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Biosimilar Analysis Workflows
Easily establish structure of biosimilar drugs
In the US, biopharmaceutical innovators have 12 years of patent protection for biologic medicines, at which point it becomes possible for biosimilar and biobetter sponsors to market similar therapeutic protein products.
The FDA has published the scientific consideration for demonstrating biosimilarity to a reference product, which provides insight how they will evaluate biosimilar biological products.
In order to establish the biosimilarity of a therapeutic drug candidate to the original innovator molecule, both proteins must be exhaustively structurally characterized for a number of criteria—all covered in International Council for Harmonization guidelines ICH Q5E and ICH Q6B.
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Biosimilar analysis workflow categories
Thermo Fisher Scientific has proven workflows and capabilities to support all recommended protein structural analyses for biosimilar development:
| Critical quality attribute | Solution |
|---|---|
| Primary amino acid sequence | Our new, robust peptide mapping workflow gives you 100% sequence coverage. |
| Protein variation | Simple, standardized peptide mapping can be used to easily monitor for protein deamidation and oxidation. |
| Glycosylation post translational modifications | Determine modifications to amino acids with sugar moieties (glycosylation) with our advanced workflows for intact glycoforms, released glycans, glycopeptides, monosaccharides, and sialic acids. |
| Protein heterogeneity | Find our range of buffers, column chemistries, and UHPLC instrumentation to meet the needs for robust charge variant profiling of biopharmaceuticals. |
| Process and product-related impurities | Easily discover the identity and quantity of host cell proteins with our HCP analysis workflow. |
| Protein aggregation | Get the latest innovations in size exclusion chromatography (SEC) for high-resolution separation of monoclonal antibodies (mAb) and their aggregates. |
| Higher order structure | Discover how Orbitrap-based mass spectrometry can enable insight into protein folding and protein-protein interactions. |
| Intentional chemical modifications | Learn how to effectively monitor PEGylation sites and characteristics. |
Biosimilar analysis products
BioPharma Finder software has advanced comparability features for biosimilar studies
Save time with structural biosimilarity studies
BioPharma Finder integrated software is a complete solution for intact protein characterization and peptide mapping.
Featured biosimilar analysis content
A key step to proving biosimilarity is to establish glycosylation patterns, because variations in glycosylation can affect the efficacy and safety of therapeutic proteins, influencing their biological activity, serum half-life, and immunogenicity. Monosaccharides, including sialic acid composition analysis can detect variations in glycosylation, and support quality control for process development and manufacturing procedures. As a result, proteins are routinely analyzed to determine their monosaccharides and sialic acids amount and identity.
Featured videos
A universal chromatography method for aggregate analysis of monoclonal antibodiesNIBRT Application note overview on protein aggregation analysis of five important biotherapeutic monoclonal antibodies by size-exclusion chromatography
Importance of UHPLC instrument setup for protein aggregate analysis by size-exclusion chromatographyNIBRT Application note overview demonstrating the applicability of MAbPac™ SEC-1 columns and Vanquish UHPLC for monoclonal antibody aggregate analysis
High-precision, automated peptide mapping of proteinsNIBRT Application note overview detailing development of a robust and reproducible, high-precision, automated, peptide mapping workflow for LC and LC-MS
Using the NISTmAb reference standard to demonstrate a simple approach to charge variant analysisNIBRT Application note overview of a simple pH gradient/IEX chromatography workflow for characterization of charge variants in monoclonal antibodies
Comprehensive glycosylation comparison of innovator and candidate biosimilar mAbs via HILIC UHPLCNIBRT Application note overview of a fast, HILIC UHPLC-HRAM MS approach to glycan profiling of 2-AA labelled candidate biosimilar and innovator mAbs
Fast profiling N-glycans in biotherapeutic antibodies by UHPLC-FLD with MS confirmationNIBRT Application note overview of an UHPLC-HRAM MS approach to fast, comprehensive profiling of 2-AA and 2-AB labeled glycans in IgG antibodies
Ultrafast, batch-to-batch comparison of monoclonal antibody glycosylationNIBRT Application note overview of high-throughput biosimilar glycan analysis- 20 X lower separation time and excellent batch-to-batch reproducibility
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