Analytical techniques for structural characterization of proteins in solid pharmaceutical forms : an overview

Bolje, Aljoša (avtor), Gobec, Stanislav (avtor)

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.

• Jezik: Angleški jezik
• Ključne besede: solid pharmaceuticals, lyophilization, analytical tools, protein characterization, protein structure, formulation development, antibody, excipients, stable drug product, safe drug
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.02 - Pregledni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2021
• Št. strani: 32 str.
• Številčenje: Vol. 13, iss. 4, art. 534
• PID: 20.500.12556/RUL-135221
• UDK: 66.047.3:615.45
• ISSN pri članku: 1999-4923
• DOI: 10.3390/pharmaceutics13040534
• COBISS.SI-ID: 60765443
• Datum objave v RUL: 01.03.2022

Gradivo je del revije

• Naslov: Pharmaceutics
• Skrajšan naslov: Pharmaceutics
• Založnik: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
• Začetek licenciranja: 11.04.2021

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: sušenje z zamrzovanjem, zgradba proteinov, stabilnost zdravil, pomožne snovi, terapevtske beljakovine, protitelesa, farmacevtske oblike

Projekti

• Financer: Drugi - Drug financer ali več financerjev
• Program financ.: Republic of Slovenia, Ministry of Education, Science, and Sport
• Številka projekta: 5442-1/2018/405

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P1-0208
• Naslov: Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin