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Field-Flow Fractionation in Therapeutic Protein Development

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Field-Flow Fractionation in Biopolymer Analysis

Abstract

The development lifecycle for pharmaceutical proteins begins with target identification and demonstration of the biological relevance of a particular protein or protein property, continues to identification of which lead product candidate and cell line to advance, then proceeds through process and formulation development and characterization, clinical trials and commercialization. The launch of a product represents the beginning of a different kind of product support, which includes lot release, exploration of different delivery devices, comparability, and support for investigations. The past several decades have seen demonstration and documentation of the utility of asymmetrical flow field-flow fractionation (AF4) in biotechnology applicable to each of these protein drug development phases, but as yet, with limited industrial or routine implementation. This chapter seeks to provide a survey of such applications and potential opportunities for inspiration and exploitation of the distinct characteristics of AF4 throughout the long, winding and multifaceted drug development process.

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Author information

Authors and Affiliations

  1. Process and Product Development, Amgen Inc, Thousand Oaks, CA, USA

    Joey Pollastrini, Linda O. Narhi & Yijia Jiang

  2. M/S 30E-1-C, Amgen Inc. One Amgen Center Dr, Thousand Oaks, CA, USA

    Shawn Cao

Authors
  1. Joey Pollastrini
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  2. Linda O. Narhi
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  3. Yijia Jiang
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  4. Shawn Cao
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Corresponding author

Correspondence to Shawn Cao .

Editor information

Editors and Affiliations

  1. Colorado School of Mines, Golden Colorado, 80401, Colorado, USA

    S. Kim R. Williams

  2. Department of Physical and Analytical Chemistry, Section of, Uppsala, 751 23, Sweden

    Karin D. Caldwell

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Pollastrini, J., Narhi, L.O., Jiang, Y., Cao, S. (2012). Field-Flow Fractionation in Therapeutic Protein Development. In: Williams, S., Caldwell, K. (eds) Field-Flow Fractionation in Biopolymer Analysis. Springer, Vienna. https://doi.org/10.1007/978-3-7091-0154-4_5

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