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Development of Biopharmaceutical Drug-Device Products

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Cover of 'Development of Biopharmaceutical Drug-Device Products'

Table of Contents

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    Book Overview
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    Chapter 1 Chapter 1: Monoclonal Antibodies: Structure, Physicochemical Stability, and Protein Engineering
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    Chapter 2 Chapter 2: Challenges and Considerations in the Design of Antibody-Drug Conjugates
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    Chapter 3 Chapter 3: Enabling Biologics Combination Products: Device Ability in Protein Therapeutics
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    Chapter 4 Chapter 4: Production Strategies and Challenges with IgG-Based Bispecific Ab Formats
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    Chapter 5 Chapter 5: Lessons Learned in Understanding Dual Variable Domain-Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates
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    Chapter 6 Chapter 6: High-Throughput Conformational and Colloidal Stability Screening of Biologic Molecules
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    Chapter 7 Chapter 7: An Empirical Phase Diagram: High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals
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    Chapter 9 Chapter 9: Leveraging the Multi-attribute Method (MAM) to Improve Biotherapeutic Development
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    Chapter 10 Chapter 10: Analytical Methods for Antibody Drug Conjugate Characterization
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    Chapter 11 Chapter 11: Particles in Biopharmaceuticals: Causes, Characterization, and Strategy
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    Chapter 12 Chapter 12: Strategies in the Development of Formulations for Antibody-Based Therapeutics
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    Chapter 14 Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products
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    Chapter 15 Chapter 15: Drug Product Formulation Development and Formulation Robustness Criteria for a mAb in a Pre-filled Syringe
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    Chapter 16 Chapter 16: Development of Robust Lyophilization Process for Therapeutic Proteins: A Case Study
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    Chapter 18 Chapter 18: Design of Clinical In-Use Studies
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    Chapter 20 Chapter 20: Freeze-Thaw Process Data Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill Volumes
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    Chapter 21 Chapter 21: Rational Design of a Freeze-Drying Process for Protein Products
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    Chapter 22 Chapter 22: Development and Scale-Up of the Mixing Process for Biopharmaceuticals
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    Chapter 23 Chapter 23: Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade Filtration
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    Chapter 24 Chapter 24: Considerations and Challenges When Filling High-Concentration Monoclonal Antibody Formulations into Prefilled Syringes
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    Chapter 26 Chapter 26: Development Challenges and Opportunities for Drug/Device Combination Products
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    Chapter 27 Chapter 27: Evolving Regulatory Landscape for Combination Products: US Perspective
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    Chapter 28 Chapter 28: Evolving Regulatory Landscape for Drug-Device Combination Products: Europe and Other Major Market Perspectives
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    Chapter 29 Chapter 29: Importance of Design Control and Risk Management Processes in Combination Product Development
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    Chapter 30 Chapter 30: Standards for Injectable Delivery Devices: ISO 11608 Series and Others
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    Chapter 32 Chapter 32: A Science and Risk-Based Approach to Bridging Drug-Device Combination Products
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    Chapter 33 Chapter 33: Design and Development Considerations for Autoinjector Delivery Systems: Technology Developer and Industry Perspectives
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    Chapter 36 Chapter 36: Considerations in the Development, Approval, and Commercialization of On-Body Delivery Devices Used in Combination with a Biologic
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Title
Development of Biopharmaceutical Drug-Device Products
Published by
Springer International Publishing, January 2020
DOI 10.1007/978-3-030-31415-6
ISBNs
978-3-03-031414-9, 978-3-03-031415-6
Editors

Feroz Jameel, John W. Skoug, Robert R. Nesbitt

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 22 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 6 27%
Other 3 14%
Student > Bachelor 2 9%
Student > Master 2 9%
Researcher 2 9%
Other 0 0%
Unknown 7 32%
Readers by discipline Count As %
Biochemistry, Genetics and Molecular Biology 4 18%
Chemical Engineering 3 14%
Engineering 3 14%
Pharmacology, Toxicology and Pharmaceutical Science 2 9%
Agricultural and Biological Sciences 1 5%
Other 3 14%
Unknown 6 27%