Biosimilar Characterization
Biosimilar characterization involves a thorough and systematic analysis of the physicochemical properties, structural features, functional activity, and safety profiles of biosimilars. This ensures they are highly similar to their reference biologics in terms of quality, safety, and efficacy. Biosimilars, which include complex proteins like monoclonal antibodies, fusion proteins, and recombinant proteins, require meticulous production involving cell cultures and protein purification. Even minor changes in the manufacturing process can alter the protein's structure and function. Therefore, rigorous biosimilar characterization is essential during development to ensure quality consistency with the reference drug and to comply with the approval standards of regulatory bodies. The primary purpose of this characterization is to establish comparability with the reference product, supporting regulatory approval and market entry. Biosimilar characterization is applied in various fields, including pharmaceutical research, quality control, process optimization, and preclinical evaluation. Techniques like high-resolution mass spectrometry, chromatography, peptide mapping, and bioactivity assays are used to analyze the primary structure, post-translational modifications (e.g., glycosylation, oxidation, deamidation), higher-order structures (secondary and tertiary), aggregation states, and functional attributes of biosimilars. This ensures they align with the original biologic's critical quality attributes. Additionally, biosimilar characterization assesses stability, degradation pathways, and immunogenicity risk, aiding process optimization and enhancing product consistency and safety.
Structural characterization is a crucial component of biosimilar characterization. Primary structure analysis identifies protein amino acid sequences and evaluates post-translational modifications using high-resolution mass spectrometry and liquid chromatography. Secondary structures are assessed with circular dichroism and Fourier-transform infrared spectroscopy, confirming protein folding. Tertiary structure analysis utilizes hydrogen-deuterium exchange mass spectrometry and nuclear magnetic resonance to study conformational changes. Moreover, the aggregation state of proteins, which significantly impacts drug safety and efficacy, is monitored using dynamic light scattering and size-exclusion chromatography.
In addition to structural analysis, biosimilar characterization encompasses bioactivity and functional assays. Bioactivity, a key measure of biosimilar efficacy, is evaluated through cell-based functional tests (e.g., cell proliferation inhibition, antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity) and in vitro receptor binding assays. As biosimilars can degrade or aggregate during storage and transport, impacting stability, forced degradation tests, thermal stability studies, and photodegradation tests are integral to biosimilar characterization.
MtoZ Biolabs utilizes advanced analytical platforms and extensive proteomics expertise to offer high-quality biopharmaceutical analysis services, providing comprehensive solutions from structural and post-translational modification analysis to functional assays.
MtoZ Biolabs, an integrated chromatography and mass spectrometry (MS) services provider.
Related Services
How to order?
