Comprehensive Studies for New Biological Entities and Biosimilars
Find your best candidates faster. Our end-to-end study design for NBEs and biosimilars spans lead & clone selection, developability, comparability, biosimilarity, and stability assessments.
Tough, complex studies demand deep experience and clear judgment. At Biofidus, we run the full suite, from high-throughput developability and forced-degradation studies to holistic comparability studies, bridging product knowledge and process understanding to generate robust, regulator-ready data aligned with FDA/EMA expectations and to support confident decisions against predefined acceptance criteria.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to find the optimal strategy for your project and to speak directly from expert to expert.
