Chapter 3 Current good manufacturing practice (CGMP) for biopharmaceutical production

Chapters in this book

1. Frontmatter I
2. Preface to the second edition V
3. Contents VII
4. Chapter 1 An introduction to biopharmaceutical products 1
5. Chapter 2 An overview of processes and facilities for biopharmaceutical production 25
6. Chapter 3 Current good manufacturing practice (CGMP) for biopharmaceutical production 64
7. Chapter 4 Upstream operations 95
8. Chapter 5 Harvest operations, part 1: cell lysis 131
9. Chapter 6 Harvest operations, part 2: solid-liquid separation by centrifugation 154
10. Chapter 7 Harvest operations, part 3: solid-liquid separation by filtration 180
11. Chapter 8 Purification operations: chromatography 208
12. Chapter 9 Formulation operations: ultrafiltration 256
13. Chapter 10 Summary and trends in biopharmaceutical processing 296
14. Glossary 301
15. References 315
16. Index 331