Analytical Characterization of Biologics and Biosimilars
Biologics and their biosimilars comprise the cutting-edge of biopharmaceutical products such as antibody–drug conjugates (ADCs), multispecifics, nanobodies, peptides, fusion proteins, vector based therapies used to treat complex conditions including cancer, neurologic and autoimmune disorders, and diabetes.
Biologics are far from easy to characterize, as they are highly complex, heterogeneous molecules produced by living cell systems.
Compared to small molecule drugs, biologics require significantly more integrated structure, function, purity and stability testing to ensure quality, safety and efficacy during development, technology transfer and life cycle changes. This makes specialized analytical services for biologics and biosimilars a critical success factor in modern drug development.
At Biofidus, we offer end-to-end analytical services for biologics and biosimilars, covering structural and functional characterization, critical quality attribute (CQA) assessment, impurity profiling (product- and process-related impurities, e.g., HCPs) as well as stability and forced degradation studies, comparability and biosimilarity assessments, and developability support. Using advanced mass spectrometry, chromatography, electrophoresis and bioassays, we design fit-for-purpose analytical packages for modalities such as ADCs, multispecific antibodies, IgGs, nanobodies, fusion proteins and vector-based therapeutics.
Our experience from hundreds of projects with small to large biotech and pharma companies enables us to build ICH-aligned, regulator-ready analytical strategies tailored to your drug substance (DS), its formulation matrix and your specific analytical and regulatory questions.
Get in contact with us to define the optimal analytical strategy for your biologic or biosimilar and to speak directly from expert to expert.
