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Biopharmaceutical Sciences Lab
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The lab evaluates the quality and safety of biopharmaceuticals.
AboutAbout the lab
Evaluating the quality and safety of biopharmaceuticals
The Division of Biological Chemistry and Biologicals at the National Institute of Health Sciences conducts regulatory science research that helps ensure the quality, efficacy, and safety of biopharmaceuticals.
The products studied include novel biopharmaceuticals with new active ingredients and biosimilars (follow-on biologics).
Its goal is to develop the evaluation methods needed to manage quality risks and to take the lead in advancing standardization.
The introduction of the Biopharmaceutical Sciences Lab is based on the content of this division's website.
Key terms
- Regulatory science
- A research field that adjusts the outcomes of science and technology so that they harmonize with people and society and serve the public interest
- Biosimilar
- A follow-on biopharmaceutical developed by demonstrating its similarity to an existing reference biopharmaceutical. Also called a follow-on biologic
- Immunogenicity
- The property of a drug to trigger an immune response in the body
- Antibody-drug conjugate
- A drug in which a drug substance is attached to an antibody
NewsLab news
A researcher from the Division of Biological Chemistry and Biologicals received the Academic Encouragement Award at the Japan Society of Molecular Tumor Marker Research
A researcher from the Division of Biological Chemistry and Biologicals received the Presidential Special Award at the 49th Annual Meeting of the Japanese Society of Myeloma
ResearchResearch themes
According to the division's research overview for fiscal year 2024, the lab conducts regulatory science research that helps ensure the quality, efficacy, and safety of biopharmaceuticals and biosimilars (follow-on biologics). Its work ranges from developing analytical methods and evaluating immunogenicity to establishing public test methods such as those in the Japanese Pharmacopoeia, with the aim of contributing to the administration of health and welfare policy by the Ministry of Health, Labour and Welfare.
*Illustrative imageQuality Evaluation of Biopharmaceuticals
The lab works on developing evaluation methods for examining the quality of biopharmaceuticals. Its work includes evaluating protein aggregates and insoluble particles, characterizing antibody structures using mass spectrometry, measuring impurities derived from the manufacturing process, and comparing biosimilars with their reference products.
*Illustrative imageEvaluation of Efficacy and Safety
The lab works on developing analytical methods for measuring antibody-drug conjugates in human plasma, evaluating immunogenicity (the property of a drug to trigger an immune response), and drafting evaluation guidelines. It also studies methods for measuring anti-drug antibodies.
*Illustrative imageEstablishing Pharmacopoeial and Other Public Test Methods
The lab works on establishing monographs and test methods for biological products listed in the Japanese Pharmacopoeia, and surveys the differences among the Japanese, US, and European pharmacopoeias. It also drafts proposals in expert working groups for the revision of ICH guidelines.
*Illustrative imageEvaluation of Cutting-Edge Biopharmaceuticals
In addition to research on analytical methods that use cryo-electron microscopy to examine the higher-order structure of next-generation antibody drugs, the lab works on quality evaluation of conjugated antibodies (antibodies with molecules attached), IgA products, and peptide drugs.
MembersFaculty
- Director石井 明子
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “HK Chai Wan IVE Pharmaceutical Science Laboratory Codonopsis pilosula Room 516” Chlaborewan / CC BY-SA 3.0 (cropped)
- Quality Evaluation of Biopharmaceuticals: “Biological Mass Spectrometry ( )” Oak Ridge National Laboratory / CC BY 2.0 (cropped)
- Evaluation of Efficacy and Safety: “Antibody-drug-conjugate 01” User:Kuebi = Armin Kübelbeck / CC BY-SA 3.0 (cropped)
- Establishing Pharmacopoeial and Other Public Test Methods: “Zh pharmacopoeia 2” 作者不詳 / Public domain (cropped)
- Evaluation of Cutting-Edge Biopharmaceuticals: “Antibody IgG1 structure” Tokenzero / CC BY-SA 4.0 (cropped)
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