Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeuticsOA
Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics
In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen under-standing in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.
Patanachai K.Limpikirati;Trairak Pisitkun;Sorrayut Mongkoltipparat;Thinnaphat Denchaipradit;Nathathai Siwasophonpong;Wudthipong Pornnopparat;Parawan Ramanandana;Phumrapee Pianpaktr;Songsak Tongchusak;Maoxin Tim Tian
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,ThailandCenter 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,ThailandDepartment of Food and Pharmaceutical Chemistry,Faculty of Pharmaceutical Sciences,Chulalongkorn University,Pathumwan,Bangkok,10330,ThailandDepartment 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,ThailandCenter of Excellence in Systems Biology(CUSB),Faculty of Medicine,Chulalongkorn University,Pathumwan,Bangkok,10330,Thailand
Biopharmaceutical analysisBiopharmaceutical quality controlBiopharmaceutical specificationsMonoclonal antibodiesProtein therapeuticsRegulatory science
《药物分析学报（英文）》 2024 (006)
785-804 / 20
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.
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