JSR株式会社
JSRグループのライフサイエンス事業は「JSR Life Sciences」として、抗体医薬製造用材料（バイオプロセス用材料）、診断・研究試薬材料、抗体医薬開発・製造受託サービスを提供しています。
会社カテゴリー：原薬・添加剤・中間体、製造受託機関(CMO)、分析、試験受託サービス、医薬品製造関連資材、研究関連資材
主サービス提供地域：日本、アメリカ合衆国、中華人民共和国、大韓民国、台湾、ヨーロッパ(イギリス以外)、イギリス、インド
製品・サービス詳細
Process, Analytical, & Formulation Development 製造プロセス・分析試験法・製剤処方の開発
サービスカテゴリー：原薬、分析、製造、開発
KBI’s biopharmaceutical process development activities cover the full development cycle. From supporting early-stage discovery efforts and small-scale protein production, to fully-integrated, comprehensive process development programs leading to cGMP manufacturing.
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Biopharmaceutical process development and manufacturing KBI's process development activities cover the full development cycle. We support early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. We take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development. Our abiding customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients' biopharmaceutical process development needs. |
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Our process development services include:
KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture-derived proteins. The KBI team has worked with protein production processes at all scales, from laboratory, pilot, and clinical scales to commercial scales up to 2,000L. We have conducted cutting-edge research into several technologies fundamental to process development and are adept at solving challenging issues on very short timelines.
KBI has well-developed platform processes for monoclonal antibodies and Fc fusion proteins and has helped several clients create their own platforms for novel therapeutic moieties.
Our high throughput tools for process and analytical development include miniaturized bioreactors through the Ambr® platform, combined with high throughput chromatographic screening capabilities and a complimentary set of analytical tools to enable rapid progress in process development. Through our experience, we can readily develop optimal experimental strategies that can lead to the rapid development of robust, reliable, and scalable processes.
KBI’s full range of biopharma process development capabilities provides the tools to address client needs, whether in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.