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  • eBook:The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    John Geigert
    978-3-030-13754-0
    2019
    Edition 3
    • Updated with over 400 new or revised CMC regulatory compliance references since the 2ndedition
    • Thorough coverage of CMC regulatory compliance for recombinant proteins, monoclonal antibodies, biosimilars, genetically engineered viruses and genetically engineered cells
    • Addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process
    • Lessons learned from published FDA and EMA CMC regulatory compliance reviews of biopharmaceuticals that have sought market approval

    €300

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