Points to consider in quality assurance of biotechnology product manufacturing by using single-use systems
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- ISHII-WATABE Akiko
- National Institute of Health Sciences
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- HASHII Noritaka
- National Institute of Health Sciences
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- MATSUMOTO Mariko
- National Institute of Health Sciences
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- KATORI Noriko
- National Institute of Health Sciences
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- ARAI Susumu
- Sumitomo Bakelite Co., Ltd./Manufacturing Technology Association of Biologics (MAB)
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- AWATSU Hirotoshi
- Nihon Pall Ltd.
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- ISONO Tetsuya
- Chugai Pharma Manufacturing Co., Ltd
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- INOUE Tomomi
- MSD K.K.
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- EIZA Akira
- Sekisui Seikei Co., Ltd./Forum for Innovative Regenerative Medicine (FIRM)
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- OOYAMA Yukihito
- Kyowa Hakko Kirin Co., Ltd.
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- OKUMURA Takehiro
- Takeda Pharmaceutical Company Limited.
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- KAJIHARA Daisuke
- GE Healthcare Japan Corporation
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- TAKUMA Shinya
- Chugai Pharma Manufacturing Co., Ltd
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- TANGE Kouichi
- Daiichi Sankyo Chemical Pharma Co., Ltd.
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- TSUKAHARA Masayoshi
- Kyowa Hakko Kirin Co., Ltd.
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- TSUTSUI Maiko
- Sumitomo Dainippon Pharma Co., Ltd.
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- TERASHIMA Iyo
- Merck Ltd.
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- NAKAGAWA Taishiro
- Kyowa Hakko Kirin Co., Ltd.
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- HATTORI Hideshi
- Dai Nippon Printing Co., Ltd.
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- HAYASHI Shinsuke
- Astellas Parma Inc.
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- HARA Yoshiaki
- Sartorius Stedim Japan K.K.
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- MATSUDA Hiroyuki
- Fujimori Kogyo Co., Ltd./MAB
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- MURAKAMI Sei
- Hitachi Ltd.
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- YANO Takahiro
- Daiichi Sankyo Co., Ltd.
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- IWAKURA Masahiro
- MAB
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- OMASA Takeshi
- Osaka University/MAB
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- KAWASAKI Nana
- Yokohama City University
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- HIROSE Akihiko
- National Institute of Health Sciences
Bibliographic Information
- Other Title
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- 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
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Abstract
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.<br>
Journal
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- PDA Journal of GMP and Validation in Japan
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PDA Journal of GMP and Validation in Japan 19 (2), 15-29, 2017
Parenteral Drug Association Japan Chapter
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Details 詳細情報について
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- CRID
- 1390282679449656320
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- NII Article ID
- 130006262542
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- ISSN
- 18811728
- 13444891
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed