Abstract
The source material containing the genetic elements, coupled with the targeted design of a production/expression, harvest/isolation, and purification process, impacts the CMC regulatory compliance for the manufacture of the different biopharmaceutical APIs (also known as drug substance). The risk-based requirements and expectations for an adequate and appropriate control of the API manufacturing process, both upstream and downstream, across the lifecycle of the biopharmaceutical, are discussed. The advantages, and limitations, of the small-scale studies that are frequently used to characterize the API manufacturing process is presented.
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Geigert, J. (2019). Manufacturing of Biopharmaceutical APIs. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_6
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DOI: https://doi.org/10.1007/978-3-030-13754-0_6
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