Promoting a continued and much–needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top–tier technology experts to address the challenges of antibody purification. Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton–scale manufacturing Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification Emphasizes antibodies and innovative chromatography methods for processing INDICE: List of Contributors .Preface .Chapter 1. IntroductionElizabeth 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/optimizationDR 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 StageSHAYNE 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 StudiesEvan 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 StudiesDennis 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 TrialsLorenzo 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
- ISBN: 978-1-119-12691-1
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 752
- Fecha Publicación: 03/05/2017
- Nº Volúmenes: 1
- Idioma: Inglés