Therapeutic Proteins

1. Principles of Biopharmaceutical Protein Formulation

   • Scott P. Sellers, Yuh-Fun Maa

   Pages 243-263

2. Solid-State Protein Formulation

   • Yuh-Fun Maa, Scott P. Sellers

   Pages 265-285

3. Stabilization of Therapeutic Proteins by Chemical and Physical Methods

   • Ken-ichi Izutsu

   Pages 287-292

4. Extraction and Characterization of Vaccine Antigens from Water-in-Oil Adjuvant Formulations

   • Aaron P. Miles, Allan Saul

   Pages 293-300

5. Probing Reversible Self-Association of Therapeutic Proteins by Sedimentation Velocity in the Analytical Ultracentrifuge

   • Bernardo Perez-Ramirez, John J. Steckert

   Pages 301-318

6. Biological Characterization of Pegylated Interferons

   • Lei Xie, Constance Cullen, Sheri Bradshaw, Marc DeLorenzo, Michael J. Grace

   Pages 319-335

7. Characterization of Interferon α2B Pegylated via Carboxyalkylation

   • David C. Wylie, Marcio Voloch, Seoju Lee, Yan-Hui Liu, Collette Cutler, Brittany Larkin et al.

   Pages 337-348

8. Quantifying Recombinant Proteins and Their Degradation Products Using SDS-PAGE and Scanning Laser Densitometry

   • Aaron P. Miles, Allan Saul

   Pages 349-356

9. Extraction and Denaturing Gel Electrophoretic Methodology for the Analysis of Yeast Proteins

   • Kenneth J. O’Callaghan, Lee J. Byrne, Mick F. Tuite

   Pages 357-373

10. Characterization of Therapeutic Proteins by Membrane and In-Gel Tryptic Digestion

    • C. Mark Smales, Rosalyn J. Marchant, Michèle F. Underhill

    Pages 375-379

11. Oligosaccharide Release and MALDI-TOF MS Analysis of N-Linked Carbohydrate Structures from Glycoproteins

    • Rodney G. Keck, John B. Briggs, Andrew J. S. Jones

    Pages 381-396

12. Capillary Electrophoresis of Carbohydrates Derivatized With Fluorophoric Compounds

    • Stacey Ma, Wendy Lau, Rodney G. Keck, John B. Briggs, Andrew J. S. Jones, Kathy Moorhouse et al.

    Pages 397-409

13. High-Throughput LC/MS Methodology for α(1→3)Gal Determination of Recombinant Monoclonal Antibodies

    • Lihua Huang, Charles E. Mitchell

    Pages 411-419

14. Carbohydrate Structural Characterization of Fas Ligand Inhibitory Protein

    • Lihua Huang, Charles E. Mitchell, Lei Yu, P. Clayton Gough, Alice Riggin

    Pages 421-434

15. Top-Down Characterization of Protein Pharmaceuticals by Liquid Chromatography/Mass Spectrometry

    • Jason C. Rouse, Joseph E. McClellan, Himakshi K. Patel, Michael A. Jankowski, Thomas J. Porter

    Pages 435-460

16. Sample Preparation Procedures for High-Resolution Nuclear Magnetic Resonance Studies of Aqueous and Stabilized Solutions of Therapeutic Peptides

    • Mark J. Howard

    Pages 461-469

17. Back Matter

    Pages 471-482

    PDF

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.

• Antigen
• Filtration
• gene expression
• interferon
• proteins

"...scientists in the area will find the material of value." - Doody's Health Sciences Book Review Journal

• Protein Science Group, Department of Biosciences, University of Kent, Canterbury, UK

  C. Mark Smales

• School of Engineering, University of Queensland, St. Lucia, Australia

  David C. James

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