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Bioanalysis

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

Type of projects

Specialized in customized solutions for pharmacokinetic (PK) and toxicokinetic (TK) studies, focusing on precise measurement of new drugs in specific matrices. Our expertise extends to developing novel methodologies for analyzing new modalities. We offer robust assays that ensure sensitive and quantitative measurements of drug concentrations.

Molecule types

Specialized not only for small organic molecules but also peptides with a molecular weight of less than 10kDalton.

Matrices

Extensive experience with a wide spectrum of biological matrices, including but not limited to serum, blood, tissues, cells, spinal fluid, tears, and urine.

Turnaround time

Capabilities and resources allow quick turnaround times. Typically, we require three weeks for method development and another three for method validation, subject to project specifics.

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:

Technological-Assets-Agilent-6460

Agilent 6460 triple quadrupole

Utilized for analyzing compounds, particularly beneficial for charged species like peptides, necessitating the use of ion-pair reagents to enhance chromatography.

Technological-Assets-Agilent-6495

Agilent 6495 triple quadrupole

With iFunnel technology to improve signal intensity and accuracy.

Technological-Assets-Xevo

Waters Xevo TQ-XS triple quadrupole

Coupled with the ACQUITY Premier chromatographic system designed to improve separation and detection of metal-sensitive analytes.

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.

Partnering

Scantox is your bioanalytical partner throughout your entire drug development program