Delivery Technologies for Protein Therapeutics: Assessment and Outlook

Table of Contents

EXECUTIVE SUMMARY

Chapter 1 INTRODUCTION: TRENDS IN TECHNOLOGY FOR DELIVERING PROTEIN THERAPEUTICS

• 1.1. Why Better Delivery For Therapeutic Proteins Is Needed
  • Alternatives to Injection
• 1.2. Organization of this Report
• 1.3. Protein Engineering Technologies
• 1.4. Non-Injection Technologies
• 1.5. Insulin: El Dorado of Protein Delivery Tech
  • Multiple Products, Multiple Mechanisms
• 1.6. Business and Market Outlook
  • Competition Among Noninjection Technologies
• 1.7. When Will Tech Trends Merge?

Chapter 2 ENGINEERING THERAPEUTIC PROTEINS FOR LONGER HALF-LIFE

• 2.1. Introduction
  • PEGylated Interferons
• 2.2. Increasing Half-life by PEGylation
  • Releasable PEGylation
• 2.3. Increasing Half-life by Site-specific PEGylation
  • ReCODE Technology
• 2.4. Increasing Half-life by Conjugation with Polysialic Acid
  • PolyXen Technology
• 2.5. Increasing Half-life by Albumin Gene Fusion
• 2.6. Increasing Half-life by Albumin Conjugation
  • DAC and PC-DAC Technologies
• 2.7. Increasing Half-life by Albumin-binding Fatty Acids
• 2.8. Increasing Half-life by Albumin-binding Peptides
• 2.9. Increasing Half-life with the Streptococcal Albumin-binding Domain
• 2.10. Increasing Half-life by Transferrin Gene Fusion
• 2.11. Increasing Half-life by Hyperglycosylation
• 2.12. Increasing Half-life by Glycosylation Completion and GlycoPEGylation
• 2.13. Increasing Half-life by Humanized Glycosylation
• 2.14. Increasing Half-life by Protease-resistant Point Mutations

Chapter 3 OTHER PROTEIN ENGINEERING TECHNOLOGIES TO IMPROVE PROTEIN DELIVERY

• 3.1. Reducing Immunogenicity through Bioinformatics
  • Epibase Software
• 3.2. Reducing Protein Aggregation through Bioinformatics
  • AggreSolve Algorithms
• 3.3. Refolding Protein Aggregates through High Pressure Technology
  • PreEMT Technology

Chapter 4 TECHNOLOGIES FOR TRANSDERMAL DELIVERY OF PROTEINS

• 4.1. Introduction
• 4.2. Delivery by Radio Frequency (RF) Microelectrode Array
• 4.3. Active Delivery by Ultrasound
  • U-Strip Ultrasound Module
• 4.4. Passive Delivery by Ultrasound
  • SonoPrep Device
• 4.5. Delivery by Thermal Burst
  • PassPort System
• 4.6. Delivery by Iontophoresis
  • Actyve Patches
• 4.7. Delivery by Transfersomes

Chapter 5 Technologies for Oral Delivery of Proteins

• 5.1. Introduction
• 5.2. Oral Protein Delivery using Carrier Molecules
  • Eligen Technology
• 5.3. Oral Protein Delivery using Crystallization Technology
  • Crystalomics
• 5.4. Oral Protein Delivery by Calcium Phosphate Nanoparticles
  • BioOral System
• 5.5. Oral Protein Delivery by Buccal Mouth Spray
  • RapidMist and Oral-lyn
• 5.6. Oral Protein Delivery using Amphiphilic Oligomers
  • HIM2 to IN-105

Chapter 6 TECHNOLOGIES FOR PULMONARY AND NASAL DELIVERY OF PROTEINS

• 6.1. Pulmonary Delivery using Dry Powder Inhalers
  • Milestone: Exubera
• 6.2. Other Protein Inhaler Technologies
  • Competing Products in Clinical Trials
• 6.3. Pulmonary Delivery using Antibody Transcytosis Fusion Proteins
  • FcRn Pathway
• 6.4. Nasal Delivery using Mucosal Absorption Enhancers, Part 1
  • IntraVail Technology
  • Pro Tek Excipients
• 6.5. Nasal Delivery using Mucosal Absorption Enhancers, Part 2
• 6.6. Nasal Delivery via Tight Junction Modulation

Chapter 7 EXPERT INTERVIEWS

• 7.1. Abe S. Abuchowski, PhD, CEO, Prolong Pharmaceuticals
• 7.2. Ajay K. Banga, PhD, Professor and Chair, Department of Pharmaceutical Sciences, Mercer University
• 7.3. Eric Tomlinson, DSc, PhD, President and CEO, Altea Therapeutics
• 7.4. Manuel Vega, PhD, CEO Nautilus Biotech

APPENDIX: CHI ADVANCES REPORTS - PROTEIN DRUG DELIVERY SURVEY - DECEMBER 2006

COMPANY INDEX WITH WEB ADDRESSES

REFERENCES