日本PDA学術誌 GMPとバリデーション
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
総説
シングルユースシステムを用いて製造されるバイオ医薬品の品質確保に関する提言
石井 明子橋井 則貴松本 真理子香取 典子新井 進粟津 洋寿磯野 哲也井上 友美永座 明大山 幸仁奥村 剛宏梶原 大介田熊 晋也丹下 浩一塚原 正義筒井 麻衣子寺島 伊予中川 泰志郎服部 秀志林 慎介原 芳明松田 博行村上 聖矢野 高広巌倉 正寛大政 健史川崎 ナナ広瀬 明彦
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2017 年 19 巻 2 号 p. 15-29

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 The use of single-use systems has been getting more popular in biologics manufacturing. Utilization of this novel technology enables the efficient manufacturing, including prevention of cross contamination, flexibility to manufacture multiple products, and elimination of the need for cleaning and steam sterilization including those validations. In order to ensure the quality and stable supply of biologics, appropriate risk management considering the characteristics of the system is necessary. However, there is no regulatory document describing the examples or recommendations on it. In 2015, we published the White paper of “Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics” in AAPS PharmSciTech, which was a fruit of discussion in the research group consisting of Japanese pharmaceutical manufacturers, single-use suppliers, academia and regulatory agencies. This review introduces the contents of the White paper with some revision reflecting the comments on it as well as the discussion in our research group after publishing the paper. The basic concept is consistent with ICH guideline on quality risk management. Here we describe the points to consider in risk assessment as well as in risk control when single-use systems are used in biologics manufacturing.

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