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612 results on '"Omasa, Takeshi"'

155. Neuraminidase gene homology contributes to the protective activity of influenza vaccines prepared from the influenza virus library

Author

Haredy, Ahmad M., primary, Yamada, Hiroshi, additional, Sakoda, Yoshihiro, additional, Okamatsu, Masatoshi, additional, Yamamoto, Naoki, additional, Omasa, Takeshi, additional, Mori, Yasuko, additional, Kida, Hiroshi, additional, Okamoto, Shigefumi, additional, Okuno, Yoshinobu, additional, and Yamanishi, Koichi, additional

Published
2014
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156. Rearranging the domain order of a diabody-based IgG-like bispecific antibody enhances its antitumor activity and improves its degradation resistance and pharmacokinetics

Author

Asano, Ryutaro, primary, Shimomura, Ippei, additional, Konno, Shota, additional, Ito, Akiko, additional, Masakari, Yosuke, additional, Orimo, Ryota, additional, Taki, Shintaro, additional, Arai, Kyoko, additional, Ogata, Hiromi, additional, Okada, Mai, additional, Furumoto, Shozo, additional, Onitsuka, Masayoshi, additional, Omasa, Takeshi, additional, Hayashi, Hiroki, additional, Katayose, Yu, additional, Unno, Michiaki, additional, Kudo, Toshio, additional, Umetsu, Mitsuo, additional, and Kumagai, Izumi, additional

Published
2014
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162. An MDCK Cell Culture-Derived Formalin-Inactivated Influenza Virus Whole-Virion Vaccine from an Influenza Virus Library Confers Cross-Protective Immunity by Intranasal Administration in Mice

Author

Haredy, Ahmad M., primary, Takenaka, Nobuyuki, additional, Yamada, Hiroshi, additional, Sakoda, Yoshihiro, additional, Okamatsu, Masatoshi, additional, Yamamoto, Naoki, additional, Omasa, Takeshi, additional, Ohtake, Hisao, additional, Mori, Yasuko, additional, Kida, Hiroshi, additional, Yamanishi, Koichi, additional, and Okamoto, Shigefumi, additional

Published
2013
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170. Enhancement of sialylation on humanized IgG-like bispecific antibody by overexpression of α2,6-sialyltransferase derived from Chinese hamster ovary cells

Author

Onitsuka, Masayoshi, primary, Kim, Wook-Dong, additional, Ozaki, Hiroyuki, additional, Kawaguchi, Akira, additional, Honda, Kohsuke, additional, Kajiura, Hiroyuki, additional, Fujiyama, Kazuhito, additional, Asano, Ryutaro, additional, Kumagai, Izumi, additional, Ohtake, Hisao, additional, and Omasa, Takeshi, additional

Published
2011
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190. Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

Author

Ishii-Watabe, Akiko, Hirose, Akihiko, Katori, Noriko, Hashii, Norikata, Arai, Susumu, Awatsu, Hirotoshi, Eiza, Akira, Hara, Yoshiaki, Hattori, Hideshi, Inoue, Tomomi, Isono, Tetsuya, Iwakura, Masahiro, Kajihara, Daisuke, Kasahara, Nobuo, Matsuda, Hiroyuki, Murakami, Sei, Nakagawa, Taishiro, Okumura, Takehiro, Omasa, Takeshi, and Takuma, Shinya

Abstract

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply. [ABSTRACT FROM AUTHOR]

Published
2015
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191. Optimization of cell line development in the GS-CHO expression system using a high-throughput, single cell-based clone selection system.

Author

Nakamura, Tsuyoshi and Omasa, Takeshi

Subjects
*CELL lines, *IMMUNOGLOBULINS, *CHO cell, *GLUTAMINE synthetase, *CLONING
Abstract

Therapeutic antibodies are commonly produced by high-expressing, clonal and recombinant Chinese hamster ovary (CHO) cell lines. Currently, CHO cells dominate as a commercial production host because of their ease of use, established regulatory track record, and safety profile. CHO-K1SV is a suspension, protein-free-adapted CHO-K1-derived cell line employing the glutamine synthetase (GS) gene expression system (GS-CHO expression system). The selection of high-producing mammalian cell lines is a crucial step in process development for the production of therapeutic antibodies. In general, cloning by the limiting dilution method is used to isolate high-producing monoclonal CHO cells. However, the limiting dilution method is time consuming and has a low probability of monoclonality. To minimize the duration and increase the probability of obtaining high-producing clones with high monoclonality, an automated single cell-based clone selector, the ClonePix FL system, is available. In this study, we applied the high-throughput ClonePix FL system for cell line development using CHO-K1SV cells and investigated efficient conditions for single cell-based clone selection. CHO-K1SV cell growth at the pre-picking stage was improved by optimizing the formulation of semi-solid medium. The efficiency of picking and cell growth at the post-picking stage was improved by optimization of the plating time without decreasing the diversity of clones. The conditions for selection, including the medium formulation, were the most important factors for the single cell-based clone selection system to construct a high-producing CHO cell line. [ABSTRACT FROM AUTHOR]

Published
2015
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