Emerging NMR techniques as advanced tools for characterising biological parenteral products
Posted: 20 May 2019 | Bruce Yu - University of Maryland School of Pharmacy, Wei Xu - Merck & Co, Yongchao Su - Merck & Co | No comments yet
An important step in the research and development of biopharmaceuticals is to identify molecules with favourable physical and chemical stability profiles. Yongchao Su, Wei Xu and Bruce Yu discuss how solution, solid-state and benchtop nuclear magnetic resonance (NMR) methods can provide advanced biophysical characterisations of biological products.
Large molecules can exhibit complex structural behaviours due to their flexible molecular properties. An important step in the research and development of biopharmaceuticals is to identify molecules with favourable physical and chemical stability profiles, as these attributes are critical to the efficacy and safety of a drug product.1 In parenteral formulations, the conformational flexibility of proteins can result in different intra- and intermolecular contacts and sometimes trigger physical aggregation and chemical degradation. Thermal and mechanical stress encountered during the manufacturing processes, transport and storage of the finished products often introduce additional stability risk.