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- W4290805859 abstract "This chapter outlines a review of the critical role bioanalysis has played in advancing the development of biotherapeutics. Starting with the introduction of the first biotherapeutics such as insulin, which involved extraction and purification of porcine or beef insulin for use in treating diabetes, bioanalysis has played a critical role in drug development. Some of the earliest and most critical aspects of the use of insulin as a biotherapeutic, such as formulation, were able to be addressed with accurate and precise bioanalytical measurements to drive understanding of pharmacokinetic (PK) properties. As immunogenicity evolved as a concern for biotherapeutics capable of initiating a humoral immune response, the large molecule bioanalytical scientist evolved to include immunogenicity assessment as part of their role. In addition to PK measurements, bioanalytical testing for gene therapy medicinal products will involve immunogenicity evaluation." @default.
- W4290805859 created "2022-08-12" @default.
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- W4290805859 date "2022-07-01" @default.
- W4290805859 modified "2023-10-16" @default.
- W4290805859 title "Overview of the Development of Biotherapeutics and the Role of Bioanalytical Sciences" @default.
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- W4290805859 doi "https://doi.org/10.1002/9781119523246.ch1" @default.
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