Literature DB >> 24623189

Impact of residual impurities and contaminants on protein stability.

Wei Wang1, Arun Alphonse Ignatius, Santosh V Thakkar.   

Abstract

Production of recombinant proteins generates a variety of process-related impurities. The multistep manufacturing processes may introduce many potential contaminants into the final pharmaceutical products. These residual impurities and contaminants can potentially impact the protein stability significantly. In this short review, the authors intend to discuss major sources and types of residual process-related impurities and potential product contaminants, their impact on protein quality/stability, and possible mitigations during product development and manufacturing processes.
© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Keywords:  biotechnology; deamidation; formulation; oxidation; protein aggregation

Mesh：

Substances：

Year:  2014        PMID： 24623189     DOI： 10.1002/jps.23931

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN： 0022-3549            Impact factor:   3.534


  8 in total

1.  Evaluation of thermal stability of confectionary sunflower protein isolate and its effect on nanoparticulation and particle size of the produced nanoparticles.

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Journal:  Food Sci Biotechnol       Date:  2017-06-29       Impact factor: 2.391

2.  Comparative Evaluation of the Chemical Stability of 4 Well-Defined Immunoglobulin G1-Fc Glycoforms.

Authors:  Olivier Mozziconacci; Solomon Okbazghi; Apurva S More; David B Volkin; Thomas Tolbert; Christian Schöneich
Journal:  J Pharm Sci       Date:  2016-01-11       Impact factor: 3.534

3.  Comparative Effects of Metal-Catalyzed Oxidizing Systems on Carbonylation and Integrity of Therapeutic Proteins.

Authors:  Dmitry Kryndushkin; V Ashutosh Rao
Journal:  Pharm Res       Date:  2015-10-23       Impact factor: 4.200

4.  Lyophilization Serves as an Effective Strategy for Drug Development of the α9α10 Nicotinic Acetylcholine Receptor Antagonist α-Conotoxin GeXIVA[1,2].

Authors:  Zhiguo Li; Xiaolu Han; Xiaoxuan Hong; Xianfu Li; Jing Gao; Hui Zhang; Aiping Zheng
Journal:  Mar Drugs       Date:  2021-02-25       Impact factor: 5.118

5.  Safety risk management for low molecular weight process-related impurities in monoclonal antibody therapeutics: Categorization, risk assessment, testing strategy, and process development with leveraging clearance potential.

Authors:  Haibin Luo; Yuling Li; David Robbins; Sheau-Chiann Wang; Guoling Xi; Matthew Cox; Simone M Nicholson; Chenghong Wei; Timothy M Pabst; William K Wang
Journal:  Biotechnol Prog       Date:  2021-01-06

6.  Physical-chemical and biological characterization of different preparations of equine chorionic gonadotropin.

Authors:  Rafael Herrera Alvarez; Fabio Luis Nogueira Natal; Maria Teresa Carvalho Pinto Ribela; Beatriz Elane de Almeida; João Ezequiel de Oliveira; Paolo Bartolini
Journal:  J Vet Sci       Date:  2016-12-30       Impact factor: 1.672

7.  Comprehensive characterisation of the heterogeneity of adalimumab via charge variant analysis hyphenated on-line to native high resolution Orbitrap mass spectrometry.

Authors:  Florian Füssl; Anne Trappe; Ken Cook; Kai Scheffler; Oliver Fitzgerald; Jonathan Bones
Journal:  MAbs       Date:  2018-11-11       Impact factor: 5.857

8.  Understanding the formation and behaviors of droplets toward consideration of changeover during cell manufacturing.

Authors:  Yuuki Ogawa; Manabu Mizutani; Ryuta Okamoto; Hideki Kitajima; Sachiko Ezoe; Masahiro Kino-Oka
Journal:  Regen Ther       Date:  2019-04-25       Impact factor: 3.419
  8 in total

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