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Preclinical testing of phamaceutical and medical products

The complex process of drug development end evaluation is driven by a vast number of regulations and guidelines dealing with drug efficacy and safety. A specific compound might be tested in vitro and in vivo according to different types of parameters such as

  • Biological mode of action (pharmacodynamics: PD)
  • Kinetics and metabolisation in the body (pharmacokinetics: PK)
  • Toxicological aspects in general
  • Wanted and unwanted immunogenicity
  • Adverse side effects such as hypersensitivity

At MicroMol we help our clients to conduct preclinical studies, to test safety and efficacy of active components and to analyze pharmacokinetics for new drug candidates. We help you fulfilling international regulatory requirements and getting regulatory submission for clinical trials or marketing authorisation. We are your CRO.

MicroMol offers, according to a long lasting experience in preclinical / immunological test implementation a broad spectrum of analytical features, in detail:

  • Determination of a defined analyte by ELISA
  • Determination of a defined analyte by Western Blotting
  • Immunophenotyping of cell lines and immune cells (PBMCs)
  • Determination of expression profiles by Flow Cytometry
  • Determination of immune cell (PBMC) reactivity on the single cell level by ELISpot
  • Determination of defined analyte by PCR /end point and real time)
  • Performance of analyte specific PD studies
  • Performance of analyte specific PK studies
  • Customized implementation of analyte specific PD and PK analytics
  • Determination antibody dependent cellular cytotoxicity (ADCC)
  • Determination of complement dependent cellular cytotoxicity (CDC)
  • Determination of Apoptosis

 

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