Observation of small cluster formation in concentrated monoclonal antibody solutions and its implications to solution viscosity.

ABSTRACT: Monoclonal antibodies (mAbs) are a major class of biopharmaceuticals. It is hypothesized that some concentrated mAb solutions exhibit formation of a solution phase consisting of reversibly self-associated aggregates (or reversible clusters), which is speculated to be responsible for their distinct solution properties. Here, we report direct observation of reversible clusters in concentrated solutions of mAbs using neutron spin echo. Specifically, a stable mAb solution is studied across a transition from dispersed monomers in dilute solution to clustered states at more concentrated conditions, where clusters of a preferred size are observed. Once mAb clusters have formed, their size, in contrast to that observed in typical globular protein solutions, is observed to remain nearly constant ov

SUBMITTER: Yearley EJ 

PROVIDER: S-EPMC4008822 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature