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Implementation of a Platform Approach for Early Biologies Development

机译:实施早期生物学发展平台方法

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Since the beginning of development of monoclonal antibodies (mAb) in the 1980s, they become vastly successful as efficacious and safe therapeutics for a variety of diseases. Today, they represent one of the fastest growing segments in the pharmaceutical industry.Nevertheless, the resources and risks associated with the development of new antibodies are immense and reflected in the low number of only ~ 33 antibodies that have been approved in the US whereas 4 were later withdrawn by the sponsor [1].
机译:自从1980年代开始开发单克隆抗体(mAb)以来,它们作为多种疾病的有效且安全的治疗剂已获得巨大成功。如今,它们代表了制药行业中发展最快的细分市场之一,然而,与开发新抗体相关的资源和风险巨大,这反映在美国仅约33种抗体中,数量很少,而4种后来被申办者撤回[1]。

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