Abstract
The two major forces that shape the corporate CMC regulatory compliance strategy for biopharmaceuticals are examined – tolerance of risk and resource allocation. Also, in this chapter, the five key design elements that comprise an effective corporate CMC regulatory compliance strategy for biopharmaceuticals are discussed in detail: (1) align CMC activities with corporate objective, (2) address CMC needs for the specific biopharmaceutical manufacturing process, (3) address CMC needs for the specific biopharmaceutical product, (4) align CMC activities with the strategic ICH guidances, and (5) apply a risk-based CMC regulatory compliance approach during clinical development.
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Geigert, J. (2019). An Effective CMC Strategy is Possible. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_3
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DOI: https://doi.org/10.1007/978-3-030-13754-0_3
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