Therapeutic Proteins Methods and Protocols 1st Edition by Mark Smales, David James ISBN 978-1592599226 1592599226

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Product details: 

ISBN 10: 1592599226

ISBN 13:  978-1592599226

Author: C. Mark Smales, David C. James 

With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Table of contents: 

Therapeutic Proteins: Methods and Protocols

1. Biopharmaceutical Proteins
   John R. Birch, Yemi Onakunle

2. Expression of Antibody Fragments by Periplasmic Secretion in Escherichia coli
   Andrew G. Popplewell, Mukesh Sehdev, Mariangela Spitali, A. Neil C. Weir

3. Secretory Production of Therapeutic Proteins in Escherichia coli
   Sang Yup Lee, Jong Hyun Choi, Sang Jun Lee

4. Expression of Recombinant LTB Protein in Marine Vibrio VSP60
   Wang Yili, Si Lusheng

5. Heterologous Gene Expression in Yeast
   Lee J. Byrne, Kenneth J. O’Callaghan, Mick F. Tuite

6. Pharmaceutical Proteins from Methylotrophic Yeasts
   Eric C. de Bruin, Erwin H. Duitman, Arjo L. de Boer, Marten Veenhuis, Ineke G. A. Bos, C. Erik Hack

7. Expression of Human Papillomavirus Type 16 L1 in Baculovirus Expression Systems
   Zheng Jin, Si Lusheng, Wang Yili

8. Large-Scale Transient Expression of Therapeutic Proteins in Mammalian Cells
   Sabine Geisse, Martin Jordan, Florian M. Wurm

9. Site-Specific Integration for High-Level Protein Production in Mammalian Cells
   Bhaskar Thyagarajan, Michele P. Calos

10. Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture
    Lily Chu, Ilse Blumentals, Gargi Maheshwari

11. Transgene Control Engineering in Mammalian Cells
    Beat P. Kramer, Martin Fussenegger

12. Fusion to Albumin as a Means to Slow the Clearance of Small Therapeutic Proteins Using the Pichia pastoris Expression System
    William P. Sheffield, Teresa R. McCurdy, Varsha Bhakta

13. High-Throughput Recovery of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli
    Amulya K. Panda

14. Isolation, Solubilization, Refolding, and Chromatographic Purification of Human Growth Hormone from Inclusion Bodies of Escherichia coli Cells
    Surinder M. Singh, A. N. S. Eshwari, Lalit C. Garg, Amulya K. Panda

15. Large-Scale Preparation of Factor VIIa from Human Plasma
    Teruhisa Nakashima, Kazuhiko Tomokiyo

16. Purification of Clinical-Grade Monoclonal Antibodies by Chromatographic Methods
    Alberto L. Horenstein, Ilaria Durelli, Fabio Malavasi

17. Virus Elimination and Validation
    Nicola Boschetti, Anna Johnston

18. Virus Removal by Nanofiltration
    Marina Korneyeva, Scott Rosenthal

19. Determining Residual Host Cell Antigen Levels in Purified Recombinant Proteins by Slot Blot and Scanning Laser Densitometry

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