Combined dynamic light scattering and Raman spectroscopy approach for characterizing the aggregation of therapeutic proteins.

ABSTRACT: Determination of the physicochemical properties of protein therapeutics and their aggregates is critical for developing formulations that enhance product efficacy, stability, safety and manufacturability. Analytical challenges are compounded for materials: (1) that are formulated at high concentration, (2) that are formulated with a variety of excipients, and (3) that are available only in small volumes. In this article, a new instrument is described that measures protein secondary and tertiary structure, as well as molecular size, over a range of concentrations and formulation conditions of low volume samples. Specifically, characterization of colloidal and conformational stability is obtained through a combination of two well-established analytical techniques: dynamic light scattering (D

SUBMITTER: Lewis EN 

PROVIDER: S-EPMC6271152 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature