Immunology services for the development
of novel medicines

The advent of biologicals has brought new challenges to drug development. Proteins with immunomodulatory activity such as monoclonal antibodies directed against major switches of the immune system or proteins such as receptor antagonists or agonists may have dramatic effects on immune cell function.

The recent past has shown just how dramatic these effects may be for the well-being of – in this case – volunteers in a clinical study.

The ensuing investigation of this incident resulted in committee recommendations among which the use of human ex vivo / in vitro cultures had a prominent place. This is based on the rationale that biologicals are very often species-specific and thus traditional animal models are in all likelihood not adequate to investigate effects on the immune system.

FOCUS Immunology offers a range of assays to assess the effects of biologicals on different aspects of immune cell activity, which allow a comprehensive analysis of possible immunomodulatory activities.

Specifically, the following assays are provided by FOCUS Immunology : (i) cytokine release, (ii) cell proliferation, (iii) expression of activation markers, (iv) oxidative burst reaction, (v) chemotaxis, (vi) NK cell activity, (vii) cytotoxicity (CDC, ADCC), (viii) NO production, (ix) histamine release, (x) changes in the frequency of defined cell populations.

It may be advisable to test not only resting cells but also cells after suboptimal stimulation in order to account for activation processes which may not suffice by themselves to activate resting cells but may strongly augment activation processes occurring independently.

It also may be advisable to test different means of presenting the tested biological to the cells, from soluble to different types of surface-bound presentation.