The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.

ABSTRACT: The NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and stability testing. It must therefore embody the quality and characteristics of a typical biopharmaceutical product and be available long-term in a stable format with consistent product quality attributes. A stratified sampling and analysis plan using a series of qualified analytical and biophysical methods is described that assures RM 8671 meets these criteria. Results for the first three lots of RM 8671 highlight the consistency of material attributes with respect to size, charge, and identity. RM 8671 was verified to be homogeneous both within and betwe

SUBMITTER: Schiel JE 

PROVIDER: S-EPMC5830482 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature