Sterile Product Development

ebook ∣ Formulation, Process, Quality and Regulatory Considerations · AAPS Advances in the Pharmaceutical Sciences Series

By Parag Kolhe

cover image of Sterile Product Development

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Format

ebook

ISBN

9781461479772

Series

AAPS Advances in the Pharmaceutical Sciences Series

Author

Parag Kolhe

Publisher

Springer New York

Release

12 October 2013

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Subjects

Medical Science Nonfiction

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This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

  •  Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

  •  Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

  •  Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

    This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

    • Format

    ebook

    ISBN

    9781461479772

    Series

    AAPS Advances in the Pharmaceutical Sciences Series

    Author

    Parag Kolhe

    Publisher

    Springer New York

    Release

    12 October 2013

    Share

    Subjects

    Medical Science Nonfiction
    Sterile Product Development