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Freeze-Drying/Lyophilization of Pharmaceutical and

Biological Products

Start of Citation[PU]Marcel Dekker, Inc.[/PU][DP]1999[/DP]End of Citation

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DRUGS AND THE PHARMACEUTICAL SCIENCES

Executive Editor

James Swarbrick
AAl, Inc.
Wilmington, North Carolina

Advisory Board
Larry L. Augsburger
University of Maryland
Baltimore, Maryland
Douwe D. Breimer
Gorlaeus Laboratories
Leiden, The Netherlands
Trevor M. Jones
The Association of the
British Pharmaceutical Industry
London, United Kingdom
Hans E. Junginger
Leiden/Amsterdam Center
for Drug Research
Leiden, The Netherlands
Vincent H. L. Lee
University of Southern California
Los Angeles, California
David E. Nichols
Purdue University
West Lafayette, Indiana
Stephen G. Schulman
University of Florida
Gainesville, Florida
Jerome P. Skelly
Copley Pharmaceutical, Inc.
Canton, Massachusetts
Felix Theeuwes
Alza Corporation
Palo Alto, California
Geoffrey T. Tucker
University of Sheffield
Royal Hallamshire Hospital
Sheffield, United Kingdom

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Peter G. Welling
Institut de Recherche Jouveinal
Fresnes, France

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DRUGS AND THE PHARMACEUTICAL SCIENCES

A Series of Textbooks and Monographs
1. Pharmacokinetics, Milo Gibaldi and Donald Perrier
2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Sidney
H. Willig, Murray M. Tuckerman, and William S. Hitchings IV
3. Microencapsulation, edited by J. R. Nixon
4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testa and Peter Jenner
5. New Drugs: Discovery and Development, edited by Alan A. Rubin
6. Sustained and Controlled Release Drug Delivery Systems, edited by Joseph R. Robinson
7. Modern Pharmaceutics, edited by Gilbert S. Banker and Christopher T. Rhodes
8. Prescription Drugs in Short Supply: Case Histories, Michael A. Schwartz
9. Activated Charcoal: Antidotal and Other Medical Uses, David O. Cooney
10. Concepts in Drug Metabolism (in two parts), edited by Peter Jenner and Bernard Testa
11. Pharmaceutical Analysis: Modern Methods (in two parts), edited by James W. Munson
12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky
13. Orphan Drugs, edited by Fred E. Karch
14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, Biomedical
Assessments, Yie W. Chien
15. Pharmacokinetics: Second Edition, Revised and Expanded, Milo Gibaldi and Donald Perrier
16. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Second
Edition, Revised and Expanded, Sidney H. Willig, Murray M. Tuckerman, and William S.
Hitchings IV
17. Formulation of Veterinary Dosage Forms, edited by Jack Blodinger
18. Dermatological Formulations: Percutaneous Absorption, Brian W. Barry
19. The Clinical Research Process in the Pharmaceutical Industry, edited by Gary M. Matoren
20. Microencapsulation and Related Drug Processes, Patrick B. Deasy
21. Drugs and Nutrients: The Interactive Effects, edited by Daphne A. Roe and T. Colin
Campbell

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22. Biotechnology of Industrial Antibiotics, Erick J. Vandamme

23. Pharmaceutical Process Validation, edited by Bernard T. Loftus and Robert A. Nash
24. Anticancer and Antiferon Agents: Synthesis and Properties, edited by Raphael M. Ottenbrite
and George B. Butler
25. Pharmaceutical Statistics: Practical and Clinical Applications, Sanford Bolton
26. Drug Dynamics for Analytical, Clinical, and Biological Chemists, Benjamin J. Gudzinowicz,
Burrows T. Younkin, Jr., and Michael J. Gudzinowicz
27. Modern Analysis of Antibiotics, edited by Adjoran Aszalos
28. Soulbility and Related Properties, Kenneth C. James
29. Controlled Drug Delivery: Fundamentals and Applications, Second Edition, Revised and
Expanded, edited by Joseph R. Robinson and Vincent H. Lee
30. New Drug Approval Process: Clinical and Regulatory Management, edited by Richard A.
Guarino
31. Transdermal Controlled Systemic Medications, edited by Yie W. Chien
32. Drug Delivery Devices: Fundamentals and Applications, edited by Praveen Tyle

