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Book Chapter

Quality Attributes of a Biopharmaceutical

  • Geigert J
Springer International Publishing, (2019), 311-329
DOI: 10.1007/978-3-030-13754-0_11
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Abstract

A biopharmaceutical (whether recombinant protein, monoclonal antibody, genetically engineered virus or genetically engineered cell) is defined by its quality attributes. These attributes can be physical, molecular, cellular, immunochemical, microbiological and/or...

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Geigert, J. (2019). Quality Attributes of a Biopharmaceutical. In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (pp. 311–329). Springer International Publishing. https://doi.org/10.1007/978-3-030-13754-0_11

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