Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins

Maintaining the structure of protein and peptide drugs has become one of the most important goals of scientists in recent decades. Cold and thermal denaturation conditions, lyophilization and freeze drying, different pH conditions, concentrations, ionic strength, environmental agitation, the interac...

Full description

Bibliographic Details
Main Authors: Mohsen Akbarian, Shu-Hui Chen
Format: Article
Language:English
Published: MDPI AG 2022-11-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/14/11/2533
_version_ 1797464219101167616
author Mohsen Akbarian
Shu-Hui Chen
author_facet Mohsen Akbarian
Shu-Hui Chen
author_sort Mohsen Akbarian
collection DOAJ
description Maintaining the structure of protein and peptide drugs has become one of the most important goals of scientists in recent decades. Cold and thermal denaturation conditions, lyophilization and freeze drying, different pH conditions, concentrations, ionic strength, environmental agitation, the interaction between the surface of liquid and air as well as liquid and solid, and even the architectural structure of storage containers are among the factors that affect the stability of these therapeutic biomacromolecules. The use of genetic engineering, side-directed mutagenesis, fusion strategies, solvent engineering, the addition of various preservatives, surfactants, and additives are some of the solutions to overcome these problems. This article will discuss the types of stress that lead to instabilities of different proteins used in pharmaceutics including regulatory proteins, antibodies, and antibody-drug conjugates, and then all the methods for fighting these stresses will be reviewed. New and existing analytical methods that are used to detect the instabilities, mainly changes in their primary and higher order structures, are briefly summarized.
first_indexed 2024-03-09T18:03:55Z
format Article
id doaj.art-547186994d644917a87187fc9c275d70
institution Directory Open Access Journal
issn 1999-4923
language English
last_indexed 2024-03-09T18:03:55Z
publishDate 2022-11-01
publisher MDPI AG
record_format Article
series Pharmaceutics
spelling doaj.art-547186994d644917a87187fc9c275d702023-11-24T09:37:21ZengMDPI AGPharmaceutics1999-49232022-11-011411253310.3390/pharmaceutics14112533Instability Challenges and Stabilization Strategies of Pharmaceutical ProteinsMohsen Akbarian0Shu-Hui Chen1Department of Chemistry, National Cheng Kung University, Tainan 701, TaiwanDepartment of Chemistry, National Cheng Kung University, Tainan 701, TaiwanMaintaining the structure of protein and peptide drugs has become one of the most important goals of scientists in recent decades. Cold and thermal denaturation conditions, lyophilization and freeze drying, different pH conditions, concentrations, ionic strength, environmental agitation, the interaction between the surface of liquid and air as well as liquid and solid, and even the architectural structure of storage containers are among the factors that affect the stability of these therapeutic biomacromolecules. The use of genetic engineering, side-directed mutagenesis, fusion strategies, solvent engineering, the addition of various preservatives, surfactants, and additives are some of the solutions to overcome these problems. This article will discuss the types of stress that lead to instabilities of different proteins used in pharmaceutics including regulatory proteins, antibodies, and antibody-drug conjugates, and then all the methods for fighting these stresses will be reviewed. New and existing analytical methods that are used to detect the instabilities, mainly changes in their primary and higher order structures, are briefly summarized.https://www.mdpi.com/1999-4923/14/11/2533protein drugsantibody drugsantibody drug conjugatespharmaceutical proteins and peptidesstabilizationdenaturing stresses
spellingShingle Mohsen Akbarian
Shu-Hui Chen
Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
Pharmaceutics
protein drugs
antibody drugs
antibody drug conjugates
pharmaceutical proteins and peptides
stabilization
denaturing stresses
title Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
title_full Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
title_fullStr Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
title_full_unstemmed Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
title_short Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins
title_sort instability challenges and stabilization strategies of pharmaceutical proteins
topic protein drugs
antibody drugs
antibody drug conjugates
pharmaceutical proteins and peptides
stabilization
denaturing stresses
url https://www.mdpi.com/1999-4923/14/11/2533
work_keys_str_mv AT mohsenakbarian instabilitychallengesandstabilizationstrategiesofpharmaceuticalproteins
AT shuhuichen instabilitychallengesandstabilizationstrategiesofpharmaceuticalproteins