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

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

doi:10.1016/j.jpha.2023.12.006

Volume 14 Issue 6

Jun. 2024

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Article Navigation > Journal of Pharmaceutical Analysis > 2024 > 14(6): 100916

Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpaktr, Songsak Tongchusak, Maoxin Tim Tian, Trairak Pisitkun. Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics[J]. Journal of Pharmaceutical Analysis, 2024, 14(6): 100916. doi: 10.1016/j.jpha.2023.12.006

Citation:

Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpaktr, Songsak Tongchusak, Maoxin Tim Tian, Trairak Pisitkun. Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics[J]. Journal of Pharmaceutical Analysis, 2024, 14(6): 100916. doi: 10.1016/j.jpha.2023.12.006

Citation:

Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpaktr, Songsak Tongchusak, Maoxin Tim Tian, Trairak Pisitkun. Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics[J]. Journal of Pharmaceutical Analysis, 2024, 14(6): 100916. doi: 10.1016/j.jpha.2023.12.006

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

doi: 10.1016/j.jpha.2023.12.006

a. Department of Food and Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Pathumwan, Bangkok, 10330, Thailand;
b. Pharmaceutical Sciences and Technology (PST) Graduate Program, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Pathumwan, Bangkok, 10330, Thailand;
c. Center of Excellence in Systems Biology (CUSB), Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, 10330, Thailand;
d. Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Huachiew Chalermprakiet University, Bang Phli, Samut Prakan, 10540, Thailand;
e. Division of Research Affairs, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, 10330, Thailand

Funds:

This work was supported by the Grant for Development of New Faculty Staff, Ratchadaphiseksomphot Endowment Fund, Chulalongkorn 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 Education, Science, Research and Innovation, Thailand (Grant No.: RGNS64_012 to Patanachai K. Limpikirati).

Received Date: Jul. 24, 2023
Accepted Date: Dec. 07, 2023
Rev Recd Date: Nov. 04, 2023
Publish Date: Dec. 10, 2023

Abstract

Abstract

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 understanding 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.
- Biopharmaceutical analysis,
- Biopharmaceutical quality control,
- Biopharmaceutical specifications,
- Monoclonal antibodies,
- Protein therapeutics,
- Regulatory science

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References(248)

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