Author:
Narhi Linda O.,Luo Quanzhou,Wypych Jette,Torosantucci Riccardo,Hawe Andrea,Fujimori Kiyoshi,Nashed-Samuel Yasser,Jawa Vibha,Joubert Marisa K.,Jiskoot Wim
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Reference33 articles.
1. ICH Q3D Impurities: Guideline for elemental impurities. EMA/CHMP/ICH/353369/2013. 2009.
2. ICH Q6B Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. EMA/CHMP/ICH/365/96. 1999.
3. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009;4:1201–5.
4. Joubert MK, Hokom M, Eakin C, Zhou L, Deshpande M, Baker MP, et al. Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses. J Biol Chem. 2012;30:25266–79.
5. Bi V, Jawa V, Joubert MK, Kaliyaperumal A, Eakin C, Richmond K, et al. Development of a human antibody tolerant mouse model to assess the immunogenicity risk due to aggregated biotherapeutics. J Pharm Sci. 2013;102:3545–55.
Cited by
13 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献