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The FDA's latest guidance on peptide drugs proposes that the secondary structure needs to be characterized on the basis of the primary sequence, including characterization data such as the amino acid sequence of the impurities and the secondary structure. At present, the common methods for identifying the structure of polypeptides include crystal structure analysis, nuclear magnetic resonance analysis, and cryo-electron microscopy analysis. Among them, nuclear magnetic resonance is the most direct and effective technical method to identify the structure of the original drug solution.
Nuclear Magnetic Resonance(NMR)
Cryo-electron microscopy(Cryo-EM)
Rapid freezing and direct imaging to obtain 3D structures of a series of intact synapses in a near-physiological state
Systematic quantitative analysis
● Nuclear magnetic analysis method of peptide structure in the original drug solution
● Development of N15, C13, F19 isotopic labeling methods to resolve complex structures
● Structural Identification of Active Ingredients in the Original Liquid of Polypeptide Medicine
● Structure analysis of trace impurities
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