products. Laboratory analysis of biological matrices is an important aspect in the assessment of the safety and efficacy of drug products that are under development. As such, method validations are crucial in order to establish that the testing method used is suitable for the intended purpose. 

Our bioanalytical operations by ICP undergo all validation steps to ensure that each test meets the relevant validation parameters. Quality is at our core and the laboratory complies with numerous international regulatory standards.

  • EN-ISO 17025
  • GLP statement of compliance
  • GCLP
  • GMP
  • FDA certificate of registration
  • ISO 14001

Laboratory capabilities

The laboratory in Luleå, Sweden is custom built for high-quality trace metal and ultra-trace elements determination.

By operating the most sensitive analytical instrumentation (ICP-SFMS) in a controlled environment with controlled air flow and temperature, ALS offers trace- and ultra-trace element testing with LOQs matched by few labs worldwide. We have validated and accredited analytical methods for determining 67 elements in:

  • Blood, serum and plasma
  • Urine
  • Stem cells, synovial fluid, sweat, saliva and other body fluids

We offer analytical solutions for measuring 20+ isotopic systems including stable isotopes (e.g. Fe, Cu, Zn, Mo) in biological matrices. Moreover, ALS offers analysis of inorganic arsenic and selenium, methylmercury as well as organotin compounds in biological samples.

Instrumentation

Our comprehensive instrumental park allows us to dedicate certain instruments to different sample types. This allows us to ensure optimal analytical calibrations as well as the ability to offer the lowest possible LOQs. It also ensures a solid backup capacity for our clients.

  • 15 High Resolution ICP-MS (CP-SFMS)
  • 2 multi-collector ICP-MS (MC-ICP-MS)
  • 1 LC-ICP-MS
  • 2 GC-ICP-MS
High resolution ICP-MS (ICP-SFMS)

Bioanalytical research

ALS conducts research in the field of bioanalysis of metals, element speciation and isotope ratios.

Since 1999, research at ALS in Luleå has resulted in over 20 scientific articles and conference papers with thousands of citations. Our research in the field of bioanalytical testing has positioned us in the forefront and we intend to keep this position into the future.

Click here to learn more about the research conducted at the laboratory.