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Disposables for Biomanufacturing: A User's Perspective

机译:生物制造一次性用品:用户的观点

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The supply scenario for many biopharmaceutical drugs such as monoclonal antibodies (MAbs) is changing. With the implementation of personalized medicine resulting in drugs for specific, high-responder subsets of patients, market volume per drug will decrease. In addition, increasing fermentation titers of up to 10 g/L for MAbs are leading to smaller fermentation volumes necessary to accommodate individual biopharmaceutical market demands. That results in approaches such as flexible production in campaigns or decentralization of manufacturing using similar facilities with low risk of tech-transfer issues for regional markets.
机译:许多生物制药药物(如单克隆抗体(MAb))的供应情况正在发生变化。随着个性化医疗的实施,导致针对特定的,高反应性患者亚群的药物的使用,每种药物的市场容量将减少。此外,针对MAb的发酵滴定度提高至高达10 g / L,导致需要较小的发酵量以适应各个生物制药市场的需求。这导致了诸如在活动中进行灵活生产或使用类似设施的生产分散化等方法,从而降低了区域市场的技术转让问题的风险。

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