High-Throughput Formulation Development of Biopharmaceuticals
Practical Guide to Methods and Applications
- 1st Edition - September 29, 2016
- Latest edition
- Authors: Vladimir I. Razinkov, Gerd Kleemann
- Language: English
- Hardback ISBN:9 7 8 - 1 - 9 0 7 5 6 8 - 6 3 - 3
- eBook ISBN: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
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
- Edition: 1
- Latest edition
- Published: September 29, 2016
- Language: English
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, USAGK
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, USARead High-Throughput Formulation Development of Biopharmaceuticals on ScienceDirect