Quality by design for biopharmaceutical drug product development. (2015)

• Record Type: Book
• Further Information: Note: Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, editors.
• Editors: Jameel, Feroz; Hershenson, Susan; Khan, Mansoor A; Martin-Moe, Sheryl
• 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.
• Publisher Details: New York, NY : Springer
• Publication Date: 2015
• Extent: 1 online resource (xx, 710 pages), illustrations (some color)
• Subjects: 615.1/9; Medicine; Pharmaceutical biotechnology; Drug development; MEDICAL -- Pharmacology; Drug development; Pharmaceutical biotechnology; Drug Compounding; Pharmaceutical Preparations -- standards; Quality Control; Technology, Pharmaceutical; Biopharmaceutics; Drug Discovery; Medical -- General; Medical research; Toxicology; Pharmacology; Electronic books
• Languages: English
• ISBNs: 9781493923168; 1493923161; 1493923153; 9781493923151
• Related ISBNs: 9781493923151
• Notes: Note: Includes bibliographical references at the end of each chapters and index.; Note: Online resource; title from PDF title page (SpringerLink, viewed April 8, 2015).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.