Lyophilization of Pharmaceuticals and Biologicals

1. Front Matter

   Pages i-xiv

   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

    PDF

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.

• Freeze drying
• Product stabilization
• Generic drugs
• Antibody-drug conjugates
• Controlled nucleation technology
• Drug formulation
• Process monitoring

• Biopharma Process Systems Ltd., Winchester, UK

  Kevin R. Ward

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

  Paul Matejtschuk

Policies and ethics