Biopharmaceutical Production Technology: 2 Volume Set

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.

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

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.