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Parenteral Container Closure Systems

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Challenges in Protein Product Development

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

Abstract

Parenteral container closure systems are in direct contact with the drug product formulation and can significantly impact the product quality. The interaction between the drug product formulation and the primary packaging components may also impact adequate delivery of the product to the patient. Therefore, primary packaging development should be fully integrated into parenteral drug product development. This book chapter describes the basic function and requirements of a parenteral container closure system, advantages, and challenges with commonly used container closure system materials and components and the key benefits of combination products compared to traditional vial systems.

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Author information

Authors and Affiliations

  1. Hochbergerstrasse 60 a, 4057, Basel, Switzerland

    Roman Mathaes & Alexander Streubel

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  1. Roman Mathaes
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  2. Alexander Streubel
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Correspondence to Roman Mathaes .

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Editors and Affiliations

  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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Mathaes, R., Streubel, A. (2018). Parenteral Container Closure Systems. 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_8

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