Bolje, Aljoša (2021) Project report (for Faculty of Pharmacy): Structural characterization of proteins in solid pharmaceutical forms. Project report published on the Faculty of Pharmacy's web page.

Abstract

We started the projected studies by preparing samples, i.e. lyophilizates. We decide to use two different monoclonal antibodies and several different excipients, among them two sugars as stabilizing agents. We employed different lyophilization cycles, one for mAb1 and two for mAb2. Some of the samples of monclonal antibody mAb2 were later subjected to stability studies at 40ºC for three and nine months. For samples of mAb1 we used also different stresses, such as UV light and temperature. Samples were analyzed by spectroscopic methods (Infrared, UV-Vis, Fluorescence and Raman spectroscopy, and solid-state NMR), Circular dichroism, Dynamic differential calorimetry, X-ray diffraction analysis and others. Samples with monoclonal antibody mAb1 have shown to be relatively stable, except when exposed to higher temperatures. Within samples of mAb2 we observed less secondary and tertiary structure for samples that were subjected to stability studies. Later we decide also to analyze sample for aggregates formation, which is already a part of the projected studies implementation within Lek d.d.. As an important part of this project we also take care of the dissemination by participating on several lectures, conferences and other activities. We are in the final process of publishing a review that covers the literature of the projected studies.

Item Type:	Article
Date Deposited:	16 Nov 2021 00:45
Last Modified:	16 Nov 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44186