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Challenges in Protein Product Development pp 407–439Cite as

Lyophilization: Process Design, Robustness, and Risk Management

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 38))

Abstract

This chapter briefly reviews the formulation literature with a focus on defining formulations that can support aggressive lyophilization. Each step in the lyophilization process is reviewed with considerations for scale-up with an emphasis on mathematical modeling (enabled by equipment characterization) and application of process analytical technologies, when possible. A scientific approach to process robustness relying upon grouping of process parameters to provide worst case conditions is described, and the consequences of grouping these parameters is discussed. Process robustness, assessed in this fashion, can then support the definition of the process design space and inform risk management activities.

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  1. BioTherapuetics Pharmaceutical Sciences, Pharmaceutical R&D, Pfizer, Inc, 1 Burtt Rd, Andover, MA, 01810, USA

    Daniel Dixon, Serguei Tchessalov & Bakul Bhatnagar

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  1. Daniel Dixon
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  2. Serguei Tchessalov
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  1. BioTherapeutics Research and Development Pharmaceutics Research and Development, Pfizer Inc., Andover, Massachusetts, USA

    Nicholas W. Warne

  2. Lonza AG, Drug Product Services, Basel, Basel Stadt, Switzerland

    Hanns-Christian Mahler

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Dixon, D., Tchessalov, S., Bhatnagar, B. (2018). Lyophilization: Process Design, Robustness, and Risk Management. In: Warne, N., Mahler, HC. (eds) Challenges in Protein Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 38. Springer, Cham. https://doi.org/10.1007/978-3-319-90603-4_19

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