From Bio-Development Services - Process Development
Bioactivity of final products is a key feature in the specification of biopharmaceutical drug substances and clinical samples. Therefore, choosing the right partner for bioactivity and technically challenging cell-based assays is crucial. Consistent assay performance requires a controlled setting, highly skilled analysts with a deep understanding of cell physiology and well-developed and characterized methods. Successful development of such assays requires expertise – and that only comes with experience.
Celonic is your dedicated expert partner for all aspects of bioassay development, validation, method transfer and long-term assay maintenance. We have broad experience in GCLP assay development at Celonic and a proven track record in establishing qualified and validated methods for product quality control. For decades, we have successfully applied our know-how, proficiency and expertise in immunology and routine assays. With our broad experience, we stand for quality completion of your testing program.
We Specialize In:
- Specific binding assays
- FcgRIIIa binding assays
- Antibody-dependent cell-mediated cytotoxicity (ADCC)
- Cell proliferation assays, cell based potency assays for rhGH, G-CSF and GM-CSF
- Custom-made NK cell cytotoxicity assays
- Custom-made lymphocyte proliferation assays
- Evaluation of customer-provided samples
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