タンパク療法のデリバリー技術

Abstract

Some of biotech' s most celebrated successes include:

• clotting factors
• anticoagulants
• modern insulins
• growth hormone
• follicle-stimulating hormone
• hematopoietic growth factors
• interferons
• interleukins

What do they have in common? They are therapeutic proteins, a market segment that had $34 billion in sales in 2004 and will have a projected $52.2 billion in sales in 2010*. As patents on first-generation proteins wind down, their owners naturally seek to protect their markets against interlopers. And in current and future battles for market share, protein delivery technologies are major weapons of offense and defense. It is a safe bet that if a therapeutic protein is bringing in big money and its patent is nearing expiration, someone somewhere with a clever technology is planning a market invasion based on improving how the protein is delivered. Delivery Technologies for Therapeutic Proteins: Assessment and Outlook analyzes and assesses protein delivery technologies developed by companies that are targeting:

• improved insulin delivery
• improved erythropoietin delivery
• improved interferon delivery
• improved growth hormone delivery

The report also analyzes and assesses noninjection delivery technologies, including technologies for:

• transdermal protein delivery
• oral protein delivery
• pulmonary protein delivery
• nasal protein delivery

Delivery Technologies for Therapeutic Proteins: Assessment and Outlook provides a thorough analysis and assessment of technologies for protein half-life extension and technologies for delivery of protein therapeutics.

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