33. Pharmacokinetics: Regulatory • Industrial • Academic Perspectives, edited by Peter G.

Welling and Francis L.S. Tse
34. Clinical Drug Trials and Tribulations, edited by Allen E. Cato
35. Transdermal Drug Delivery: Developmental Issues and Research Initiatives, edited by
Joonathan Hadgraft and Richard H. Guy
36. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, edited by James W.
McGinity
37. Pharmaceutical Pelletization Technology, edited by Isaac Ghebre-Sellassie
38. Good Laboratory Practice Regulations, edited by Allen F. Hirsch
39. Nasal Systemic Drug Delivery, Yie W. Chien, Kenneth S.E. Su, and Shyi-Feu Chang
40. Modern Pharmaceutics: Second Edition, Revised and Expanded, edited by Gilbert S. Banker
and and Christopher T. Rhodes
41. Specialized Drug Delivery Systems: Manufacturing and Production Technology, edited by
Praveen Tyle
42. Topical Drug Delivery Formulations, edited by David W. Osborne and Anton H. Amann
43. Drug Stability: Principles and Practices, Jens T. Cartensen
44. Pharmaceutical Statistics: Practical and Clinical Applications, Second Edition, Revised and
Expanded, Sanford Bolton

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45. Biodegradable Polymers as Drug Delivery Systems, edited by Mark Chasin and Robert
Langer
46. Preclinical Drug Disposition: A Laboratory Handbook, Francis L.S. Tse and James J. Jaffe

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47. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong and Stanley K. Lam
48. Pharmaceutical Bioequivalence, edited by Peter G. Welling, Francis L.S. Tse, and Shrikant V.
Dinghe
49. Pharmaceutical Dissolution Testing, Umesh V. Banakar
50. Novel Drug Delivery Systems: Second Edition, Revised and Expanded, Yie W. Chien
51. Managing the Clinical Drug Development Process, David M. Cochetto and Ronald V. Nardi
52. Good Manufacturing Processes for Pharmaceuticals: A Plan for Total Quality Control, Third
Edition, edited by Sidney H. Willig and James R. Stoker
53. Prodrugs: Topical and Ocular Drug Delivery, edited by Kenneth B. Sloan
54. Pharmaceutical Inhalation Aerosol Technology, edited by Anthony J. Hickey
55. Radiopharmaceuticals: Chemistry and Pharmacology, edited by Adrian D. Nunn
56. New Drug Approval Process: Second Edition, Revised and Expanded, edited by Richard A.
Guarino
57. Pharmaceutical Process Validation: Second Edition, Revised and Expanded, edited by Ira R.
Berry and Robert A. Nash
58. Opthalmic Drug Delivery Systems, edited by Ashim K. Mitra
59. Pharmaceutical Skin Penetration Enhancement, edited by Kenneth A. Walters and Jonathan
Hadgraft
60. Colonic Drug Absorption and Metabolism, edited by Peter R. Bieck
61. Pharmaceutical Particulate Carriers: Therapeutic Applications, edited by Alain Rolland
62. Drug Permeation Enhancement: Theory and Applications, edited by Dean S. Hsieh
63. Glycopeptide Antibiotics, edited by Ramakrishnan Nagarajan
64. Achieving Sterility in Medical and Pharmaceutical Products, Nigel A. Halls
65. Mulitparticulate Oral Drug Delivery, edited by Isaac Ghebre-Sellasie
66. Colloidal Drug Delivery Systems, edited by Jörg Kreuter

67. Pharmacokinetics: Regulatory • Industrial • Academic Perspectives, Second Edition, edited by

Peter G. Welling and Francis L.S. Tse
68. Drug Stability: Principles and Practices, Second Edition, Revised and Expanded, Jens T.
Carstensen
69. Good Laboratory Practice Regulations: Second Edition, Revised and Expanded, edited by
Sandy Weinberg
70. Physical Characterization of Pharmaceutical Solids, edited by Harry J. Brittain
71. Pharmaceutical Powder Compaction Technology, edited by Göran Alderborn and Christer
Nyström

