Abstract
Product characterization is necessary to establish identity and consistency, and probably most important, patient safety, for any pharmaceutical, including a biopharmaceutical. But compared to chemical drugs, the biopharmaceuticals are large molecules (protein), or very large living particles (virus), or very very large living systems (cells). For a biopharmaceutical, product characterization includes the physical structures, the chemical properties, and in addition, the functional activities. Since there is so much that we can learn about these large molecules and there are so many test methods that we can use to study them, a risk-based approach is presented to determine what product characterization is necessary and when is that knowledge needed as the biopharmaceutical advances through clinical development from initial first-in-human studies to reaching market approval. In this chapter, the product characterization of three groups of biopharmaceuticals will be examined: (1) recombinant proteins and monoclonal antibodies, (2) genetically engineered viruses, and (3) genetically engineered cells.
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Geigert, J. (2019). Product Characterization is a Journey. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_9
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DOI: https://doi.org/10.1007/978-3-030-13754-0_9
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