Higher Order Structure (HOS)

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Definition

HOS is responsible for the correct folding and three-dimensional shape of a biopharmaceutical. This can be affected by different formulations, which in turn can affect protein activity. If the overall shape of a protein is wrong, receptor binding can be inhibited, immunogenic epitopes can be exposed and aggregation can occur. It is therefore crucial to employ a thorough characterization of the higher order structure of the protein.

Related Content & Resources

Knowledge Center

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Case Study

Intas Pharmaceuticals Ltd.- Structural Characterization of PEG-GCSF Using Nuclear Magnetic Resonance (NMR)

ICH Topic Q6B includes the use of NMR as a tool for understanding higher order structure. Here, BioPharmaSpec characterizes several samples of PEG-GCSF using 1-Dimensional (1D) 1H-NMR and 2-Dimensional (2D) 1H/13C-NMR at 800MHz.