Introduction to Biomanufacturing Textbook

The Northeast Biomanufacturing Center and Collaborative (NBC2) has created this introductory textbook on Biomanufacturing that features fifteen industry subject matter expert-authored units. Chapters cover Facilities, Metrology, Validation, Environmental Health & Safety, Operational Excellence, Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, Manufacture of a Drug Product, and Biofuels. Individual chapters are included in this zip file and may be read online or downloaded.

Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis.

Intro to Biomanufacturing (32 files 19.4 MB)

• Appendix A: Master Glossary (22886923819658983-masterglossary-restricted.pdf 499 KB)
• Chapter 1: Introduction (201954429735501318-chapter-1.pdf 1.1 MB)
• Engineering Unit
  • Chapter 2: Facilities (212662612262892472-chapter-2.pdf 1.4 MB)
  • Chapter 3: Metrology (428913965273528624-chapter-3.pdf 753 KB)
  • Chapter 4: Validation (595781148110118460-chapter-4.pdf 1.0 MB)
  • Chapter 5: Environmental, Health, and Safety (EHS) (859297584164794215-chapter-5.pdf 926 KB)
  • Chapter 6: Operational Excellence (526768624190252973-chapter-6.pdf 1.1 MB)
  • Overview: Engineering Unit (973277756482382945-engineering-unit-overview.pdf 395 KB)
• Manufacture of a Drug Product Unit
  • Chapter 13: Formulation Development of Parenteral Products (412281068225186100-chapter-13.pdf 1.1 MB)
  • Chapter 14: Sterile Filtration, Filling, and Lyophilization of Product (340852170209494547-chapter-14.pdf 3.4 MB)
  • Chapter 15: Inspection, Labeling, and Packaging (786663053239827062-chapter-15.pdf 1.2 MB)
  • Overview: Development and Manufacturing of Parenteral Drug Products Unit (415012439718787915-drug-product-unit-overview.pd 337 KB)
• Production Unit
  • Chapter 10: Upstream Processing (452459198388198903-chapter-10.pdf 1.2 MB)
  • Chapter 11: Downstream Processing (729676066278425576-chapter-11.pdf 1.1 MB)
  • Chapter 12: Process Development (701306457399630057-chapter-12.pdf 542 KB)
  • Overview: Production Unit (581437647761393013-production-unit-overview.pdf 430 KB)
• Quality Unit
  • Overview: Quality (84895790614231225-quality-unit-overview.pdf 404 KB)
  • Chapter 7: Quality Assurance (380009860690819115-chapter-7.pdf 681 KB)
  • Chapter 8: Microbiological Control (537288293383421006-chapter-8.pdf 1.2 MB)
  • Chapter 9: Quality Control Biochemistry (154400045737427643-chapter-9.pdf 688 KB)