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Complex biotherapeutics interact with many different molecules in the human body to develop their mode of action.

This increases the possibility of unwanted effects which might result in an unacceptable safety profile or compromise therapeutic efficacy of a compound.  Bioassay offers a panel of assays for assessment of monoclonal antibodies to any kind of recombinant proteins to characterize biotherapeutics in this respect.

Biologics

Antibody-dependent cellular cytotoxicity (ADCC)

  • Neutralizing Antibodies
  • Multi-Cytokine Analysis
  • Immuntoxicology (ITOX3-Panel)
  • Skin Sensitization assays (LLNA, h-Clat & MUSST)
  • Toxicokinetics

Endotoxin-Testing

  • Testing acc. to Pharm.Eur. 2.6.14
  • Turbidimetric & chromogenic