Process Scale Purification of Antibodies (eBook)

Uwe Gottschalk, PhD,is Chief Technology Officer at Lonza Pharma/Biotech, Switzerland. Previously, he served as Group Vice President at Sartorius Stedim Biotech (2004-2014) and in various development and manufacturing capacities at Bayer Health Care (1991-2004). Dr. Gottschalk received a doctorate in chemistry from the University of Münster (Germany) for work on antibody-drug conjugates at the Cancer Research Campaign Laboratories in Nottingham (UK). He is Head Lecturer at the University of Duisburg-Essen, Germany, and has written extensively in the areas of industrial biotechnology and somatic gene therapy.

List of Contributors

Preface

Chapter 1. Introduction
Elizabeth Kwong

1.1 Overcoming Challenges in big pharma and evolution of start-ups

1.2 Overview of activities involved in current drug discovery and development

1.3 Value of the right formulation at the right time

References

Chapter 2: Lead identification/optimization
DR MEI WONG AND DR MARK MCALLISTER

2.1 Introduction

2.2 Early characterization of compounds

2.3 Formulation approaches in drug discovery

2.4 Conclusion

References

Chapter 3 : Oral Drug Formulation Development In Pharmaceutical Lead Selection Stage
SHAYNE COX GAD, PH.D., D.A.B.T., ATS

3.1 Introduction

3.2 Formulation Considerations in Lead Selection Stage

3.3 Formulation Supporting Toxicology Studies

3.4 Technique of oral administration

3.5 Concluding Remarks

References

Chapter 4: Bridging End Of Discovery To Regulatory Filing: Formulations For IND- And Registration-Enabling Nonclinical Studies
Evan A. Thackaberry, Ph.D., D.A.B.T., Genentech, Inc.

4.1 Introduction

4.2 Formulation Selection for GLP Nonclinical Safety Studies

4.3 Dose Selection and Test Article Requirements for Nonclinical Toxicology Studies

4.4 Phase Appropriate Nonclinical Formulation Strategy

4.5 Methods of Test Article Administration

4.6 Formulation Tolerability across Species and Study Designs

4.7 The relationship between clinical and nonclinical formulations

4.8 Conclusions

References

Chapter 5: Planning The First Clinical Trials With Clinical Manufacturing Organization (CMO)
Elizabeth Kwong, Ph.D. and Caroline McGregor, Ph.D.

5.1 Reasons for Outsourcing

5.2 Considerations for Outsourcing

5.3 Timing of CMO selection

5.4 Pre-CMO selection Background information/preparation

5.5 Selection of CMO

5.6 Final thoughts

5.7 Abbreviations

References

Chapter 6: Formulation Strategies for High Dose Toxicology Studies: Case Studies
Dennis H. Leung, Pierre Daublain, Mengwei Hu, Kung-I Feng

6.1 ntroduction

6.2 General

6.3 Nanosuspension Formulation

Case Study 1 - Nanosuspension Formulation for Increased Maximum Dose and Systemic Drug Exposure

6.4 Amorphous Solid Dispersion Formulations

Case Study 2 - Amorphous Solid Dispersion Formulation for Resolving Complex Polymorphism Challenges

Case Study 3 - Amorphous Solid Dispersion Formulation for Improving Oral Absorption

Reference

Chapter 7: Formulation, Analytical And Regulatory Strategies For First In Human Clinical Trials
Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden and Steven Booth

7.1 INTRODUCTION

7.2 PLANNING AND EXECUTING THE FIH TRIAL

7.3 FORMULATION DEVELOPMENT

7.4 ANALYTICAL DEVELOPMENT

7.5 INFORMATION NEEDED IN PREPARATION OF REGULATORY SUBMISSION

7.6 CONCLUSIONS

Reference

Index