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72. Modern Pharmaceutics: Third Edition, Revised and Expanded, edited by Gilbert S. Banker
and Christopher T. Rhodes
73. Microencapsulation: Methods and Industrial Applications, edited by Simon Benita
74. Oral Mucosal Drug Delivery, edited by Michael J. Rathbone
75. Clinical Research in Pharmaceutical Development, edited by Barry Bleidt and Michael
Montagne
76. The Drug Development Process: Increasing Efficiency and Cost Effectiveness, edited by Peter
G. Welling, Louis Lasagna, and Umesh V. Banakar
77. Microparticulate Systems for the Delivery of Proteins and Vaccines, edited by Smadar Cohen
and Howard Bernstein
78. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Fourth
Edition, Revised and Expanded, Sidney H. Willig and James R. Stoker
79. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms: Second Edition, Revised and
Expanded, edited by James W. McGinity
80. Pharmaceutical Statistics: Practical and Clinical Applications, Third Edition, Sanford Bolton
81. Handbook of Pharmaceutical Granulation Technology, edited by Dilip M. Parikh
82. Biotechnology of Antibiotics: Second Edition, Revised and Expanded, edited by William R.
Strohl
83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Potts and Richard H. Guy
84. Pharmaceutical Enzymes, edited by Albert Lauwers and Simon Scharpé
85. Development of Biopharmaceutical Parenteral Dosage Forms, edited by John A. Bontempo
86. Pharmaceutical Project Management, edited by Tony Kennedy

87. Drug Products for Clinical Trials: An International Guide to Formulation • Production •
Quality Control, edited by Donald C. Monkhouse and Christopher T. Rhodes
88. Development and Formulation of Veterinary Dosage Forms: Second Edition, Revised and
Expanded, edited by Gregory E. Hardee and J. Desmond Baggot
89. Receptor-Based Drug Design, edited by Paul Leff
90. Automation and Validation of Information in Pharmaceutical Processing, edited by Joseph F.
deSpautz
91. Dermal Absorption and Toxicity Assessment, edited by Michael S. Roberts and Kenneth A.
Walters
92. Pharmaceutical Experimental Design, Gareth A. Lewis, Didier Mathieu, and Roger Phan-
Tan-Luu
93. Preparing for FDA Pre-Approval Inspections, edited by Martin D. Hynes III

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94. Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy, David E.
Bugay and W. Paul Findlay
95. Polymorphism in Pharmaceutical Solids, edited by Harry G. Brittain
96. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, edited by Louis Rey
and Joan C. May
97. Percutaneous Absorption: Drugs— Cosmetics— Mechanisms— Methodology, Third Edition,
Revised and Expanded, edited by Robert L. Bronaugh and Howard l. Maibach

ADDITIONAL VOLUMES IN PREPARATION

Transport Processes in Pharmaceutical Systems, edited by Gordon Amidon, Ping L Lee, and
Elizabeth M. Topp
Bioadhesive Drug Delivery Systems: Fundamentals, Novel Approaches, and Development, edited
by Edith Mathiowitz, Donald E. Chickering, and Claus-Michael Lehr
Peptide and Protein Drug Analysis, edited by Ronald E. Reid
Protein Formulation and Stability, edited by Eugene McNally
New Drug Approval Process: Third Edition, Revised and Expanded, edited by Richard A.
Guarino
Excipient Toxicity and Safety, edited by Myra Weiner and Lois Kotkoskie

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Page i

Freeze-Drying/Lyophilization of Pharmaceutical and

Biological Products
edited by
Louis Rey
Cabinet d É tudes
Lausanne, Switzerland

Joan C. May
Food and Drug Administration
Rockville, Maryland

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Page ii

ISBN: 0-8247-1983-2
This book is printed on acid-free paper.

Headquarters
Marcel Dekker, Inc.
270 Madison Avenue, New York, NY 10016
tel: 212-696-9000; fax: 212-685-4540

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tel: 41-61-261-8482; fax: 41-61-261-8896

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The publisher offers discounts on this book when ordered in bulk quantities. For more
information, write to Special Sales/Professional Marketing at the headquarters address above.

Copyright © 1999 by Marcel Dekker, Inc. All Rights Reserved.

Neither this book nor any part may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, microfilming, and recording, or by any
information storage and retrieval system, without permission in writing from the publisher.
Current printing (last digit):
10 9 8 7 6 5 4 3 2 1

