A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins

被引：21

作者：

Kierzek, Andrzej M. ^{[1
]}

Hickling, Timothy P. ^{[2
]}

Figueroa, Isabel ^{[3
]}

Kalvass, J. Cory ^{[3
]}

Nijsen, Marjoleen ^{[3
]}

Mohan, Krithika ^{[3
]}

Veldman, Geertruida M. ^{[3
]}

Yamada, Akihiro ^{[4
]}

Sayama, Hiroyuki ^{[5
]}

Yokoo, Sachiko ^{[5
]}

Gulati, Abhishek ^{[6
]}

Dhanikula, Renu S. ^{[7
]}

Gokemeijer, Jochem ^{[7
]}

Leil, Tarek A. ^{[7
]}

Thalhauser, Craig J. ^{[7
]}

Giorgi, Mario ^{[1
]}

Swat, Maciej J. ^{[1
]}

Chelliah, Vijayalakshmi ^{[8
]}

Small, Ben G. ^{[1
]}

Benson, Neil ^{[8
]}

Walker, Michael ^{[1
]}

Gadkar, Kapil ^{[9
]}

Quarmby, Valerie ^{[9
]}

Deng, Rong ^{[9
]}

Ferrante, Andrea ^{[10
]}

Dickinson, Gemma L. ^{[11
]}

Van Der Walt, Jan-Stefan ^{[12
]}

Zhou, Lian ^{[11
]}

Chen, Xiaoying ^{[13
]}

Jones, Hannah M. ^{[13
]}

Narula, Jatin ^{[13
]}

Tourdot, Sophie ^{[2
]}

Lave, Thierry ^{[14
]}

Ribba, Benjamin ^{[14
]}

van Der Graaf, Piet H. ^{[8
]}

机构：

[1] Certara UK Ltd, Certara QSP, Sheffield, S Yorkshire, England

[2] Pfizer, BioMed Design, Andover, MA USA

[3] AbbVie Inc, N Chicago, IL USA

[4] Astellas Pharma Inc, Clin Pharmacol & Exploratory Dev, Pharmacometr JP, Tokyo, Japan

[5] Astellas Pharma Inc, Anal & Pharmacokinet Res Labs, Tsukuba, Ibaraki, Japan

[6] Astellas Pharma Global Dev Inc, Pharmacometr Us, Clin Pharmacol & Exploratory Dev, Northbrook, IL USA

[7] Bristol Myers Squibb, Princeton, NJ USA

[8] Certara UK Ltd, Certara QSP, Canterbury, Kent, England

[9] Genentech Inc, Dev Sci, 460 Point San Bruno Blvd, San Francisco, CA 94080 USA

[10] Lilly Biotechnol Ctr, AME Biotechnol Discovery Res, San Diego, CA USA

[11] Eli Lilly & Co, Indianapolis, IN 46285 USA

[12] Eli Lilly Res & Dev, Windlesham, Surrey, England

[13] Pfizer, BioMed Design, Cambridge, MA USA

[14] Roche Innovat Ctr Basel, Pharmaceut Sci, Roche Pharmaceut Res & Early Dev, Basel, Switzerland

来源：

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2019年 / 8卷 / 11期

关键词：

D O I：

10.1002/psp4.12465

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Immunogenicity is a major challenge in drug development and patient care. Currently, most efforts are dedicated to the elimination of the unwanted immune responses through T-cell epitope prediction and protein engineering. However, because it is unlikely that this approach will lead to complete eradication of immunogenicity, we propose that quantitative systems pharmacology models should be developed to predict and manage immunogenicity. The potential impact of such a mechanistic model-based approach is precedented by applications of physiologically-based pharmacokinetics.

引用

页码：773 / 776

页数：4

共 10 条

[1] Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up [J].

Bartelds, Geertje M. ;

Krieckaert, Charlotte L. M. ;

Nurmohamed, Michael T. ;

van Schouwenburg, Pauline A. ;

Lems, Willem F. ;

Twisk, Jos W. R. ;

Dijkmans, A. C. ;

Aarden, Lucien ;

Wolbink, Gerrit Jan .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2011, 305 (14) :1460-1468

[2]

Biopharma Dive, 2018, FUT BIOL DEV INS HEL

[3] A Mechanistic, Multiscale Mathematical Model of Immunogenicity for Therapeutic Proteins: Part 1-Theoretical Model [J].

Chen, X. ;

Hickling, T. P. ;

Vicini, P. .

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2014, 3 (09)

[4] A Mechanistic, Multiscale Mathematical Model of Immunogenicity for Therapeutic Proteins: Part 2-Model Applications [J].

Chen, X. ;

Hickling, T. P. ;

Vicini, P. .

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2014, 3 (09)

[5] A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of 'Bottom-Up' vs 'Top-Down' Recognition of Covariates [J].

Jamei, Masoud ;

Dickinson, Gemma L. ;

Rostami-Hodjegan, Amin .

DRUG METABOLISM AND PHARMACOKINETICS, 2009, 24 (01) :53-75

[6]

Kothari Mansi M, 2017, World J Gastrointest Pharmacol Ther, V8, P155, DOI 10.4292/wjgpt.v8.i3.155

[7] Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective [J].

Shebley, Mohamad ;

Sandhu, Punam ;

Riedmaier, Arian Emami ;

Jamei, Masoud ;

Narayanan, Rangaraj ;

Patel, Aarti ;

Peters, Sheila Annie ;

Reddy, Venkatesh Pilla ;

Zheng, Ming ;

de Zwart, Loeckie ;

Beneton, Maud ;

Bouzom, Francois ;

Chen, Jun ;

Chen, Yuan ;

Cleary, Yumi ;

Collins, Christiane ;

Dickinson, Gemma L. ;

Djebli, Nassim ;

Einolf, Heidi J. ;

Gardner, Iain ;

Huth, Felix ;

Kazmi, Faraz ;

Khalil, Feras ;

Lin, Jing ;

Odinecs, Aleksandrs ;

Patel, Chirag ;

Rong, Haojing ;

Schuck, Edgar ;

Sharma, Pradeep ;

Wu, Shu-Pei ;

Xu, Yang ;

Yamazaki, Shinji ;

Yoshida, Kenta ;

Rowland, Malcolm .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2018, 104 (01) :88-110

[8]

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research, 2014, GUID IND IMM ASS THE

[9]

van der Graaf P.H., 2018, DEV IMMUNOGENICITY S

[10] Evaluating and Reporting the Immunogenicity Impacts for Biological Products-a Clinical Pharmacology Perspective [J].

Wang, Yow-Ming C. ;

Wang, Jie ;

Hon, Yuen Yi ;

Zhou, Lin ;

Fang, Lanyan ;

Ahn, Hae Young .

AAPS JOURNAL, 2016, 18 (02) :395-403

← 1 →