Bioanalytics

  • Fast method development or implementation of methods supplied by the client for all relevant matrices, such as biofluids and tissue from various animal species and humans
  • Method validation or qualification depending on the purpose according to current FDA guidelines.
  • Quantitative analysis of more than 200 new chemical entities (NCEs) or registered drugs in various study types, including preclinical and clinical programs. Current throughput is more than 100,000 samples/year. All data are completely QC checked.
  • Metabolite identification can be performed by high resolution mass spectrometry (Bruker Daltonics MaXis TOF-MS) and by access to NMR at a subcontractor.
  • Certificates of analysis for reference standards (GLP or GMP) can be provided, if not supplied by the client.
  • Broad experience in sample preparation by methods such as protein precipitation, solid phase extraction, liquid-liquid extraction and solid-supported liquid extraction, in 96-well format. These can either be performed manually or by a liquid handling robot.
  • Online sample preparation and column-switching techniques.
  • Methods for dried blood spot analysis
  • Analysis of macromolecules by ELISA, Western Blotting and PCR
  • Biodistribution studies for macromolecules
  • Equipment for biochemical analysis of macromolecules includes FACS, gamma counters, liquid scintillation counters and electrophoresis.

 

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