Real-time imaging of monoclonal antibody film reconstitution after mechanical stress at the air-liquid interface by Brewster angle microscopy.

Autor: Žuntar T; Faculty of Mathematics and Physics, University of Ljubljana, Jadranska 19, Ljubljana, Slovenia., Ličen M; Faculty of Mathematics and Physics, University of Ljubljana, Jadranska 19, Ljubljana, Slovenia., Kuzman D; Biologics Drug Product, Technical Research and Development, Global Drug Development, Novartis, Lek d.d., Kolodvorska 27, Mengeš, Slovenia., Osterman N; Faculty of Mathematics and Physics, University of Ljubljana, Jadranska 19, Ljubljana, Slovenia; Complex Matter Department, Jožef Stefan Institute, Jamova 39, Ljubljana, Slovenia.
Jazyk: angličtina
Zdroj: Colloids and surfaces. B, Biointerfaces [Colloids Surf B Biointerfaces] 2022 Oct; Vol. 218, pp. 112757. Date of Electronic Publication: 2022 Aug 05.
DOI: 10.1016/j.colsurfb.2022.112757
Abstrakt: Monoclonal antibodies (mAbs) represent an important part of biological pharmaceutics. A serious challenge in their development is the formation of protein particles, which are often formed through protein aggregation at the air-liquid interface and then introduced into solution by interfacial stresses. In this paper, protein films formed at the air-liquid interface by two mAbs were disrupted by puncturing them with a microscopic needle, and the subsequent reconstitution of the film was observed in real-time by Brewster angle microscopy. Our results indicate that film reconstitution pace depends on mAb bulk concentration. Numerical modeling gives a quantitative prediction of the surface reconstitution. By extrapolating the model to concentrations typical for pharmaceutical formulations (>30 mg/mL) reconstitution timescales of the protein films can be estimated to be shorter than 0.01 s. Moreover, the effect of polysorbate 80 addition on protein film was studied. Film reconstitution measurements revealed that polysorbate 80 inhibits the film reconstitution process and breaks up the previously formed film.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Natan Osterman reports financial support and equipment, drugs, or supplies were provided by Lek Pharmaceuticals. Drago Kuzman reports a relationship with Lek Pharmaceuticals that includes: employment.
(Copyright © 2022 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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