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Biopharmaceutical Production Technology, 2 Volume Set

ISBN: 978-3-527-33029-4
944 pages
August 2012
Biopharmaceutical Production Technology, 2 Volume Set (3527330291) cover image
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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Dr. Ganapathy Subramanian is a biotechnology consultant with over 30 years experience in industry and academia, encompassing the application and development of processing, purification methodologies, and chromatographic systems for largescale use in environmental science, food science, perfumery, cosmetics, and pharmaceuticals. He has also taught extensively in the area of food and medical technology.

A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate, from the University of Glasgow, for work on natural products. His main research interests lie in the utilization of natural material separation processes and bioconversions.

Dr. Subramanian has written and edited a number of books and articles in the field of biotechnology. For the last 10 years, he has been organizing conferences promoting the integration and sharing of knowledge between academia and industry.
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