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Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

Patanachai K.Limpikirati Trairak Pisitkun Sorrayut Mongkoltipparat Thinnaphat Denchaipradit Nathathai Siwasophonpong Wudthipong Pornnopparat Parawan Ramanandana Phumrapee Pianpaktr Songsak Tongchusak Maoxin Tim Tian

药物分析学报（英文）2024，Vol.14Issue(6)：785-804,20.

药物分析学报（英文）2024，Vol.14Issue(6)：785-804,20.DOI:10.1016/j.jpha.2023.12.006

Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

Patanachai K.Limpikirati ¹Trairak Pisitkun ²Sorrayut Mongkoltipparat ³Thinnaphat Denchaipradit ³Nathathai Siwasophonpong ³Wudthipong Pornnopparat ³Parawan Ramanandana ⁴Phumrapee Pianpaktr ¹Songsak Tongchusak ⁵Maoxin Tim Tian⁵

作者信息

1. Department of Food and Pharmaceutical Chemistry,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Pharmaceutical Sciences and Technology(PST)Graduate Program,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Center of Excellence in Systems Biology(CUSB),Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand
2. Center of Excellence in Systems Biology(CUSB),Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Division of Research Affairs,Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand
3. Department of Food and Pharmaceutical Chemistry,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand
4. Department of Food and Pharmaceutical Chemistry,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Pharmaceutical Sciences and Technology(PST)Graduate Program,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Center of Excellence in Systems Biology(CUSB),Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand||Department of Pharmaceutical Chemistry,Faculty of Pharmaceutical Sciences,Huachiew Chalermprakiet University,Bang Phli,Samut Prakan,10540,Thailand
5. Center of Excellence in Systems Biology(CUSB),Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand
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摘要

关键词

Biopharmaceutical analysis/Biopharmaceutical quality control/Biopharmaceutical specifications/Monoclonal antibodies/Protein therapeutics/Regulatory science

Key words

Biopharmaceutical analysis/Biopharmaceutical quality control/Biopharmaceutical specifications/Monoclonal antibodies/Protein therapeutics/Regulatory science

引用本文复制引用

Patanachai K.Limpikirati,Trairak Pisitkun,Sorrayut Mongkoltipparat,Thinnaphat Denchaipradit,Nathathai Siwasophonpong,Wudthipong Pornnopparat,Parawan Ramanandana,Phumrapee Pianpaktr,Songsak Tongchusak,Maoxin Tim Tian..Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics[J].药物分析学报（英文）,2024,14(6):785-804,20.

基金项目

This work was supported by the Grant for Development of New Faculty Staff,Ratchadaphiseksomphot Endowment Fund,Chula-longkorn University,Thailand(Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati)and Grant for Development of New Scholar,Office of the Permanent Secretary,Ministry of Higher Ed-ucation,Science,Research and Innovation,Thailand(Grant No.:RGNS64_012 to Patanachai K.Limpikirati).Assoc.Prof.Bodin Tue-suwan,Ph.D.,R.Ph.,FCIP and Assoc.Prof.Vorasit Vongsutilers,Ph.D.,R.Ph.(Chulalongkorn University)are thanked for their efforts in educating Thai pharmacists with scientific knowledges and con-cerns on the quality of medicines.Patanachai K.Limpikirati is also grateful to Prof.Richard W.Vachet,Ph.D.(University of Massa-chusetts Amherst,USA)for introducing him to the world of bio-pharmaceutical analysis. （Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati）

药物分析学报（英文）

ISSN：2095-1779

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