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Quality by Design risk assessments supporting approved antibody products

Pages 1435-1436 | Received 31 Aug 2016, Accepted 31 Aug 2016, Published online: 13 Oct 2016

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Huawei Qiu, Ronnie Wei, Julie Jaworski, Ekaterina Boudanova, Heather Hughes, Scott VanPatten, Anders Lund, Jaime Day, Yanfeng Zhou, Tracey McSherry, Clark Q. Pan & Rebecca Sendak. (2019) Engineering an anti-CD52 antibody for enhanced deamidation stability. mAbs 11:7, pages 1266-1275.
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Kefan Zhang, Haiyan Wang, Liang Zhong, Lanling Liu, Ruiqi Huang, Hui Zhang, Dongbo Xu, Wenping Yin, Lian Li & Hengchang Zang. (2021) Evaluation and Monitoring of the API Content of a Portable Near Infrared Instrument Combined with Chemometrics Based on Fluidized Bed Mixing Process. Journal of Pharmaceutical Innovation 17:4, pages 1136-1147.
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Mayang Dewi, Reza Pratama, Mia Arifka & Anis Chaerunisaa. (2022) Quality By Design: Approach to Analytical Method Validation. Sciences of Pharmacy 1:1, pages 33-40.
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Damien van de Berg, Zoltán Kis, Carl Fredrik Behmer, Karnyart Samnuan, Anna K. Blakney, Cleo Kontoravdi, Robin Shattock & Nilay Shah. (2021) Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases. npj Vaccines 6:1.
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Y. Diana Liu, Yan Chen, George Tsui, Bingchuan Wei, Feng Yang, Christopher Yu & Christopher Cornell. (2020) Predictive In Vitro Vitreous and Serum Models and Methods to Assess Thiol-Related Quality Attributes in Protein Therapeutics . Analytical Chemistry 92:10, pages 6869-6876.
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Kohei Tahara. (2020) Pharmaceutical formulation and manufacturing using particle/powder technology for personalized medicines. Advanced Powder Technology 31:1, pages 387-392.
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Stanley Chung, Jun Tian, Zhijun Tan, Jie Chen, Jongchan Lee, Michael Borys & Zheng Jian Li. (2018) Industrial bioprocessing perspectives on managing therapeutic protein charge variant profiles. Biotechnology and Bioengineering 115:7, pages 1646-1665.
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Xin Wang, Zhiqiang An, Wenxin Luo, Ningshao Xia & Qinjian Zhao. (2017) Molecular and functional analysis of monoclonal antibodies in support of biologics development. Protein & Cell 9:1, pages 74-85.
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