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  Services  »  Target Finding & Biological Profiling

Target Finding & Biological Profiling

One of the most challenging tasks in preclinical drug development concerns target finding and characterization of a compound’s biological properties.

 

Characterization of biological properties

The fact that most compounds have not only a single primary but many, mostly poorly defined secondary targets complicates the characterization. Insufficient knowledge of biological compound effects has resulted in ever decreasing numbers of drug approvals and a costly increase in late stage attrition.

Pharmacelsus supports its customers navigating through the difficult task of understanding the biological properties of their compounds. This will ultimately reduce costly attrition and boost overall success rates.

In vitro toxicology in accordance to the EMA guidances/guidelines ICH S2, S6, S7a and S8

flow cytometry

Several International Conference on Harmonisation (ICH) guidelines and guidances specifically encourage the use of flow cytometry as suitable tool regarding immunotoxicity studies for human pharmaceuticals prior to entering clinical trials.

Flow Cytometry

Flow cytometry technologies are capable of measuring multiple parameters of single cells at a rapid rate. Pharmacelsus has added several flow cytometry-based assay systems specifically designed to comply with regulations and to speed up drug development.

Cellular assays for oncology, inflammation, immune modulation, diabetes & obesity

Following is a selection of Pharmacelsus’ service offerings for small molecules and biopharmaceuticals:

  • Multivariate modeling in primary cells and cell lines (preclinically relevant species)
  • Preclinical safety profiling (e.g. human hepatotoxicity)
  • In vitro / in vivo regulatory toxicity testing (genotoxicity, immunotoxicity)
  • In vitro efficacy and potency testing (oncology, dose-response curves, EC50, IC50)
  • In vitro drug combination studies (novel IP & patents, drug repositioning)
  • Alternative indications (novel IP, patent extension, drug repositioning)
  • In vitro bioequivalence studies (biogenerics)
  • Immune modulation / stimulation / sensitization
  • In vitro / in vivo cytokine release / suppression studies
  • Varies in vitro disease models
  • In vitro prediction of in vivo LD50 (NIH)