Therapeutic Proteins : methods and protocols /edited by C. Mark Smales and David C. James. --Humana Press, 2005. -- (58.17/M592/v.308)

Contents

Contents:

1.Biopharmaceutical Proteins: Opportunities and Challenges  1

2.Expression of Antibody Fragments by Periplasmic Secretion  17

3.Secretory Production of Therapeutic Proteins in Escherichia coli  31

4.Expression of Recombinant LTB Protein in Marine Vibrio VSP60  43

5.Heterologous Gene Expression in Yeast  51

6.Pharmaceutical Proteins from Methylotrophic Yeasts  65

7.Expression of Human Papillomavirus Type 16 L1 in Baculovirus Expression Systems: A Case Study  77

8. Large-Scale Transient Expression of Therapeutic Proteins In Mammalian Cells  87

9.Site-Specific Integration for High-Level Protein Production in Mammalian Cells  99

10.Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture  107

11.Transgene Control Engineering in Mammalian Cells  123

12. Fusion to Albumin as a Means to slow the Clearance of Small Therapeutic Proteins Using the Pichia pastoris Expression System: A

     Case Studty  145

13.High Throughput Recovery of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli: An Overview  155

14.Isolation, Solubilization, Refolding, and Chromatographic Purification of Recombinant Human Growth Hormone from 

    Inclusion Bodies of Escherichia coli cells: A Case Study  163

15.Large-Scale Preparation of Factor VIIa from Human Plasma: A Case Study  177

16.Purification of Clinical-Grade Monoclonal Antibodies by Chromatographic Methods  191

17.Virus Elimination and Validation  209

18.Virus Removal by Nanofiltration  221

19.Determining Residual Host Cell Antigen Levels in Purified Recombinat Proteins by

     Slot Blot and Scanning Laser Densitometry  223

20.Principles of Biopharmaceutical Protein Formulation: An Overview  243

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