High-Throughput Formulation Development of Biopharmaceuticals

High-Throughput Formulation Development of Biopharmaceuticals

Practical Guide to Methods and Applications

1st Edition - September 15, 2015

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  • Authors: Vladimir I. Razinkov, Gerd Kleemann
  • Hardcover ISBN: 9781907568633
  • eBook ISBN: 9781908818768

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Description

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.

Key Features

  • 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

Readership

All those biopharmaceutical specialists and scholars with interests around accelerated formulation development, high throughput methodologies, statistical analysis and related technologies

Table of Contents

    • 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

Product details

  • No. of pages: 132
  • Language: English
  • Copyright: © Woodhead Publishing 2016
  • Published: September 15, 2015
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9781907568633
  • eBook ISBN: 9781908818768

About the Authors

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

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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