バイオ医薬品製造プロセス・ハンドブック Biopharmaceutical Processing : Development, Design, and Implementation of Manufacturing Processes

Jagschies, Gunter (EDT)/ Lindskog, Eva (EDT)/ Lacki, Karol (EDT)

Elsevier / The Lancet（2017/12発売）

• 製本 Hardcover:ハードカバー版／ページ数 1308 p.
• 言語 ENG
• 商品コード 9780081006238
• DDC分類 615.19

Full Description

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry.

The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry.

Contents

1. Overview of Biotherapeutics and Vaccine Industry 2. Industrial Process Design Concepts 3. Single-Use Concepts in Manufacturing 4. Equipment and Automation 5. Facility Design 6. Process Development Routines 7. Production Sources and their Selection 8. Upstream Processing 9. Downstream Processing 1: Recovery Process 10. Downstream Processing 2: Purification Process 11. Downstream Related Methods 12. Analytics 13. Regulatory Aspects 14. Manufacturing Operations 15. Economics