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1

Kinetic Modeling of Methionine Oxidation in Monoclonal Antibodies from Hydrogen Peroxide Spiking Studies.

Hui A, Lam XM, Kuehl C, Grauschopf U, Wang YJ. Hui A, et al. PDA J Pharm Sci Technol. 2015 Jul-Aug;69(4):511-25. doi: 10.5731/pdajpst.2015.01059. PDA J Pharm Sci Technol. 2015. PMID: 26242787

2

Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product-Hydrogen Peroxide Uptake and Impact on Protein Quality.

Hubbard A, Roedl T, Hui A, Knueppel S, Eppler K, Lehnert S, Maa YF. Hubbard A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):348-366. doi: 10.5731/pdajpst.2017.008326. Epub 2018 Mar 15. PDA J Pharm Sci Technol. 2018. PMID: 29545321

3

Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process.

Eisner DR, Hubbard A, Eppler K, Tegoulia V, Maa YF. Eisner DR, et al. PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):443-458. doi: 10.5731/pdajpst.2019.009928. Epub 2019 Apr 19. PDA J Pharm Sci Technol. 2019. PMID: 31004039

4

A Model of Prefilled Syringes Exposure to Vapor Phase Hydrogen Peroxide (VPHP).

Downey D, McGarvey B, Walsh M, Engle J. Downey D, et al. PDA J Pharm Sci Technol. 2020 Jan-Feb;74(1):73-89. doi: 10.5731/pdajpst.2018.009431. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2020. PMID: 31420501

5

Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study.

Eisner DR, Hui A, Eppler K, Tegoulia V, Maa YF. Eisner DR, et al. PDA J Pharm Sci Technol. 2019 May-Jun;73(3):285-291. doi: 10.5731/pdajpst.2018.009340. Epub 2019 Jan 16. PDA J Pharm Sci Technol. 2019. PMID: 30651338

6

The Diffusion of Hydrogen Peroxide Into the Liquid Product During Filling Operations Inside Vaporous Hydrogen Peroxide-Sterilized Isolators Can Be Predicted by a Mechanistic Model.

Vuylsteke B, Luyckx I, de Lannoy G. Vuylsteke B, et al. J Pharm Sci. 2019 Aug;108(8):2527-2533. doi: 10.1016/j.xphs.2019.03.033. Epub 2019 Apr 6. J Pharm Sci. 2019. PMID: 30959053

7

Rapid assessment of oxidation via middle-down LCMS correlates with methionine side-chain solvent-accessible surface area for 121 clinical stage monoclonal antibodies.

Yang R, Jain T, Lynaugh H, Nobrega RP, Lu X, Boland T, Burnina I, Sun T, Caffry I, Brown M, Zhi X, Lilov A, Xu Y. Yang R, et al. MAbs. 2017 May/Jun;9(4):646-653. doi: 10.1080/19420862.2017.1290753. Epub 2017 Feb 14. MAbs. 2017. PMID: 28281887 Free PMC article.

8

Prediction of the Hydrogen Peroxide-Induced Methionine Oxidation Propensity in Monoclonal Antibodies.

Agrawal NJ, Dykstra A, Yang J, Yue H, Nguyen X, Kolvenbach C, Angell N. Agrawal NJ, et al. J Pharm Sci. 2018 May;107(5):1282-1289. doi: 10.1016/j.xphs.2018.01.002. Epub 2018 Jan 8. J Pharm Sci. 2018. PMID: 29325924

9

Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying-the Road to Manufacturing Scale.

Gikanga B, Turok R, Hui A, Bowen M, Stauch OB, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):59-73. doi: 10.5731/pdajpst.2015.01003. PDA J Pharm Sci Technol. 2015. PMID: 25691715

10

Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2.

Lam XM, Yang JY, Cleland JL. Lam XM, et al. J Pharm Sci. 1997 Nov;86(11):1250-5. doi: 10.1021/js970143s. J Pharm Sci. 1997. PMID: 9383735

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