A successful development of new biologics and biosimilars is characterized above all by concentrated and professionally tackled study planning in order to identify the most promising candidates from many possible drug candidates or clones and to back the right horse right from the start of a project. This difficult and highly complex task requires a lot of experience and the ability to grasp multiple research results in detail and to assess the impact on the project goal appropriately.
We at Biofidus are well experienced with the whole set of necessary study types in order to meet appropriate acceptance criteria for a successful approval of your active pharmaceutical ingredient (API) by regulatory agencies such as FDA or EMA. From high-throughput developability over forced degradation to holistic comparability studies, with our assessment, we provide a bridge between product knowledge and process understanding.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance, its individual formulation matrix and your distinct analytical question.
Get in contact with us to find the optimal strategy for your project and to speak directly from expert to expert.
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