Impurity Analysis for Biologics & Biosimilars
Due to the unique production conditions and high complexity of biological drugs, the final product often contains a variety of molecular variants and impurities. These process-related and product-related impurities arise across multiple manufacturing steps and can be further influenced by storage, handling and the overall supply chain. Because identification, control and reporting of impurities are required by regulatory agencies such as FDA and EMA, qualitative and quantitative impurity analysis is a fundamental pillar of quality assurance during the development and manufacturing of biologics and biosimilars.
Our experts at Biofidus routinely distinguish between process-related impurities (e.g. host cell proteins, residual DNA, residual reagents) and product-related impurities (e.g. variants, fragments, aggregates), and help you define appropriate acceptance criteria for your product. In line with ICH Q6B, we offer a broad range of bioanalytical packages for purity and impurity analysis in upstream and downstream processes for peptides, antibodies, recombinant proteins, vaccines and other biologics.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods, tailoring them to your drug substance, its formulation matrix and your specific analytical questions, from early process development through clinical phases to commercial lifecycle management.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
