Tunable equilibrium monoclonal antibody nanocluster dispersions at high concentrations
The sugar trehalose constitutes a frequently employed and compliant additive of drug formulations, including monoclonal antibody (mAb) formulations. It has been shown that trehalose can induce colloidally stable and reversible nanoclusters in mAb solutions [Borwankar et al., Soft Matter 9, 1766 (2013)]. The resulting mAb nanocluster suspensions are syringeable even at mAb concentrations of at least 200mg/ml. Here we aim to fundamentally understand the mechanism underlying the formation of these clusters by probing in particular the regime of small clusters at the transition from a monomeric system to a system containing large clusters. We will employ neutron backscattering to determine the hydrodynamic size of these clusters unambiguously via their self-diffusion and to simultaneously obtain new information on the mAb internal dynamics. Additionally, we will employ SANS to characterize the time-averaged structure of the clusters up to the scale of at least 50nm. This research being part of an InnovaXN PhD project, we have already embarked on successful experiments employing mAbs by Lonza AG using Rheology, DLS, SAXS (ID02, exp.MD-1284), and a test on BATS.
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COLIN Louise; BECK Christian; BUCHHOLZ Cara; GRAPENTIN Christoph; MATSARSKAIA Olga; MOSCA Ilaria; POUNOT Kevin; REICHART Lara; Frank Schreiber and SEYDEL Tilo. (2021). Tunable equilibrium monoclonal antibody nanocluster dispersions at high concentrations. Institut Laue-Langevin (ILL) doi:10.5291/ILL-DATA.8-04-923
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