Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics-Reference-Cited by-同舟云学术

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Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics

Published:2019 Issue:6 Volume:73 Page:622-634
ISSN:1079-7440
Container-title:PDA Journal of Pharmaceutical Science and Technology
language:en
Short-container-title:

Author:

Valliere-Douglass John,Marzilli Lisa,Deora Aparna,Du Zhimei,He Luhong,Kumar Sampath R.,Liu Yan-Hui,Mueller Hans-Martin,Nwosu Charles,Stults John,Wang Yan,Yaghmour Sam,Zhou Yizhou

Publisher

Parenteral Drug Association, Inc.

Subject

Pharmaceutical Science

Cited by 8 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. A Spike-Control Approach that Evaluates High Resolution Mass Spectrometry-Based Sequence Variant Analytical Method Performance for Therapeutic Proteins;Pharmaceutical Research;2023-05-01

2. Seemingly Endless Biomolecular Structural Variants;The Challenge of CMC Regulatory Compliance for Biopharmaceuticals;2023

3. Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study;Scientific Reports;2021-06-24

4. Benchmarking and optimization of a high‐throughput sequencing based method for transgene sequence variant analysis in biotherapeutic cell line development;Biotechnology Journal;2021-06-03

5. Scientific Best Practices for Primary Sequence Confirmation and Sequence Variant Analysis in the Development of Therapeutic Proteins;Journal of Pharmaceutical Sciences;2021-02

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