Comprehensive Assessment of Protein and Excipient Stability in Biopharmaceutical Formulations Using ¹H NMR Spectroscopy.

ABSTRACT: Biopharmaceutical proteins are important drug therapies in the treatment of a range of diseases. Proteins, such as antibodies (Abs) and peptides, are prone to chemical and physical degradation, particularly at the high concentrations currently sought for subcutaneous injections, and so formulation conditions, including buffers and excipients, must be optimized to minimize such instabilities. Therefore, both the protein and small molecule content of biopharmaceutical formulations and their stability are critical to a treatment's success. However, assessing all aspects of protein and small molecule stability currently requires a large number of analytical techniques, most of which involve sample dilution or other manipulations which may themselves distort sample behavior. Here, we demonstrat

SUBMITTER: Bramham JE 

PROVIDER: S-EPMC7906489 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature