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
Characterization & Consulting バイオ医薬品の分析サービス
サービスカテゴリー：原薬、開発、分析、製造
KBI offers a comprehensive range of analytical, biophysical characterization, mass spectrometry, and modeling and simulation capabilities. We apply these technologies to interpret your data and deliver information needed to support your product.
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Characterization & Consulting KBI has substantial experience in the design and execution of analytical comparability studies. We have executed such studies in support of reference material characterization, manufacturing site changes, and biosimilar-to-innovator comparability, to name a few. KBI can develop the protocol, perform the analyses, analyze the data, and provide a submission-ready comparability report with all requisite figures and tables. |
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Our Characterization and Consulting Services Include:
- Particle Characterization Core Facility
- Modeling & Simulation
- Biophysical Characterization
- CMC Submissions
- Mass Spectrometry Core Facility
Whether you seek developability data to support proof-of-concept, initial characterization for IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, KBI offers the experience and instrumentation needed to enhance the understanding of your molecule and accelerate development.