Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective

Author:

Zhuang Yanli,Chen Di,Sharma Amarnath,Xu Zhenhua

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference85 articles.

1. Schroeder HW Jr, Cavacini L. Structure and function of immunoglobulins. J Allergy Clin Immunol. 2010;125(2 Suppl 2):S41–52. https://doi.org/10.1016/j.jaci.2009.09.046 .

2. Woof JM, Burton DR. Human antibody-Fc receptor interactions illuminated by crystal structures. Nat Rev Immunol. 2004;4(2):89–99. https://doi.org/10.1038/nri1266 .

3. Jacobi A, Enenkel B, Garidel P, Eckermann C, Knappenberger M, Presser I, et al. Process development and manufacturing of therapeutic antibodies. In: Dübel S, Reichert JM, editors. Handbook of therapeutic antibodies. 2nd ed. Weinheim: Wiley-Blackwell; 2014. p. 603–664. https://doi.org/10.1002/9783527682423.ch22 .

4. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies—non-clinical and clinical issues. 2012. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf . Accessed June 2018.

5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. International conference on harmonization guideline Q5E: comparability of biotechnological/biological products subject to changes in their manufacturing process. 2004. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf . Accessed June 2018.

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