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Formulation Approaches and Strategies for PEGylated Biotherapeutics

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Sterile Product Development

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 6))

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Abstract

This chapter will begin with a brief review of the PEGylated biotherapeutic product landscape (commercial products and known molecules in development) and then discuss various product development approaches and issues. Several topics pertinent to PEGylated biotherapeutics formulation development include manufacturability, linker and conjugate stability, and viscosity and PEG reagent design. A discussion on each topic will be presented with a focus on strategies to overcome typical hurdles encountered.

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Notes

  1. 1.

    After this manuscript had been submitted, Peginesatide had received FDA approval, making it the eleventh PEGylated biotherapeutic to gain approval.

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Acknowledgments

The authors wish to thank the reviewers (Bakul Bhatnagar, Monika Geiger, Jamie Harrington, Sheetal Pai, Julia Rashba-Step, and Yuyan Zhao) for their helpful suggestions; Monika Geiger for her translation skills; and Jason Fernandez, Jamie Harrington, and Aadi Krishnan for their valuable contributions.

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Authors and Affiliations

  1. BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, One Burtt Road, Andover, MA, 01810, USA

    Roger H. Pak & Rory F. Finn

  2. BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, 700 Chesterfield Parkway, West Chesterfield, MO, 63017, USA

    Rory F. Finn

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  1. Roger H. Pak
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  2. Rory F. Finn
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Correspondence to Roger H. Pak .

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  1. Pharmaceutical R&D-BioTx Pharmaceutical, Chesterfield, Missouri, USA

    Parag Kolhe

  2. LifeCell Corporation, Bridgewater, New Jersey, USA

    Mrinal Shah

  3. Drug Product Engineering, Amgen, Thousand Oaks, California, USA

    Nitin Rathore

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Pak, R.H., Finn, R.F. (2013). Formulation Approaches and Strategies for PEGylated Biotherapeutics. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_4

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