Lyophilization of Pharmaceuticals and Biologicals by Paul Matejtschuk
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Lyophilization of Pharmaceuticals and Biologicals

Lyophilization of Pharmaceuticals and Biologicals


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International Edition


About the Book

1. Characterization of Formulations for Freeze Drying

Kevin R. Ward and Paul Matejtschuk

2. Formulation and Process Development for Lyophilized Biological Reference Materials

Paul Matejtschuk, Kiran Malik, and Chinwe Duru

3. Controlled Ice Nucleation Using ControLyo(R) Pressurization-Depressurization Method

Jacob Luoma, Graham Magill, Lokesh Kumar, and Zakaria Yusoff

4. Alternative Methods of Controlling Nucleation in Freeze Drying

Roberto Pisano

5. Tunable Diode Laser Absorption Spectroscopy in Lyophilization

William J. Kessler and Emily Gong

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

Chris Cherry

7. Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS(TM))

Maik Gutzeitt, Carolin Wolf, Johannes Selch, and Thomas Beutler

8. Regulatory Aspects of Freeze Drying

David Awotwe-Otoo and Mansoor Khan

9. Container and Reconstitution Systems for Lyophilized Drug Products

T. Page McAndrew, Douglas Hostetler, and Frances L. DeGrazio

10. 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, I. Crostoam Trelea, and Stephanie Passot

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

Geoff Smith and Evgeny Polygalov

12. Lyophilization of High-Concentration Protein Formulations

Patrick Garidel and Ingo Presser

13. Mechanical Behavior and Structure of Freeze Dried Cakes

Sarah H.M. Hedberg, Sharmila Devi, Arnold Duralliu, and Daryl R. Williams

14. High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids

Karthik Balakrishna Chandrababu, Rajashekar Kammari, Yuan Chen, and Elizabeth M. Topp


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Product Details
  • ISBN-13: 9781493989270
  • Publisher: Humana Press
  • Publisher Imprint: Humana Press
  • Height: 254 mm
  • No of Pages: 382
  • Series Title: Methods in Pharmacology and Toxicology
  • Sub Title: New Technologies and Approaches
  • Width: 178 mm
  • ISBN-10: 1493989278
  • Publisher Date: 19 Dec 2018
  • Binding: Hardback
  • Language: English
  • Returnable: Y
  • Spine Width: 22 mm
  • Weight: 951 gr


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