Protein instability at interfaces during drug product development : fundamental understanding, evaluation, and mitigation / Jinjiang Li, Mary E. Krause, Raymond Tu, editors.
Li, Jinjiang, author.; Krause, Mary E., author.; Tu, Raymond, author.
2021
RM301.25
Available Online

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Title Protein instability at interfaces during drug product development : fundamental understanding, evaluation, and mitigation / Jinjiang Li, Mary E. Krause, Raymond Tu, editors.
ISBN 9783030571771 (electronic bk.)
3030571777 (electronic bk.)
9783030571764
3030571769
DOI https://doi.org/10.1007/978-3-030-57177-1
Published Cham : Springer : AAPS, [2021]
Language English
Description 1 online resource (340 pages)
Other Standard Identifiers 10.1007/978-3-030-57177-1 doi
Call Number RM301.25
Dewey Decimal Classification 615.1/9
Summary Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.
Note Includes index.
Access Note Access limited to authorized users.
Digital File Characteristics text file
PDF
Source of Description Description based on print version record.
Added Author Li, Jinjiang, author.
Krause, Mary E., author.
Tu, Raymond, author.
Series AAPS advances in the pharmaceutical sciences series ; v. 43.
Available in Other Form Protein Instability at Interfaces During Drug Product Development.
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Record Appears in Online Resources > Ebooks
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1. Overview of the impact of protein interfacial instability on the development of biologic products
2. Protein adsorption at a gas-aqueous interface
3. Interfacial behaviors of proteins
4. Interfacial stresses during drug substance purification processes
5. Evaluation of interfacial stress during drug product development
6. Relating interfacial shear and dilatations stress-es to protein aggregation in mAbs
7. Analytical techniques for evaluating protein instability at interfaces
8. Analysis of aggregates and particles
9. Protein interfacial instability of mixing and lyophilization during drug product manufacturing process scale-up and tech transfer
10. Excipients: Characterization, purpose, and selection
11. Interfacial stress and proteins prepared in the solid state
12. Interfaces in protein drug delivery: device concern
13. Future perspectives.

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