Bioactivity Assays
Bioactivity of final products is an essential parameter in the specification of a biopharmaceutical drug substance. ORPEGEN's capabilities covers various technology platforms for assay development such as:
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Combined with our expertise in GCLP assay development, ORPEGEN has a track-record for establishment of qualified and validated methods used in product quality control. In addition, our know-how in immunology and routine-assay development has been successfully used to establish and monitor suitable in-vitro read-out parameters for pre-clinical or clinical studies. Our biological focus is put on :
- Custom-tailored functional lymphocyte assays for analysis of migration capabilities, burst-activity, induction of degranulation, etc.
- Custom-tailored NK cell cytotoxicity assays
- Custom-tailored lymphocyte proliferation assays
- Antibody-dependent cell-mediated cytotoxicity (ADCC) profiling
- Evaluation of customer provided samples with our in-house research devices