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Primary Structure

A critical step in establishing and maintaining the quality, safety and efficacy of any protein biologic is the effective characterization of its primary structure.
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Primary structure considerations

The primary structure includes the amino acid sequence and Post-Translational Modifications (PTMs), both of which are vital for understanding the therapeutic’s functional properties and maintaining consistency throughout development and manufacturing. Thorough characterization is essential for meeting regulatory requirements, understanding structure-function relationships and supporting reproducibility in production.

Intact and subunit LC-MS

Molecular weight confirmation, assessment of heterogeneity and relative quantification of post-translational modifications, including glycosylation profiles

 

Reduced peptide mapping by LC-MS

Sequence verification, localization and relative quantification of post-translational modifications 

Released N-glycan analysis by LC-MS

In-depth N-glycan characterization and separating the Fc and receptor of a fusion protein for localized glycan profiling 

Capillary electrophoresis (CE) (reduced and non-reduced)

 Assessing protein size, purity and heterogeneity, as well as separating and quantifying subunits and evaluating intact proteins and aggregates

Capillary isoelectric focusing (cIEF)

Determination of the isoelectric point and charge variants for precise characterization of heterogeneity

Amino acid analysis

Confirm amino acid composition for protein purity and integrity to support sequence verification, stoichiometry assessment and batch consistency evaluations

With Labcorp, you receive a comprehensive characterization package beginning with primary structure characterization using a range of in-house platform methods. These off-the-shelf methods can either be applied immediately for rapid results or tailored to fit the specific needs of your product.

Resources

Info Sheet

Setting the foundation of success in your drug development

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