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Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals

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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This chapter provides a historical reference, covers the progression in the scientific and technological development, highlights the contemporary aspects, and describes the application of the current USFDA guidance to the development through commercial life cycle for lyophilized products. Considerations of designing formulations, including the use of organic solvents, and influence of packaging are noted. Emphasis is placed on the engineering of the lyophilization process, establishing the critical process parameters, and defining of the critical quality attributes. Utility of applying the US FDA process analytical technology initiative, as well as the notion of applying design space principles to the lyophilization process is included, leading into discussions on applying the current USFDA guideline on process validation to the development and manufacturing. Current challenges and unique aspects in development of lyophilized products are also highlighted, including poorly soluble drug substances, novel delivery systems, improving manufacturing capabilities, and reducing unit costs for world wide product distribution. This presentation encompasses the progression of the technological developments, reviews current thinking on the science and technology, and highlights contemporary approaches to the development and manufacturing of lyophilized parenterals.

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Notes

  1. 1.

    An independent variable is those that are under direct control and are not resulting from influencing factors or dependent upon other processing variables.

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Author information

Authors and Affiliations

  1. Lyophilization Technology, Inc., Ivyland, PA, USA

    Edward H. Trappler

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  1. Edward H. Trappler
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Correspondence to Edward H. Trappler .

Editor information

Editors and Affiliations

  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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© 2013 American Association of Pharmaceutical Scientists

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Trappler, E.H. (2013). Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals. 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_11

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