Services

Bioanalysis

ELISA is a powerful tool for detecting and quantifying proteins down to the nanomolar concentration range. We have decades of experience with validating ELISA in accordance with current regulations and in studies with a wide range of sample matrices (especially serum, plasma, urine and stool).

Along with ELISA, we can perform enzyme activity assays as a high-throughput method in 96-well microplates or in a cuvette as needed.

For the quantification of RNA-based drugs in biological matrices and formulation solutions, we offer sandwich hybridization assays in the 96-well format.

With our microplate readers, we cover a wide range of detection options: not only UV/VIS absorption and fluorescence, but also luminescence and fluorescence polarization. The readers are controlled by GxP software that is certified according to 21 CFR Part 11, which means that we can perform all assays in compliance with all the latest GMP/GCP/GLPs.

We develop and validate your assay to meet your specific requirements in accordance with current guidelines (FDA/EMA/ICHQ2R, Pharmacopoeia) as well as the specific requirements for your research.

Methods

  • ELISA (Enzyme-linked immuno­sorbent assay)
  • Enzyme activity assays (kinetic and endpoint)
  • Sandwich hybridization assays

Applications

  • GLP and GCP analysis for:
  • Pharmacokinetics
  • Biomarker analysis
  • Toxicokinetics
  • Preclinical trials in conventional animal models (monkey, rat, mouse, dog)
  • Phase I-III clinical trials
  • Supporting analyses for drug approval under GMPs:
  • Content determination of raw and finished products
  • Enzyme-based potency assays
  • Impurity measurements

Contact

If you would like to start talking about how we can help you, or if you’re still not sure if we can address your needs and you have questions, don’t hesitate to get in touch with us.