Biosimilars are highly similar to the reference product, with no clinically relevant differences in terms of purity, potency, and safety. And biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. However, biosimilars may be sensitive to tiny changes in manufacturing processes because of their high molecular complexity. Before the animal and clinical trials, biosimilars need to be characterized according to the guidance document ICH Q6B, which provides a uniform set of internationally accepted specifications for the characterization of biological and biotechnological products for approval.
Biosimilar Analysis Solution at Creative Proteomics
Based on years of experience to support the development of biosimilars, Creative Proteomics can provide comprehensive services, including but not limited to:
- Characterization of protein biosimilar
Creative Proteomics can provide a range of information for characterization of protein biosimilars according to the guidance document ICH Q6B, such as structural characterization, physicochemical properties, process- & product-related impurities, etc. - Comparison of biosimilars and protein therapeutic
Creative Proteomics can provide a number of physicochemical and biological methods for comprehensive comparison between the biosimilar and the original biologic using multiple analytical methods, such as intact mass analysis by liquid chromatography–mass spectrometry (LC-MS), size exclusion chromatography (SEC), ion exchange chromatography (IEC), etc. - Different biosimilars analyses
Creative Proteomics has developed a suite of off-the-shelf assay packages to support biosimilar comparability and characterization to complete similarity studies for a range of biosimilar molecules.
High-resolution molecular weight analysis
Peptide identification analysis
Peptide sequencing
- N-terminal sequence analysis
- C-terminal sequence analysis
- Sequence coverage
- HPLC peptide mapping
Purity and impurities analysis
- Residual organic solvent determination per USP <467>
- Purity/Potency assessment by HPLC
- Host cell protein analysis
- Purity assessment by capillary electrophoresis (CE, CGE, cIEF)
Our Advantages
- Creative Proteomics has set up an analysis program and reliable analytical methods for biosimilar analysis in accordance with ICH Q6B guidelines.
- We have experienced technicians and advanced equipment to provide high quality analysis services and deliver detailed reports.
- Our analysis program can combine with other techniques of our expertise in the field, so the professional analysis of biosimilars can be easily obtained.
At Creative Proteomics, we have years of experience of studying for a range of biosimilar molecules and integrated services to support biosimilar development. We also continually develop new methods to support biosimilar characterization and comparability. We are glad to discuss your special requirements and the details of the experiments to provide an optimized and customized analytical support for your comparative characterization of the biosimilar and innovator. If you have any questions or specific requirements, please feel free to contact us.
Reference
- Sorensen M, et al. Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry. mAbs. 2016, 8 (7), 1224-1234.
