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📙 Biopharmaceutical Production Technology, Volume 1 & Volume 2 by — free download


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.Content:
Chapter 1 Strategies for Plasmid DNA Production in Escherichia coli (pages 1–41): Eva Brand, Kathrin Ralla and Peter Neubauer
Chapter 2 Advances in Protein Production Technologies (pages 43–77): Linda H. L. Lua and Yap Pang Chuan
Chapter 3 Releasing Biopharmaceutical Products from Cells (pages 79–105): Anton P. J. Middelberg
Chapter 4 Continuous Chromatography (Multicolumn Countercurrent Solvent Gradient Purification) for Protein Purification (pages 107–137): Guido Strohlein, Thomas Muller?Spath and Lars Aumann
Chapter 5 Virus?Like Particle Bioprocessing (pages 139–163): Yap Pang Chuan, Linda H. L. Lua and Anton P. J. Middelberg
Chapter 6 Therapeutic Protein Stability and Formulation (pages 165–198): Robert Falconar
Chapter 7 Production of PEGylated Proteins (pages 199–222): Conan J. Fee and Vinod B. Damodaran
Chapter 8 Affinity Chromatography: Historical and Prospective Overview (pages 223–282): Laura Rowe, Graziella El Khoury and Christopher R. Lowe
Chapter 9 Hydroxyapatite in Bioprocessing (pages 283–331): Frank Hilbrig and Ruth Freitag
Chapter 10 Monoliths in Bioprocessing (pages 333–375): Ales Podgornik, Milos Barut, Matjaz Peterka and Ales Strancar
Chapter 11 Membrane Chromatography for Biopharmaceutical Manufacturing (pages 377–408): Omar M. Wahab
Chapter 12 Modeling and Experimental Model Parameter Determination with Quality by Design for Bioprocesses (pages 409–443): Christoph Helling and Jochen Strube
Chapter 13 Biosensors in the Processing and Analysis of Biopharmaceuticals (pages 445–471): Sriram Kumaraswamy
Chapter 14 Proteomics Toolkit: Applications in Protein Biological Production and Method Development (pages 473–487): Glenwyn Kemp and Achim Treumann
Chapter 15 Science of Proteomics: Historical Perspectives and Possible Role in Human Healthcare (pages 489–509): Nawin Mishra
Chapter 16 Consistency of Scale?Up from Bioprocess Development to Production (pages 511–543): Stefan Junne, Arne Klingner, Dirk Itzeck, Eva Brand and Peter Neubauer
Chapter 17 Systematic Approach to Optimization and Comparability of Biopharmaceutical Glycosylation Throughout the Drug Life Cycle (pages 545–583): Daryl L. Fernandes
Chapter 18 Quality and Risk Management in Ensuring the Virus Safety of Biopharmaceuticals (pages 585–612): Andy Bailey
Chapter 19 Ensuring Quality and Efficiency of Bioprocesses by the Tailored Application of Process Analytical Technology and Quality by Design (pages 613–656): Helmut Trautmann
Chapter 20 Bioprocess Design and Production Technology for the Future (pages 657–705): Jochen Strube, Florian Grote and Reinhard Ditz
Chapter 21 Integrated Process Design: Characterization of Process and Product Definition of Design Spaces (pages 707–715): Richard Francis
Chapter 22 Evaluating and Visualizing the Cost?Effectiveness and Robustness of Biopharmaceutical Manufacturing Strategies (pages 717–741): Suzanne S. Farid
Chapter 23 Full Plastics: Consequent Evolution in Pharmaceutical Biomanufacturing from Vial to Warehouse (pages 743–767): Roland Wagner and Dethardt Muller
Chapter 24 BioSMB™ Technology: Continuous Countercurrent Chromatography Enabling a Fully Disposable Process (pages 769–791): Marc Bisschops
Chapter 25 Single?Use Technology: Opportunities in Biopharmaceutical Processes (pages 793–816): Maik W. Jornitz, Detlev Szarafinski and Thorsten Peuker
Chapter 26 Single?Use Biotechnologies and Modular Manufacturing Environments Invite Paradigm Shifts in Bioprocess Development and Biopharmaceutical Manufacturing (pages 817–857): Alfred Luitjens, John Lewis and Alain Pralong

About book:

  • Author:
  • Year: 2012
  • Language: English
  • ISBN: 9783527330294,9783527653096

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  • File size: 11 111 675
  • Format: pdf


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