Quality by Design for Biopharmaceutical Drug Product Development
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these element...
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| Other Authors: | , , , |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
New York, NY :
Springer New York : Imprint: Springer,
2015.
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| Edition: | 1st ed. 2015. |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series,
18 |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/978-1-4939-2316-8 |
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Table of Contents:
- 1 Challenges and Opportunities for Biotech Quality by Design
- 2 Lessons Learned From Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program
- 3 Definitions and Scope of Key Elements of QbD
- 4 An Overview of Quality by Design for Drug Product
- 5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening
- 6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations
- 7 Application of QbD Principles to Late-stage Formulation Development for Biological Liquid Products
- 8 Application of QbD Principles for Lyophilized Formulation Development
- 9 Drug Substance Frozen Storage and Thawing
- 10 Quality by Design as Applied to Drug Substance Formulation using Ultrafiltration and Diafiltration
- 11 A QbD Approach in the Development and Scale-up of Mixing Processes
- 12 Application of QbD Elements in the Development and Scale-up of a Commercial Filtration Process
- 13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process
- 14 Lyophilization Process Design and Development Using QbD Principles
- 15 Visible and Subvisible Protein Particle Inspection Within a QbD-based Strategy
- 16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products
- 17 Quality by Design for Primary Container Components
- 18 Devices and Combination Products for Biopharmaceuticals
- 19 Applicability of QbD for Vaccine Drug Product Development
- 20 Automation and High Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches
- 21 Critical Quality Attributes, Specifications, and Control Strategy
- 22 Multivariate Analysis for Process Understanding, Monitoring, Control and Optimization in Lyophilization Processes
- 23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-drying Processes
- 24 Application of Multivariate Statistical Process Monitoring to Lyophilization Process
- 25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process
- 26 Product Homogeneity Assessment during Validation of Biopharmaceutical Drug Product Manufacturing Processes
- 27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process
- 28 Regulatory Considerations For Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.