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
Cell Line Development 遺伝子組み換えタンパク医薬の産生細胞の構築 （CHO細胞および大腸菌）
サービスカテゴリー：原薬、分析、研究･開発、製造
KBI's cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs to support cGMP manufacturing at KBI facilities.
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Mammalian Cell Line Development
Both transient expression and stable pool generation approaches are available to support proof-of-concept (POC) material generation for preclinical programs designed to meet the client’s timeline and budgetary objectives. |
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The master cell bank (MCB) generation is outsourced to established third-party vendors for full-scale process development and cGMP manufacturing programs. KBI conducts a vendor quality audit, transfers distribution vials of the selected RCB to the third party facility, manages and provides quality oversight of the pre-bank testing, the MCB production, testing, and release under cGMP. Learn more about our manufacturing services.
Microbial Cell Line Development
KBI applies proven, well-characterized, off-the-shelf, or engineered microbial recombinant protein expression systems to provide state-of-the-art cell line development. KBI leverages high throughput fermentation and analytical screening tools to rapidly identify the most promising expression strategy, including tailored approaches based on protein chemistry and structural assessment. Typical expression systems will drive soluble or insoluble protein accumulation in the cytosol, and periplasmic accumulation can be employed in specialized cases depending on the protein of interest. In instances where expression favors insoluble protein accumulation in inclusion bodies (IBs), KBI develops high-yielding recovery processes with the analytical characterization of conversion to an active product by solubilization and refolding procedures.
