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Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

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Biophysics for Therapeutic Protein Development

Part of the book series: Biophysics for the Life Sciences ((BIOPHYS,volume 4))

Abstract

During the manufacture, storage, and administration of protein therapeutics, aggregates and particles of varying size can form. The presence of these impurities may directly affect the immunogenicity and efficacy of the protein-based drugs. The detection and characterization of protein aggregates and particles has therefore become increasingly important from a pharmaceutical perspective, especially the use of different analytical technologies to comprehensively characterize the number, size range, morphology, and composition of protein aggregates and particles over a wide size range. This review chapter evaluates recent case studies that have utilized a combination of biophysical techniques to characterize soluble protein aggregates (1–100 nm) as well as submicron-sized (100–1,000 nm), subvisible (1–100 μm), and visible (>100 μm) protein particles. The case studies not only provide interesting comparisons of different biophysical methods but also examine varying effects observed with different protein therapeutics formulated in different dosage forms.

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Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, Macromolecule and Vaccine Stabilization Center, University of Kansas, 2030 Becker Drive, Lawrence, KS, 66047, USA

    Tingting Wang, Sangeeta B. Joshi, Ozan S. Kumru, Srivalli Telikepalli, C. Russell Middaugh & David B. Volkin

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  1. Tingting Wang
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  2. Sangeeta B. Joshi
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  3. Ozan S. Kumru
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  4. Srivalli Telikepalli
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  5. C. Russell Middaugh
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  6. David B. Volkin
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Correspondence to David B. Volkin .

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  1. , Research & Development, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, 91320, California, USA

    Linda O. Narhi

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Wang, T., Joshi, S.B., Kumru, O.S., Telikepalli, S., Middaugh, C.R., Volkin, D.B. (2013). Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size. In: Narhi, L. (eds) Biophysics for Therapeutic Protein Development. Biophysics for the Life Sciences, vol 4. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4316-2_9

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