Capillary Electrophoresis (CE) Analysis
Due to the unique production conditions and complex structures of biological drugs, the final product often contains a range of molecular variants and impurities. These process-related and product-related impurities arise across multiple manufacturing steps and may be further influenced by formulation, handling and storage along the value chain.
Because identification, control and reporting of impurities are required by agencies such as FDA and EMA, the qualitative and quantitative examination of purity, size variants and charge variants is a fundamental pillar of quality assurance and CMC development for biologics and biosimilars.
Capillary electrophoresis (CE) – including CE-SDS, capillary zone electrophoresis (CZE) and icIEF, has become a key technology to resolve and quantify size and charge heterogeneity, providing high resolution, robustness and regulatory acceptance in line with ICH Q6B.
At Biofidus, our scientists routinely distinguish between process-related and product-related impurities, help you define appropriate acceptance criteria, and build fit-for-purpose CE methods for peptides, antibodies, recombinant proteins and vaccines from early development through commercial lifecycle.
In line with your needs, we adapt and, if required, qualify (according to ICH guidelines) our CE platform methods, tailoring them to your drug substance, its formulation matrix and your specific analytical questions, from process development and release testing to comparability and regulatory submissions.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist
