Distribution of Protein Content and Number of Aggregates in Monoclonal Antibody Formulation After Large-Scale Freezing.

ABSTRACT: Cryoconcentration of an in-house IgG₁ and number of aggregates in a formulation containing trehalose were determined in dependence on freezing protocol and volume. Morphology changes of ice crystals depending on cooling rates were captured by optical cryomicroscopy (OCM) images. UV-Vis and affinity chromatography (ALC) was used to determine protein content and size-exclusion chromatography (SEC) for detection of aggregates. Cooling to - 80°C rather than - 20°C is beneficial in avoiding hot spots of high protein concentration. An upscaling of 250 ml to 2 L bottles results in an up to fourfold increase of macroscopic cryoconcentration. There is no direct correlation between number of aggregates and macroscopic cryoconcentration. Aggregate formation of that specific mAb is not caus

SUBMITTER: Hauptmann A 

PROVIDER: S-EPMC6373418 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature