Biopharmaceutical Production Technology. 2 Volume Set

  • ID: 2183386
  • Book
  • 944 Pages
  • John Wiley and Sons Ltd
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Cost–effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes.

This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals.

It is divided into seven major parts:

– Upstream Technologies

– Protein Recovery

– Advances in Process Development

– Analytical Technologies

– Quality Control

– Process Design and Management

– Changing Face of Processing

With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first–hand knowledge on how to produce biopharmaceuticals in a cost–effective and quality–controlled manner.
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UPSTREAM TECHNOLOGIES

Strategies for Plasmid DNA Production in Escherichia coli

Advances in Protein Production Technologies

PROTEIN RECOVERY

Releasing Biopharmaceutical Products from Cells

Continuous Chromatography (Multicolumn Countercurrent Solvent Gradient Purification) for Protein Purification

Virus–Like Particle Bioprocessing

Therapeutic Protein Stability and Formulation

Production of PEGylated Proteins

ADVANCES IN PROCESS DEVELOPMENT

Affinity Chromatography: Historical and Prospective Overview

Hydroxyapatite in Bioprocessing

Monoliths in Bioprocessing

Membrane Chromatography for Biopharmaceutical Manufacturing

Modeling and Experimental Model Parameter Determination with Quality by Design for Bioprocesses

ANALYTICAL TECHNOLOGIES

Biosensors in the Processing and Analysis of Biopharmaceuticals

Proteomics Toolkit: Applications in Protein Biological Production and Method Development

Science of Proteomics: Historical Perspectives and Possible Role in Human Healthcare

QUALITY CONTROL

Consistency of Scale–Up from Bioprocess Development to Production

Systematic Approach to Optimization and Comparability of Biopharmaceutical Glycosylation Throughout the Drug Life Cycle

Quality and Risk Management in Ensuring the Virus Safety of Biopharmaceuticals

Ensuring Quality and Efficiency of Bioprocesses by the Tailored Application of Process Analytical Technology and Quality by Design

PROCESS DESIGN AND MANAGEMENT

Bioprocess Design and Production Technology for the Future

Integrated Process Design: Characterization of Process and Product Definition of Design Spaces

Evaluating and Visualizing the Cost–Effectiveness and Robustness of Biopharmaceutical Manufacturing Strategies

CHANGING FACE OF PROCESSING

Full Plastics: Consequent Evolution in Pharmaceutical Biomanufacturing from Vial to Warehouse

BioSMB Technology: Continuous Countercurrent Chromatography Enabling a Fully Disposable Process

Single–Use Technology: Opportunities in Biopharmaceutical Processes

Single–Use Biotechnologies and Modular Manufacturing Environments Invite Paradigm Shifts in Bioprocess Development and Biopharmaceutical Manufacturing

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Ganapathy Subramanian
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