Due to unique production conditions during the biosynthesis of biological drugs as well as their complex nature, the final product may exhibit a variety of molecular deviations. These process- and product related impurities are not completely avoidable due to the large number of manufacturing steps and can be further increased by other influencing factors along the value chain. As the identification, control and reporting of impurities is required by regulatory agencies such as the FDA and EMA, the qualitative and quantitative examination of impurities is certainly a fundamental pillar of quality assurance during the manufacturing process of biologics and biosimilars.
Our experts at Biofidus AG know how to routinely and reliably distinguish between process- and product-related impurities and help you define appropriate acceptance criteria for your product development. According to the ICH Q6B guideline, we offer a broad range of bioanalytical packages for the purity analysis of your upstream and downstream processes in the production of peptides, antibodies, recombinant proteins and vaccines.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, 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 scientist to scientist.
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