Evaluation and Screening of Biopharmaceuticals using Multi-Angle Dynamic Light Scattering.

ABSTRACT: Biopharmaceuticals are large, complex and labile therapeutic molecules prone to instability due to various factors during manufacturing. To ensure their safety, quality and efficacy, a wide range of critical quality attributes (CQAs) such as product concentration, aggregation, particle size, purity and turbidity have to be met. Size exclusion chromatography (SEC) is the gold standard to measure protein aggregation and degradation. However, other techniques such as dynamic light scattering (DLS) are employed in tandem to measure the particle size distribution (PSD) and polydispersity of biopharmaceutical formulations. In this study, the application of multi-angle dynamic light scattering (MADLS) was evaluated for the determination of particle size, particle concentration and aggregation in

SUBMITTER: Sharma A 

PROVIDER: S-EPMC10033178 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature