| 序号 | 章节 | 页码 | 认领人 |
| 1 | 1 | Introduction
1.1 Background.
1.2 Purpose
1.3 Scope
1.4 Key ConceptsStructure | 9-12 | |
| 2 | 2.1-2.3 | Regulatory Considerations for Biopharmaceutical Process Development and Manufacturing
2.1 Introduction
2.2 Regulatory Organizations
2.3 Specific GMP Regulatory Requirements for Non-US Markets and Non-US Manufacturing Locations
2.4 Relationship to ICH Guidance Documents
2.5 Regulatory Considerations Across the Product Life Cycle
2.6 Differences Between the EU and FDA Approaches to Risk | 13-23 | |
| 3 | 2.4-2.6 | 23-27 | |
| 4 | 3 | Biopharmaceutical Processes, General
3.1 Introduction
3.2 Stages of Biopharmaceutical Product Development
3.3 Overview of the Regulatory Implications of Quality by Design and Quality Risk Management
3.4 Stability | 29-44 | |
| 5 | 4 | Upstream Unit Operations
4.1 Cell Line Development
4.2 Cell Bank Preparation, Validation, and Maintenance
4.3 Fermentation and Cell Culture
4.4 Media Systems
4.5 Clarification and Recovery | 45-52 | |
| 6 | 5.1-5.5 | Downstream Processing Unit Operations
5.1 Overview of Downstream Processing
5.2 Filtration in Downstream Processing
5.4 Viral Clearance
5.5 Biopharmaceutical and Vaccine Conjugation
5.6 Bulk Formulation and Filling
5.7 Buffer Preparation and Storage
5.8 Special Topics | 63-76 | |
| 7 | 5.6-5.8 | 76-86 | |
| 8 | 6 | Scale-Up and Technology Transfer
6.1 Introduction
6.2 Scale-Up General Considerations
6.3 Upstream Scale-Up
6.4 Primary Recovery
6.5 Chromatography
6.6 Ultrafiltration/Diafiltration (UF/DF)
6.7 Technology Transfer | 87-101 | |
| 9 | 7 | Process Support and Utility Systems
7.1 Introduction
7.2 Regulatory Guidance
7.3 Materials of Construction
7.4 System Layout and Routing
7.5 Specific Service Considerations
7.6 Pharmaceutical Water
7.7 Pharmaceutical Steam
7.8 Equipment Cleaning
7.9 Process and Utility Gases
7.10 Process Temperature Control Systems
7.11 Cryogenics and Process Cooling
7.12 Process Bio-Waste Handling
7.13 Drains and Waste Collection
7.14 Potable Water Systems
7.15 Vacuum Systems
7.16 Electrical Services | 103-116 | |
| 10 | 8 | Process Impact on Facilities
8.1 Introduction
8.2 Process Considerations
8.3 Application of Risk Assessment to Facility Design
8.4 Impact of Operational Philosophy and Process Definition on Facility Design
8.5 The Impact of Closed System Process Design on Facility Design
8.6 Automation and Control Philosophy Impacts on Facility Design
8.7 Pilot Plant Items for Consideration | 117-134 | |
| 11 | 9 | Non-US Manufacturing and Non-FDA Regulated
Market Requirements
9.1 Introduction
9.2 Occupational Health and Safety Regulatory Organizations and Standards
9.3 Environmental Regulatory Organizations and Standards
9.4 Specific GMP Regulatory Requirements for Non-US Markets and Non-US Manufacturing Locations..... 140
9.5 Residual DNA
9.6 Drug Development and Clinical Trials
9.7 Specific Safety Requirements for Non-US Manufacturing Locations
9.8 Environmental Aspects Specifically Related to Biopharmaceutical Processing
9.9 Particular Engineering Items Affecting Bio-Equipment and Process Systems Design
9.10 General Commentary on Specific Environmental Health and Safety Issues | 136-148 | |
| 12 | 10 | Equations
10.1 Growth Curve Equation for Batch Fermentations
10.2 Design Equations for a Fermentation System | 150-154 | |
| 13 | 11.1-11.4 | Detailed Information
11.1 Bacterial and Mammalian Cell Types
11.2 Stirred Tank Reactor Scale-Up
11.3 Cell Disruption
11.4 Homogenization
11.5 CentrifugationFiltration
11.7 Chromatography Operations | 156-165 | |
| 14 | 11.5-11.6 | 166-184 | |
| 15 | 11.7 | 184-195 | |
| 16 | 12 | References不翻译 |
| 17 | 13 | Glossary | 208-224 | |
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发表于 2016-3-16 10:56:12
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