List of Tables

iv

List of Figures

vi

Foreword

viii

CHAPTER 1: The Therapeutic Monoclonal Antibody Market

1

CHAPTER 2: Overview of Chemistry, Manufacturing, and Control Activities for Monoclonal Antibody Product Development

33

CHAPTER 3: Quality by Design

65

CHAPTER 4: Analytical Development

95

CHAPTER 5: Cell Line Development and Engineering

155

CHAPTER 6: Cell Culture Development and Scale-up

195

CHAPTER 7: Purification Development

241

CHAPTER 8: Formulation Development and Stability

313

CHAPTER 9: Drug Product Manufacturing

370

CHAPTER 10: Comparability

393

CHAPTER 11: Process Validation

423

CHAPTER 12: Manufacturing Strategies

473