During preclinical development, the in-vitro-testing for mode of action of e.g. therapeutic antibodies by cell-based bioassays is of crucial importance. With our GMP certified testing facility and our well-experienced staff, Boehringer Ingelheim Therapeutics performs custom tailoring of a wide range of cell-based bioassays, using FACS , Luminescence, Absorbance, ELISA or Fluorescence (Time Resolved Fluorescence and Fluorescence Polarization) as read outs. Starting from development or optimization by Design of Experiments (DoE) to method validation and release testing, all studies are performed according to GMP guidelines and our customer’s demands. Boehringer Ingelheim Therapeutics is inspected by the US-FDA on a regular basis, as well as European authorities.
At Boehringer Ingelheim Therapeutics numerous types of cell-based-bioassays are established. GMP-compliant testing, required for applications in Europe as well as in the US, are routinely applied. Special focus is put on therapeutic monoclonal or bispecific antibodies, antibody drug conjugates, cytokines, proteins, peptides, antigens or vaccines:
> Reporter Gene Assays
> Proliferation Assay
> Apoptosis Assay
> Competitive Binding Assay
> Binding Assay
> ADCC (commercial and customized)