Process Architecture in Biomanufacturing Facility Design.

Intro -- Title Page -- Copyright -- Table of Contents -- Dedication -- Contributors -- Foreword -- Preface: Why a Book on Process Architecture? -- Chapter 1: Introduction to Biomanufacturing -- 1.1 Introduction -- 1.2 The Basic Constituents of Biopharmaceuticals -- 1.3 Enterprise Element #1-Manufacturing Processes -- 1.4 Enterprise Element #2-Manufacturing Facility -- 1.5 Enterprise Element #3-Manufacturing Infrastructure -- 1.6 Controlling the Manufacturing Enterprise -- 1.7 Summary -- References -- Chapter 2: Product-Process-Facility Relationship -- 2.1 Introduction -- 2.2 The Characteristics of Biological Therapeutic Products -- 2.3 Understanding the Attributes -- 2.4 Factors that Impact Facility Design -- References -- Chapter 3: Regulatory Considerations of Biomanufacturing Facilities -- 3.1 Introduction -- 3.2 Regulatory "Uncertainty," A Two-Way Street -- 3.3 Design with the Patient in Mind: Assess the Patient, Product, Process, and Plant -- 3.4 Laws, Regulations, and Guidelines: Historical Background -- 3.5 Global Guidance Documents -- 3.6 Quality Systems and Risk Management -- 3.7 Product Changeover and Regulatory Assessment of Cleaning Validation -- 3.8 Control Strategy -- 3.9 Contract Manufacturing Organizations -- 3.10 FDA Inspections of Biopharm Facilities and Regulators' Priorities -- 3.11 Regulatory Meetings -- 3.12 Conclusion -- References -- Chapter 4: Biopharmaceutical Facility Design and Validation -- 4.1 Introduction -- 4.2 Designing for Compliance -- 4.3 Risk Management -- 4.4 Qualification/Verification -- 4.5 Process Validation -- 4.6 List of Abbreviations -- References -- Chapter 5: Closed Systems in Bioprocessing -- 5.1 Introduction -- 5.2 Definition of Closed Systems -- 5.3 Closed System Design -- 5.4 Impact on Facility Design -- 5.5 Impact on Operations -- 5.6 Summary -- References.

Chapter 6: Aseptic Manufacturing Considerations for Biomanufacturing Facility Design -- 6.1 Introduction -- 6.2 The Relationship to Biological Products -- 6.3 Process Attributes-Product Protection -- 6.4 Facility Design -- 6.5 Critical Area -- References -- Chapter 7: Facility Control of Microorganisms: Containment and Contamination -- 7.1 Introduction -- 7.2 Design Principles for Controlling Microorganisms -- 7.3 Controlling Viable Environmental Particulates -- 7.4 Reducing the Transport of Mold into the Bioprocess Facility -- 7.5 Reducing Mold Sources within the Bioprocess Facility -- 7.6 Biocontainment: An Overlay to Process Design -- 7.7 The Biocontainment Regulatory Environment -- 7.8 Principles of Biosafety -- 7.9 Principles of Biocontainment Facility Design -- 7.10 Design for the Entire Process -- 7.11 Conclusion -- References -- Further Reading -- Chapter 8: Process-Based Laboratory Design -- 8.1 Introduction -- 8.2 Areas of Application/Scope -- 8.3 Translation of Process Elements into Laboratory Architecture -- 8.4 Key Steps in Planning Approach and Methodology -- 8.5 Laboratory Concept Development -- 8.6 SHE Considerations -- 8.7 Glossary -- 8.8 List of Abbreviations -- References -- Chapter 9: Case Study: Pharmaceutical Pilot Plant Design and Operation -- 9.1 Introduction -- 9.2 Operational Concepts and Processing Requirements -- 9.3 Design -- 9.4 Operation -- References -- Chapter 10: Addressing Sustainability in Biomanufacturing Facility Design -- 10.1 Introduction -- 10.2 Process Architecture -- 10.3 Water and Water Treatment -- 10.4 Energy Efficiency -- 10.5 Conclusion -- Acknowledgments -- References -- Chapter 11: Technology's Impact on the Biomanufacturing Facility of the Future -- 11.1 Introduction -- 11.2 The Enabling Technologies -- 11.3 Elements of a Biomanufacturing Enterprise -- 11.4 Evolution of the Facility of the Future.

11.5 The Future-Summary and Conclusions -- References -- Glossary -- Index -- End User License Agreement.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.