Therapeutic proteins : methods and protocols

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Title:

Series:

Methods in molecular biology ; 308

Publication Information:

Totowa, NJ : Humana Press, 2005

ISBN:

9781588293909

Subject Term:

Protein drugs -- Laboratory manuals

Added Author:

Smales, C. Mark

James, David C. (David Cameron), 1963-

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010102082	RS431.P75 T43 2005	Open Access Book	Book	Searching... Unknown

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.

John R. Birch and Yemi OnakunleAndrew G. Popplewell and Mukesh Sehdev and Mariangela Spitali and A. Neil C. WeirSang Yup Lee and Jong Hyun Choi and Sang Jun LeeWang Yili and Si LushengLee J. Byrne and Kenneth J. O'Callaghan and Mick F. TuiteEric C. de Bruin and Erwin H. Duitman and Arjo L. de Boer and Marten Veenhuis and Ineke G. A. Bos and C. Erik HackZheng Jin and Si Lusheng and Wang YiliSabine Geisse and Martin Jordan and Florian M. WurmBhaskar Thyagarajan and Michele P. CalosLily Chu and Ilse Blumentals and Gargi MaheshwariBeat P. Kramer and Martin FusseneggerWilliam P. Sheffield and Teresa R. McCurdy and Varsha BhaktaAmulya K. PandaSurinder M. Singh and A. N. S. Eshwari and Lalit C. Garg and Amulya K. PandaTeruhisa Nakashima and Kazuhiko TomokiyoAlberto L. Horenstein and Ilaria Durelli and Fabio MalavasiNicola Boschetti and Anna JohnstonMarina Korneyeva and Scott RosenthalLaser Densitometry and Aaron P. Miles and Daming Zhu and Allan SaulScott P. Sellers and Yuh-Fun MaaYuh-Fun Maa and Scott P. SellersKen-ichi IzutsuAaron P. Miles and Allan SaulBernardo Perez-Ramirez and John J. SteckertLei Xie and Constance Cullen and Sheri Bradshaw and Marc DeLorenzo and Michael J. GraceDavid C. Wylie and Marcio Voloch and Seoju Lee and Yan-Hui Liu and Collette Cutler and Brittany Larkin and Susan Cannon-CarlsonAaron P. Miles and Allan SaulKenneth J. O'Callaghan and Lee J. Byrne and Mick F. TuiteC. Mark Smales and Rosalyn J. Marchant and Michèle F. UnderhillRodney G. Keck and John B. Briggs and Andrew J. S. JonesStacey Ma and Wendy Lau and Rodney G. Keck and John B. Briggs and Andrew J. S. Jones and Kathy Moorhouse and Wassim NashabehLihua Huang and Charles E. MitchellLihua Huang and Charles E. Mitchell and Lei Yu and P. Clayton Gough and Alice RigginJason C. Rouse and Joseph E. McClellan and Himakshi K. Patel and Michael A. Jankowski and Thomas J. PorterMark J. Howard

Preface	p. v
Contributors	p. xi
1 Biopharmaceutical Proteins: Opportunities and Challenges	p. 1
2 Expression of Antibody Fragments by Periplasmic Secretion in Escherichia coli	p. 17
3 Secretory Production of Therapeutic Proteins in Escherichia coli	p. 31
4 Expression of Recombinant LTB Protein in Marine Vibrio VSP60	p. 43
5 Heterologous Gene Expression in Yeast	p. 51
6 Pharmaceutical Proteins from Methylotrophic Yeasts	p. 65
7 Expression of Human Papillomavirus Type 16 L1 in Baculovirus Expression Systems: A Case Study	p. 77
8 Large-Scale Transient Expression of Therapeutic Proteins in Mammalian Cells	p. 87
9 Site-Specific Integration for High-Level Protein Production in Mammalian Cells	p. 99
10 Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture	p. 107
11 Transgene Control Engineering in Mammalian Cells	p. 123
12 Fusion to Albumin as a Means to Slow the Clearance of Small Therapeutic Proteins Using the Pichia pastoris Expression System: A Case Study	p. 145
13 High Throughput Recovery of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli: An Overview	p. 155
14 Isolation, Solubilization, Refolding, and Chromatographic Purification of Recombinant Human Growth Hormone from Inclusion Bodies of Escherichia coli cells: A Case Study	p. 163
15 Large-Scale Preparation of Factor VIIa from Human Plasma: A Case Study	p. 177
16 Purification of Clinical-Grade Monoclonal Antibodies by Chromatographic Methods	p. 191
17 Virus Elimination and Validation	p. 209
18 Virus Removal by Nanofiltration	p. 221
19 Determining Residual Host Cell Antigen Levels in Purified Recombinant Proteins by Slot Blot and Scanning	p. 233
20 Principles of Biopharmaceutical Protein Formulation: An Overview	p. 243
21 Solid-State Protein Formulation: Methodologies, Stability, and Excipient Effects	p. 265
22 Stabilization of Therapeutic Proteins by Chemical and Physical Methods	p. 287
23 Extraction and Characterization of Vaccine Antigens from Water-In-Oil Adjuvant Formulations	p. 293
24 Probing Reversible Self-Association of Therapeutic Proteins by Sedimentation Velocity in the Analytical Ultracentrifuge	p. 301
25 Biological Characterization of Pegylated Interferons: A Case Study	p. 319
26 Characterization of Interferon a2B Pegylated Via Carboxyalkylation: A Case Study	p. 337
27 Quantifying Recombinant Proteins and Their Degradation Products Using SDS-PAGE and Scanning Laser Densitometry	p. 349
28 Extraction and Denaturing Gel Electrophoretic Methodology for the Analysis of Yeast Proteins	p. 357
29 Characterization of Therapeutic Proteins by Membrane and In-Gel Tryptic Digestion	p. 375
30 Oligosaccharide Release and MALDI-TOF MS Analysis of N-Linked Carbohydrate Structures from Glycoproteins	p. 381
31 Capillary Electrophoresis of Carbohydrates Derivatized with Fluorophoric Compounds	p. 397
32 High-Throughput LC/MS Methodology for ¿(1→3)Gal Determination of Recombinant Monoclonal Antibodies: A Case Study	p. 411
33 Carbohydrate Structural Characterization of Fas Ligand Inhibitory Protein	p. 421
34 Top-Down Characterization of Protein Pharmaceuticals by Liquid Chromatography/Mass Spectrometry: Application to Recombinant Factor IX Comparability-A Case Study	p. 435
35 Sample Preparation Procedures for High-Resolution Nuclear Magnetic Resonance Studies of Aqueous and Stabilized Solutions of Therapeutic Peptides	p. 461
Index	p. 471

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