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Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

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Biophysics for Therapeutic Protein Development

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

Abstract

The emerging technologies in protein engineering and the greater demand for next-generation protein therapeutics with enhanced efficacy, safety, reduced immunogenicity, and improved delivery are translating into increased nomination of more extensively engineered, difficult to develop candidates for development. Recent advances in protein structure, stability, and function relationship combined with advances in biophysics are enabling more comprehensive and accurate developability and manufacturability screening during early research stages. This chapter focuses on current and future challenges in developing therapeutic biological drugs and the application of novel biophysical tools to screen and improve potential developability properties. Based on stage-related requirements like predictability, speed, limited material, and resource availability, the suitability and application of various biophysical tools are discussed. Two case studies are provided to demonstrate the value of such an early risk assessment.

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Acknowledgements 

Authors wish to thank Nancy Craighead at MedImmune for critical review of this chapter.

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Authors and Affiliations

  1. Formulation Sciences, Biopharmaceutical Development, MedImmune, One Medimmune Way, Gaithersburg, MD, 20878, USA

    Hasige Sathish, Ambarish Shah & Steven Bishop

  2. Process and Product Development, Amgen Inc., One Amgen Center Drive, MS 30E-1-C, Thousand Oaks, CA, 91320, USA

    Nicolas Angell

  3. Antibody Discovery and Protein Engineering, Medimmune Ltd, The Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK

    David Lowe

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  1. Hasige Sathish
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  2. Nicolas Angell
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  3. David Lowe
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  4. Ambarish Shah
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  5. Steven Bishop
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Corresponding author

Correspondence to Hasige Sathish .

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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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Sathish, H., Angell, N., Lowe, D., Shah, A., Bishop, S. (2013). Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties. 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_6

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