Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics-Reference-Cited by-同舟云学术

Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics

Published:2016-07-22 Issue:6 Volume:18 Page:1439-1452
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Jawa Vibha^ORCID,Joubert Marisa K.,Zhang Qingchun,Deshpande Meghana,Hapuarachchi Suminda,Hall Michael P.,Flynn Gregory C.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-016-9948-4.pdf

Reference37 articles.

1. Bracewell DG, Francis R, Smales CM. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control. Biotechnol Bioeng. 2015;112(9):1727–37.

2. de Zafra CL, Quarmby V, Francissen K, Vanderlaan M, Zhu-Shimoni J. Host cell proteins in biotechnology-derived products: A risk assessment framework. Biotechnol Bioeng. 2015;112(11):2284–91.

3. ICH (1999) ICH Harmonized Tripartite Guideline. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q6B.

4. Verthelyi D, Wang V. Trace levels of innate immune response modulating impurities (IIRMIs) synergize to break tolerance to therapeutic proteins. PLoS One. 2010;5(12), e15252.

5. Haile LA, Puig M, Kelley-Baker L, Verthelyi D. Detection of innate immune response modulating impurities in therapeutic proteins. PLoS One. 2015;10(4), e0125078.

Cited by 64 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

1. Improved clearance of host cell protein impurities at the polishing purification step using multimodal chromatography;Journal of Chromatography A;2024-09

2. Developability considerations for bispecific and multispecific antibodies;mAbs;2024-08-27

3. Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product;Journal of Pharmaceutical Sciences;2024-08

4. Recombinant Adeno-Associated Virus Vectors for Gene Therapy of the Central Nervous System: Delivery Routes and Clinical Aspects;Biomedicines;2024-07-09

5. Preparation and characterization of a novel humanized collagen III with repeated fragments of Gly300-Asp329;Protein Expression and Purification;2024-07