PART 1 INTRODUCTION<br>Biopharmaceutical Production: Value Creation, Product Types and Biological Basics<br>PART 2 TECHNOLOGY<br>Manufacturing Process<br>Analytics<br>PART 3 PHARMACY<br>Pharmacology and Drug Safety<br>PART 4 QUALITY ASSURANCE<br>Fundamentals of Quality Assurance<br>Quality Assurance in Manufacturing<br>Appendix A: Case Study Part IV: Warning Letters by FDA<br>PART 5 PHARMACEUTICAL LAW<br>Pharmaceutical Law and Regulatory Authorities<br>Appendix B: Case Study Part V: Clinical Trials for Protein Products<br>PART 6 PRODUCTION FACILITIES<br>Facility Design<br>Planning, Construction and Commissioning of a Manufacturing Plant<br>PART 7 ECONOMY<br>Production Costs<br>Investments<br>Production Concept<br>Appendix C: Examples Part VII: Manufacturing Cost <br>Part 8 PRODUCTION ORGANISATION AND DIGITALIZATION<br>13 Organisation and Core Processes of a Manufacturing Facility<br>14 Digitalization<br> <br>