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

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

List of ContributorsPrefaceChapter 1. IntroductionElizabeth Kwong1.1 Overcoming Challenges in big pharma and evolution of start-ups1.2 Overview of activities involved in current drug discovery and development1.3 Value of the right formulation at the right timeReferencesChapter 2: Lead identification/optimizationDR MEI WONG AND DR MARK MCALLISTER2.1 Introduction2.2 Early characterization of compounds2.3 Formulation approaches in drug discovery2.4 ConclusionReferencesChapter 3 : Oral Drug Formulation Development In Pharmaceutical Lead Selection StageSHAYNE COX GAD, PH.D., D.A.B.T., ATS3.1 Introduction3.2 Formulation Considerations in Lead Selection Stage3.3 Formulation Supporting Toxicology Studies3.4 Technique of oral administration3.5 Concluding RemarksReferencesChapter 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 Introduction4.2 Formulation Selection for GLP Nonclinical Safety Studies4.3 Dose Selection and Test Article Requirements for Nonclinical Toxicology Studies4.4 Phase Appropriate Nonclinical Formulation Strategy4.5 Methods of Test Article Administration4.6 Formulation Tolerability across Species and Study Designs4.7 The relationship between clinical and nonclinical formulations4.8 ConclusionsReferencesChapter 5: Planning The First Clinical Trials With Clinical Manufacturing Organization (CMO)Elizabeth Kwong, Ph.D. and Caroline McGregor, Ph.D.5.1 Reasons for Outsourcing5.2 Considerations for Outsourcing5.3 Timing of CMO selection5.4 Pre-CMO selection Background information/preparation5.5 Selection of CMO5.6 Final thoughts5.7 AbbreviationsReferencesChapter 6: Formulation Strategies for High Dose Toxicology Studies: Case StudiesDennis H. Leung, Pierre Daublain, Mengwei Hu, Kung-I Feng6.1 ntroduction6.2 General6.3 Nanosuspension FormulationCase Study 1 - Nanosuspension Formulation for Increased Maximum Dose and Systemic Drug Exposure6.4 Amorphous Solid Dispersion FormulationsCase Study 2 - Amorphous Solid Dispersion Formulation for Resolving Complex Polymorphism ChallengesCase Study 3 - Amorphous Solid Dispersion Formulation for Improving Oral AbsorptionReferenceChapter 7: Formulation, Analytical And Regulatory Strategies For First In Human Clinical TrialsLorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden and Steven Booth7.1 INTRODUCTION7.2 PLANNING AND EXECUTING THE FIH TRIAL7.3 FORMULATION DEVELOPMENT7.4 ANALYTICAL DEVELOPMENT7.5 INFORMATION NEEDED IN PREPARATION OF REGULATORY SUBMISSION7.6 CONCLUSIONSReferenceIndex