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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
Attention for Chapter 23: Chapter 23: Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade Filtration
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Chapter title
Chapter 23: Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade Filtration
Chapter number 23
Book title
Development of Biopharmaceutical Drug-Device Products
Published by
Springer, Cham, March 2020
DOI 10.1007/978-3-030-31415-6_23
Book ISBNs
978-3-03-031414-9, 978-3-03-031415-6
Authors

Christine Rinn, Michael Siedler

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 2 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 2 100%

Demographic breakdown

Readers by professional status Count As %
Unspecified 1 50%
Unknown 1 50%
Readers by discipline Count As %
Unspecified 1 50%
Unknown 1 50%