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High-Throughput Formulation Development of Biopharmaceuticals
Practical Guide to Methods and Applications
1st Edition - September 28, 2016
Authors: Vladimir I. Razinkov, Gerd Kleemann
Language: English
Hardback ISBN:9781907568633
9 7 8 - 1 - 9 0 7 5 6 8 - 6 3 - 3
eBook ISBN:9781908818768
9 7 8 - 1 - 9 0 8 8 1 8 - 7 6 - 8
High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable…Read more
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High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development.
The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.
Presents applications of high-throughput methodologies to accelerate drug formulation development
Provides the latest technologies in the field
Includes key statistical approaches, such as design of experiment and multivariate data analysis
Written by highly respected formulation development experts
All those biopharmaceutical specialists and scholars with interests around accelerated formulation development, high throughput methodologies, statistical analysis and related technologies
About the authors
1. High-throughput methodology in biopharmaceutical formulation development
Abstract
References
2. Early candidate selection and formulation development
Abstract
2.1 Screening for colloidal and conformational stability
2.2 Screening for viscosity
2.3 Screening for chemical stability
2.4 Engineering or formulating protein stability
2.5 Formulation by design
References
3. Preclinical and clinical formulation studies
Abstract
3.1 High-throughput manufacturability assessment
3.2 Modality-specific formulation screening
3.3 How to predict long-term stability of formulations
References
4. Late-stage and commercial formulation development
Abstract
4.1 Development of a robust formulation design space
4.2 Application of automation and high-throughput technologies for formulation design space development
References
5. Analysis of high-throughput data
Abstract
5.1 Seeing is believing: the power of data visualization
5.2 Making sense of high-throughput screening and multidimensional characterization
5.3 Closing words
References
Index
No. of pages: 132
Language: English
Edition: 1
Published: September 28, 2016
Imprint: Woodhead Publishing
Hardback ISBN: 9781907568633
eBook ISBN: 9781908818768
VR
Vladimir I. Razinkov
Vladimir Razinkov is a principal scientist in the Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
Affiliations and expertise
Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
GK
Gerd Kleemann
Gerd R. Kleemann is a scientific director in the Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
Affiliations and expertise
Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
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