Immunology services for the development
of novel medicines

In a recent issue of “Nature Biotechnology” (Volume 28, Nr. 4, April 2010) Cormac Sheridan featured the status of biologicals development in 2009. From this and the associated specific articles on monoclonal antibody development it is obvious that biologicals are gaining more and more importance for sustaining the new products pipelines of pharmaceutical companies.

The development of new biologicals is associated with specific challenges. Some relate to the immunogenic and immune-modulatory properties of biologicals. Some keywords are „immunogenicity testing”, “cytokine storm”, “species-specificity of ligand-receptor interactions and down-stream signaling”.

In view of these challenges FOCUS has developed specific testing packages with an emphasis on immuno-modulatory activities of novel drug candidates.

The following testing packages have recently been defined:

1. Specific immune system package
2. Innate immune system package
3. Immune activity screening package for novel and established compounds
4. Cytokine modulation package for immuno-modulators, esp. immuno-suppressive compounds
5. Immuno-stimulation package for immune-modulators, vaccines and oncology drugs
6. Biologicals testing package, esp. for new biological entities (NBEs)

A comprehensive summary can be found in the white paper to be downloaded here.

Source: Cormac Sheridan, „Fresh from the biology pipeline-2009“ Nature Biotechnology Volume 28 Number 4 April 2010