PRINTED IN THE UNITED STATES OF AMERICA

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Page iii

Preface
Since its discovery by Altman at the turn of the century and its subsequent development by Gersh,
freeze-drying has been used for the preservation of delicate biologicals and biochemicals that
present a high instability at room temperature because of their important water content.
More or less considered a laboratory curiosity until the end of the 1930s, drying from the frozen
state underwent striking development during the last world war. Under the impetus of Earl
Flosdorf in the United States, Ronald Greaves in the United Kingdom, and François Henaff in
France, it became a routine technology for the preparation of blood plasma and plasma fractions,
which were of massive use on most battlefields and saved millions of lives throughout the world.
The process was then named lyophilization since it helped to prepare dry products with a great
affinity for their hydrated solvants. Later, the late Sir Ernst Boris Chain, Nobel Laureate, applied
freeze-drying for the first time for the preservation of the newly discovered penicillin, and less
than a decade later it became commonly used for the stabilization of vaccines, thanks to Charles
Merieux and his associates.
At the same time, on a purely engineering basis, extensive work was conducted in all major
developed countries to design and build large-scale reliable freeze-drying plants that were able to
handle batches of several tens— sometimes hundreds-of thousands of vials or ampoules in well-
controlled sterile conditions. In parallel, an important amount of basic research was conducted in
several laboratories to understand and monitor the freeze-drying process. Our own work in the
field started in 1954 and has been pursued ever since.
During that time, the scope of application of freeze-drying was opened to the food and chemical
industries, and new semicontinuous and even purely continuous processes developed for the
operations of large multitons/day plants.

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Page iv

However, as biological research evolved into the more sophisticated approach of physiological
biochemistry, and with the rocketing advance of genetical engineering, freeze-drying appeared in
most cases as a unique technique for the long-term perservation of very small amounts of highly
refined biological products. This, in turn, compelled most researchers to increase their knowledge
on the role and performances of bulking agents, additives, cryoprotectants, antioxidants, and free
radical scavengers, which were discovered to play a leading role in the protection of the integrity
of the active substances, during both freezing and drying as well as in the course of storage.
In that field, a better understanding of the behavior of complex molecules, such as proteins, during
lyophilization was acquired, as well as more and more information gathered on the leading role of
water in the whole process. The basic properties and the different ''states" of this critical
component of all living matter were studied with cutting-edge technologies such as X-ray and
neutron diffraction, nuclear paramagnetic resonance, or Debye dipolar absorption in addition to
the already classical tools of conventional physical chemistry. Concomitantly, the structure and
ultrastructure of freeze-dried products were investigated with direct or indirect technologies
ranging from classical to electron scanning microscopy, to more advanced methods such as
thermoluminescence.
The purpose of Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products is not
to present an exhaustive view of the process, but essentially to shed light on some focal areas of
the field in which pioneering research has been achieved and assess its impact on current
manufacturing practices. This book also provides a critical review of such wide issues as the
design and construction of equipment to identify the main trends and sometimes locate the specific
sectors where our technological know-how is still incomplete.
To the end, the editors have selected a group of knowledgeable experts who share a long
experience in the field and have a large understanding of the adjacent and complementary
disciplines. The contributors range from pure theoreticians to confirmed technicians with a wide
in-depth field practice. They agreed to present their views in a clear and comprehensive way,
avoiding unnecessary semantics and specialized mathematical treatments, in order to remain
readily accessible to the diversified group of potential users of freeze-drying in the pharmaceutical
industry. Special emphasis has been given to some grass-roots approaches to the process, which
are of basic importance for operators and can also incline theoreticians to take a closer look into
the actual unfolding of lyophilization.
The editors hope that this somewhat unconventional approach to freeze-drying will be of interest
and help not only for those who plan to enter this area, but also to the great majority of the
experienced operators who wish to better understand the odds and ends of a challenging process.
LOUIS REY

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Page v

Contents

Preface iii

Contributors vii

1. Glimpses into the Realm of Freeze-Drying: Classical Issues and New 1

Ventures
Louis Rey

2. Potential Energy Surfaces, Computer Simulations, and the Structure of 31

Water
Robert O. Watts

3. Structural and Dynamic Properties of Bulk and Confined Water 53

Marie-Claire Bellissent-Funel And José Teixeira

4. Experimental Freeze-Drying: Procedures and Equipment 79

Hanna Willemer

5. Freezing- and Drying-Induced Perturbations of Protein Structure and 123

Mechanisms of Protein Protection by Stabilizing Additives
John F. Carpenter, Ken-ichi Izutsu, And Theodore W Randolph

6. Mechanisms of Protein Stabilization During Freeze-Drying and Storage: 161

The Relative Importance of Thermodynamic Stabilization and Glassy State
Relaxation Dynamics
Michael J. Pikal

