20.500.12556/RUL-135221 Analytical techniques for structural characterization of proteins in solid pharmaceutical forms an overview Therapeutic proteins as biopharmaceuticals have emerged as a very important class of drugs for the treatment of many diseases. However, they are less stable compared to conventional pharmaceuticals. Their long-term stability in solid forms, which is critical for product performance, depends heavily on the retention of the native protein structure during the lyophilization (freeze-drying) process and, thereafter, in the solid state. Indeed, the biological function of proteins is directly related to the tertiary and secondary structure. Besides physical stability and biological activity, conformational stability (three-dimensional structure) is another important aspect when dealing with protein pharmaceuticals. Moreover, denaturation as loss of higher order structure is often a precursor to aggregation or chemical instability. Careful study of the physical and chemical properties of proteins in the dried state is therefore critical during biopharmaceutical drug development to deliver a final drug product with built-in quality that is safe, high-quality, efficient, and affordable for patients. This review provides an overview of common analytical techniques suitable for characterizing pharmaceutical protein powders, providing structural, and conformational information, as well as insights into dynamics. Such information can be very useful in formulation development, where selecting the best formulation for the drug can be quite a challenge. solid pharmaceuticals lyophilization analytical tools protein characterization protein structure formulation development antibody excipients stable drug product safe drug sušenje z zamrzovanjem zgradba proteinov stabilnost zdravil pomožne snovi terapevtske beljakovine protitelesa farmacevtske oblike true false true Angleški jezik Slovenski jezik Članek v reviji 2022-03-01 13:17:45 2022-03-01 13:17:49 2022-09-14 04:12:15 0000-00-00 00:00:00 2021 0 0 32 str. iss. 4, art. 534 Vol. 13 2021 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 66.047.3:615.45 1999-4923 10.3390/pharmaceutics13040534 60765443 RAZ_Bolje_Aljosa_2021.pdf RAZ_Bolje_Aljosa_2021.pdf 1 26776B880FA432A1852D2C5B88BD3310 8e5a6a13097acfa082119981ed2485b124156d5cfa84d434911fda47fb732e19 a4b44272-9959-11ec-abdb-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=154150 https://www.mdpi.com/1999-4923/13/4/534 1 582a70ff-9959-11ec-abdb-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=154149 Fakulteta za farmacijo 0 0 0