Opalescence Arising from Network Assembly in Antibody Solution.

Mol Pharm

Faculty of Pure and Applied Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8573, Ibaraki, Japan.

Published: April 2022

AI Article Synopsis

  • Opalescence in therapeutic antibody solutions poses a challenge in drug formulation due to unclear underlying mechanisms.
  • The study explored how antibody concentration affects the assembly states of bovine gamma globulin and human immunoglobulin G, revealing submicron-scale networks that caused a transparent blue opalescence without forming visible precipitates.
  • The inclusion of stabilizers like trehalose and arginine was found to reduce this opalescence, offering valuable insights for enhancing protein formulations.

Article Abstract

Opalescence of therapeutic antibody solutions is one of the concerns in drug formulation. However, the mechanistic insights into the opalescence of antibody solutions remain unclear. Here, we investigated the assembly states of antibody molecules as a function of antibody concentration. The solutions of bovine gamma globulin and human immunoglobulin G at around 100 mg/mL showed the formation of submicron-scale network assemblies. The network assembly resulted in the appearance of opalescence with a transparent blue color without the precipitates of antibodies. Furthermore, the addition of trehalose and arginine, previously known to act as protein stabilizers and protein aggregation suppressors, was able to suppress the opalescence arising from the network assembly. These results will provide an important information for evaluating and improving protein formulations.

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Source
http://dx.doi.org/10.1021/acs.molpharmaceut.1c00929DOI Listing

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