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Erschienen in:

2018 | OriginalPaper | Buchkapitel

High-Throughput Process Development for Biopharmaceuticals

verfasst von : Abhinav A. Shukla, Shahid Rameez, Leslie S. Wolfe, Nathan Oien

Erschienen in: New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Verlag: Springer International Publishing

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Abstract

The ability to conduct multiple experiments in parallel significantly reduces the time that it takes to develop a manufacturing process for a biopharmaceutical. This is particularly significant before clinical entry, because process development and manufacturing are on the “critical path” for a drug candidate to enter clinical development. High-throughput process development (HTPD) methodologies can be similarly impactful during late-stage development, both for developing the final commercial process as well as for process characterization and scale-down validation activities that form a key component of the licensure filing package. This review examines the current state of the art for HTPD methodologies as they apply to cell culture, downstream purification, and analytical techniques. In addition, we provide a vision of how HTPD activities across all of these spaces can integrate to create a rapid process development engine that can accelerate biopharmaceutical drug development.

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Titel: High-Throughput Process Development for Biopharmaceuticals
verfasst von: Abhinav A. Shukla
Shahid Rameez
Leslie S. Wolfe
Nathan Oien
Verlag: Springer International Publishing
Buch: New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins
Print ISBN: 978-3-319-97108-7

Electronic ISBN: 978-3-319-97110-0

Copyright-Jahr: 2018
DOI: https://doi.org/10.1007/10_2017_20

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