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Home / Curriculum Resources / Textbooks & Manuals

Introduction to Biomanufacturing

Introduction to Biomanufacturing is the first comprehensive textbook on biomanufacturing. Featuring fifteen industry SME-authored chapters, Introduction to Biomanufacturing provides an in-depth look at all facets of biomanufacturing.

Individual chapters from Introduction to Biomanufacturing are free to download, and can be found within the Program Units page and by clicking the links below.

Introduction uNIT

Chapter 1: Introduction to Biomanufacturing

Engineering Unit
Engineering Unit Overview
Chapter 2: Facilities
Chapter 3: Metrology
Chapter 4: Validation
Chapter 5: Environmental Health & Safety
Chapter 6: Operational Excellence
Quality Unit
Quality Unit Overview
Chapter 7: Quality Assurance
Chapter 8: Microbiological Control
Chapter 9: Quality Control Biochemistry
Production Unit
Production Unit Overview
Chapter 10: Upstream Processing
Chapter 11: Downstream Processing
Chapter 12: Process Development
Manufacture of a Drug Product Unit
Manufacture of a Drug Product Unit Overview
Chapter 13: Formulation Development of Parenteral Products
Chapter 14: Sterile Filtration, Filling, and Lyophilization of Product
Chapter 15: Inspection, Labeling and Packaging
Introduction to Biomanufacturing Master Glossary