YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
誌上シンポジウム
抗体医薬などのバイオ医薬品の物理化学的評価
内山 進
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ジャーナル フリー

2016 年 136 巻 3 号 p. 443-448

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  Biopharmaceuticals, including antibody drugs, are now popular because of their high specificity with low adverse effects, especially in the treatment of cancer and autoimmune diseases. However, because the active pharmaceutical ingredients of biopharmaceuticals are proteins, biophysical characterization of these therapeutic proteins should be required. In this manuscript, methods of chemical and physical characterization of therapeutic proteins are described. In terms of chemical characterization, analysis of chemical modifications of the constituent amino acids is explained. Physical characterization includes higher order structural analysis and assessment of protein aggregates. Quantification methods of aggregates with different sizes, recently encouraged by the U.S. Food and Drug Administration (FDA), are introduced. As for the stability of therapeutic proteins, the importance of chemical and physical stability is explained. Finally, the contribution of colloidal and structural stability to the production of an antibody drug less prone to aggregation is introduced.

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© 2016 The Pharmaceutical Society of Japan
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