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 attributeSolution
Primary amino acid sequenceOur new, robust peptide mapping workflow gives you 100% sequence coverage.
Protein variationSimple, standardized peptide mapping can be used to easily monitor for protein deamidation and oxidation.
Glycosylation post translational modificationsDetermine modifications to amino acids with sugar moieties (glycosylation) with our advanced workflows for intact glycoforms, released glycans, glycopeptides, monosaccharides, and sialic acids.
Protein heterogeneityFind our range of buffers, column chemistries, and UHPLC instrumentation to meet the needs for robust charge variant profiling of biopharmaceuticals.
Process and product-related impuritiesEasily discover the identity and quantity of host cell proteins with our HCP analysis workflow.
Protein aggregationGet the latest innovations in size exclusion chromatography (SEC) for high-resolution separation of monoclonal antibodies (mAb) and their aggregates.
Higher order structureDiscover how Orbitrap-based mass spectrometry can enable insight into protein folding and protein-protein interactions.
    Intentional chemical modificationsLearn how to effectively monitor PEGylation sites and characteristics.

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