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Page vi

7. Regulatory Control of Freeze-Dried Products: Importance and Evaluation 199

of Residual Moisture
Joan C. May

8. Basic Aspects and Industrial Strategies for the Preservation of 231

Microorganisms by Freezing and Drying
Hiroshi Souzu

9. Industrial Freeze-Drying for Pharmaceutical Applications 267

Georg-Wilhelm Oetjen

10. Industrial Freeze-Drying of Vaccines Destined for Veterinary Purposes: 337

An Overview
Pierre Precausta, Noel Genin, Gérard Bénet, And Nicolas Tourneur

11. Manufacturing Principles of Freeze-Dried Collagen Sponges: 359

Characteristics and Applications
Petra Tewes-Schwarzer

12. Lyophilization Process Validation 373

Christian Bindschaedler

13. Critical Steps in the Preparation of Elastomeric Closures for 409

Biopharmaceutical Freeze-Dried Products
Maninder S. Hora And Sidney N. Wolfe

14. Technical Procedures for Operation of Cleaning-in-Place and 423

Sterilization-in-Place Process for Production Freeze-Drying Equipment
Gilles A. Beurel

15. Studies on Development of Manufacturing Processes for Pharmaceutical 433

Freeze-Dried Products
Yusuke Suzuki, Yutaka Sumi, And Taiichi Mizuta

16. Potential Prospects in Freeze-Drying 465

Louis Rey

Index 473

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Page vii

Contributors
Marie-Claire Bellissent-Funel, Ph.D. Director of Research, Léon-Brillouin Laboratory, CNRS,
Gif-sur-Yvette, France

Gérard Bénet, Ph.D. Associate Director, Pilot Department, Merial SAS, Lyon, France

Gilles A. Beurel General Manager, S.G.D. Serail, Argenteuil, France

Christian Bindschaedler, Ph.D. Project Manager, Process Support, Serono Laboratories S.A.,
Aubonne, Switzerland

John F. Carpenter, Ph.D. Associate Professor, Department of Pharmaceutical Sciences, School

of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado

Noël Genin, Ph.D. Associate Manager, Pilot Department, Merial SAS, Lyon, France

Maninder S. Hora, Ph.D. Senior Director, Department of Formulation Development, Chiron

Corporation, Emeryville, California

Ken-ichi Izutsu, Ph.D. Department of Pharmaceutical Sciences, School of Pharmacy, University

of Colorado Health Sciences Center, Denver, Colorado

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Page viii

Joan C. May, Ph.D. Director, Laboratory of Analytical Chemistry, Center for Biologics
Evaluation and Research, Food and Drug Administration, Rockville, Maryland

Taiichi Mizuta, Ph.D. Director and Senior General Manager, Manufacturing Division, Shionogi
& Co. Ltd., Hyogo, Japan

Georg-Wilhelm Oetjen, Ph.D. Chemical Engineering Consultant, Lübeck, Germany

Michael J. Pikal, Ph.D. Professor of Pharmaceutics, Department of Pharmaceutical Science,

School of Pharmacy, University of Connecticut, Storrs, Connecticut

Pierre Precausta, D.V.M. Merial SAS, Lyon, France

Theodore W. Randolph, Ph.D. Associate Professor, Department of Chemical Engineering,

University of Colorado, Boulder, Colorado

Louis Rey, Ph.D. Professor Emeritus, Scientific Advisor, Cabinet d'É tudes, Lausanne,
Switzerland

Hiroshi Souzu, Ph.D. Professor, Institute of Low Temperature Science, Hokkaido University,
Sapporo, Japan

Yutaka Sumi General Manager, Formulation and Packaging Technical Services Department,
Shionogi & Co. Ltd., Hyogo, Japan

Yusuke Suzuki, Ph.D. Senior Researcher and Deputy General Manager, Formulation Research
and Development Laboratories, Shionogi & Co. Ltd., Hyogo, Japan

José Teixeira, Ph.D. Director of Research, Léon-Brillouin Laboratory, CNRS, Gif-sur-Yvette,

France

Petra Tewes-Schwarzer Department of Research and Development, Dr. Suwelack Skin and
Health Care AG, Billerbeck, Germany

Nicolas Tourneur Associate Director, Manufacturing Department, Merial SAS, Lyon, France

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Page ix

Robert O. Watts, Ph.D.* Professor, School of Chemistry, University of Melbourne, Parkville,

Victoria, Australia

Hanna Willemer Consultant, Köln, Germany

Sidney N. Wolfe Principal Scientist, Department of Formulation Development, Chiron

Corporation, Emeryville, California
*Current affiliation: Chief Scientist, Melbourne Laboratories, The Broken Hill Proprietary Company
Limited, Mulgrave, Victoria, Australia.

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