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Quality Attributes of a Biopharmaceutical

  • John Geigert
Chapter

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 biological properties or characteristics. In this chapter, seven major categories of quality attributes for all biopharmaceuticals that need to be tested are examined – appearance/description, identity, purity/impurities, potency, quantity, adventitious agent safety, and general. Specific testing to meet the requirements of each of these quality attributes for each biopharmaceutical type is discussed.

Keywords

Molecular properties Appearance/Description Identity Purities/Impurities Low Endotoxin Recovery (LER) Potency Quantity Adventitious agents Intrinsic particulates Proteinaceous particles 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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