Integrated Design of H2O2 Decontamination Processes and Scheduling in Sterile Drug Product Manufacturing-Reference-Cited by-同舟云学术

Integrated Design of H2O2 Decontamination Processes and Scheduling in Sterile Drug Product Manufacturing

Published:2020-02-18 Issue:2 Volume:16 Page:213-225
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Yabuta Keisho,Futamura Haruka,Kawasaki Koji,Sugiyama Hirokazu^ORCID

Funder

Airex Co., Ltd.

Japan Society for the Promotion of Science

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1007/s12247-020-09434-4.pdf

Reference23 articles.

1. Grilo AL, Mantalaris A. The increasingly human and profitable monoclonal antibody market. Trends Biotechnol. 2019;37:9–16. https://doi.org/10.1016/j.tibtech.2018.05.014.

2. International Agency for Research on Cancer. Agents classified by the IARC monographs. 2019. Volumes 1–125. https://monographs.iarc.fr/agents-classified-by-the-iarc/. Accessed 16 December 2019.

3. Wang W, Ignatius AA, Thakkar SV. Impact of residual impurities and contaminants on protein stability. J Pharm Sci. 2014;103:1315–30. https://doi.org/10.1002/jps.23931.

4. Eisner DE, Hubbard A, Eppler K, Tegoulia V, Maa Y-F. Vapor phase hydrogen peroxide uptake by silicone tubing and primary packaging components during protein drug product aseptic filling: impact by pre-treatment and sterilization process. PDA J Pharm Sci Technol. 2019;73:443–58. https://doi.org/10.5731/pdajpst.2019.009928.

5. Baur D, Angarita M, Müller-Späth T, Steinebach F, Morbidelli M. Comparison of batch and continuous multi-column protein A capture processes by optimal design. Biotechnol J. 2016;11:920–31. https://doi.org/10.1002/biot.201500481.

Cited by 2 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. Model-based investigation of a novel decontamination technology: Ultrasound assisted aerosolized hydrogen peroxide;Chemical Engineering Research and Design;2024-05

2. Data-driven anomaly detection and diagnostics for changeover processes in biopharmaceutical drug product manufacturing;Chemical Engineering Research and Design;2021-03