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Lyophilization of Pharmaceuticals and Biologicals

New Technologies and Approaches

  • Book
  • © 2019

Overview

Editors:
  1. Kevin R. Ward

    1. Biopharma Process Systems Ltd., Winchester, UK

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. Paul Matejtschuk

    1. National Institute for Biological Standards & Control (NIBSC), Potters Bar, UK

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • Includes cutting-edge techniques
  • Provides step-by-step detail essential for reproducible results
  • Contains key implementation advice from the experts

Part of the book series: Methods in Pharmacology and Toxicology (MIPT)

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Table of contents (14 protocols)

  1. Front Matter

    Pages i-xiv
    Download chapter PDF

  2. Characterization of Formulations for Freeze-Drying

    • Kevin R. Ward, Paul Matejtschuk
    Pages 1-32

  3. Formulation and Process Development for Lyophilized Biological Reference Materials

    • Paul Matejtschuk, Kiran Malik, Chinwe Duru
    Pages 33-55

  4. Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method

    • Jacob Luoma, Graham Magill, Lokesh Kumar, Zakaria Yusoff
    Pages 57-77

  5. Alternative Methods of Controlling Nucleation in Freeze Drying

    • Roberto Pisano
    Pages 79-111

  6. Tunable Diode Laser Absorption Spectroscopy in Lyophilization

    • William J. Kessler, Emily Gong
    Pages 113-141

  7. Containment Options for the Freeze-Drying of Biological Entities and Potent Materials

    • Chris Cherry
    Pages 143-155

  8. Freeze-Drying Systems: Freeze Dryer Interface Design Requirements and Automatic Loading and Unloading Systems (ALUS™)

    • Maik Guttzeit, Carolin Wolf, Johannes Selch, Thomas Beutler
    Pages 157-172

  9. Regulatory Aspects of Freeze-Drying

    • David Awotwe-Otoo, Mansoor Khan
    Pages 173-192

  10. Container and Reconstitution Systems for Lyophilized Drug Products

    • T. Page McAndrew, Douglas Hostetler, Frances L. DeGrazio
    Pages 193-214

  11. Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT), and Statistical Analysis

    • Erwan Bourlès, Gael de Lannoy, Bernadette Scutellà, Fernanda Fonseca, Ioan Cristian Trelea, Stephanie Passot
    Pages 215-240

  12. Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development

    • Geoff Smith, Evgeny Polygalov
    Pages 241-290

  13. Lyophilization of High-Concentration Protein Formulations

    • Patrick Garidel, Ingo Presser
    Pages 291-325

  14. Mechanical Behavior and Structure of Freeze-Dried Cakes

    • Sarah H. M. Hedberg, Sharmila Devi, Arnold Duralliu, Daryl R. Williams
    Pages 327-351

  15. High-Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids

    • Karthik Balakrishna Chandrababu, Rajashekar Kammari, Yuan Chen, Elizabeth M. Topp
    Pages 353-375

  16. Back Matter

    Pages 377-382
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Keywords

About this book

This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. 

Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Editors and Affiliations

  • Biopharma Process Systems Ltd., Winchester, UK

    Kevin R. Ward

  • National Institute for Biological Standards & Control (NIBSC), Potters Bar, UK

    Paul Matejtschuk

Bibliographic Information

  • Book Title: Lyophilization of Pharmaceuticals and Biologicals

  • Book Subtitle: New Technologies and Approaches

  • Editors: Kevin R. Ward, Paul Matejtschuk

  • Series Title: Methods in Pharmacology and Toxicology

  • DOI: https://doi.org/10.1007/978-1-4939-8928-7

  • Publisher: Humana New York, NY

  • eBook Packages: Springer Protocols

  • Copyright Information: Springer Science+Business Media, LLC, part of Springer Nature 2019

  • Hardcover ISBN: 978-1-4939-8927-0Published: 19 December 2018

  • eBook ISBN: 978-1-4939-8928-7Published: 18 December 2018

  • Series ISSN: 1557-2153

  • Series E-ISSN: 1940-6053

  • Edition Number: 1

  • Number of Pages: XIV, 382

  • Number of Illustrations: 40 b/w illustrations, 148 illustrations in colour

  • Topics: Pharmacology/Toxicology

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