Manufacuturing, Development and Regulatory Matters on Biologics, from the Standpoint of the Industory

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  • UCHIDA Kazuhisa
    日本製薬工業協会バイオ医薬品委員会 技術実務委員長
  • MATSUZAKI Junichi
    日本製薬工業協会バイオ医薬品委員会 政策実務副委員長
  • HYOGO Atsushi
    日本製薬工業協会バイオ医薬品委員会 政策実務委員長

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Other Title
  • バイオ医薬品の製造・開発と規制上の課題 (企業としての立場から)
  • バイオ イヤクヒン ノ セイゾウ ・ カイハツ ト キセイ ジョウ ノ カダイ(キギョウ ト シテ ノ タチバ カラ)

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<p>Biologics are important in the pharmaceutical market worldwide, and future growth including biosimilars is expected. On the other hand, it has characteristics different from low molecule drugs in manufacturing development, manufacturing facilities, etc., and there are many problems unique to biologics. Also, some of these issues reflect the trend of global drug development trends, and some are specific to Japan. In this article, from the standpoint of industry, we state opinions regarding manufacturing, development and regulatory matters on biologics to in Japan. Viewpoints include biomanufacturing infrastructure, adaptation to expedited programs on drug development and human resource development for biomanufacturing.</p>

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