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Delivery Technologies for Protein Therapeutics: Assessment and Outlook

CHI Insight Pharma Reports
March 1, 2007
164 Pages - SKU: CHI1646627

Abstract Table of Contents Related Reports

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

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 INSIGHT REPORTS - PROTEIN DRUG DELIVERY SURVEY - DECEMBER 2006
COMPANY INDEX WITH WEB ADDRESSES
REFERENCES
Tables: Table 1.1. Companies Targeting Improved Insulin Delivery; Table 1.2. Companies Targeting Improved Erythropoietin Delivery; Table 1.3. Companies Targeting Improved Growth Hormone Delivery; Table 1.4. Companies Targeting Improved Interferon Delivery; Table 1.5. Companies Targeting Improved Parathyroid Hormone Delivery; Table 2.1. Technologies for Extending Therapeutic Protein Half-life; Table 2.2. FDA-Approved Therapeutic Proteins Engineered for Extended Half-life
Figures: Figure 2.1. Multiple Benefits of Extending Half-life; Figure 2.2. PEG Mechanisms for Drug Delivery; Figure 2.3. SWOT Analysis for Releasable Pegylation; Figure 2.4. ReCODE: Biosynthetic Incorporation of Chemically Specified Amino Acids; Figure 2.5. SWOT Analysis for Site-specific Pegylation; Figure 2.6. Polysialic Acid Protects Against Proteases; Figure 2.7. Extending Therapeutic Protein Half-Life with Human Serum Albumin Fusion Technology; Figure 2.8. SWOT Analysis for Albumin Gene Fusion; Figure 2.9. SWOT Analysis for Albumin Conjugation; Figure 2.10. Structure of Insulin Detemir; Figure 2.11. SWOT Analysis for Albumin-binding peptides; Figure 2.12. Tertiary Structure of an Affibody Molecule; Figure 2.13. Peptide Fused via a Peptide Linker to the N Terminus of Transferrin; Figure 2.14. SWOT Analysis for Hyperglycosylation; Figure 2.15. Glycolylation Pattern Depends on Expression System; Figure 2.16. Enzymes Add Missing Sugars; Figure 2.17. PEGylation of a Protein on a Carbohydrate Chain; Figure 2.18. SWOT Analysis for Glycopegylation; Figure 2.19. SWOT Analysis for Humanized Glycosylation in Yeast; Figure 2.20. SWOT Analysis for Pretease-Resistant Point Mutations; Figure 3.1. Typical Effects of PreEMT System Pressure on Protein Aggregates; Figure 4.1. Micro Processor; Figure 4.2. Delivery of Insulin in Humans; Figure 4.3. SWOT Analysis for Transdermal Delivery of Proteins via RF-Microchannels; Figure 4.4. SWOT Analysis for Active Delivery by Ultrasound; Figure 4.5. SWOT Analysis for Passive Delivery by Ultrasound; Figure 4.6. Transdermal Delivery by Charge Repulsion; Figure 4.7. Dosage Patterns for Actyve; Figure 4.8. SWOT Analysis for Delivery by Iontophoresis; Figure 4.9. SWOT Anslysis for Delivery by Transferomes; Figure 5.1. Oral Delivery by Carrier Molecules; Figure 5.2. SWOT Analysis for Oral Protein Delivery Using Carrier Molecules; Figure 5.3a. Toxic Metabolites in the Blood Before Therapy; Figure 5.3b. Metabolite Gradient Set in Motion by Protein Crystals; Figure 5.4. SWOT Analysis for Oral Protein Delivery by Protein Crystalization; Figure 5.5. Calcium-PEG-Insulin-Casein; Figure 5.6. SWOT Analysis for RapidMist Buccal Protein Delivery; Figure 5.7. SWOT Analysis for Protein Delivery with Amphiphilic Oligomers; Figure 6.1. SWOT Analysis of Pulmonary Protein Delivery Using Dry Powder Inhalers; Figure 6.2. Epithelial Pinocytosis of Fc Therapeutic Fusion Proteins; Figure 6.3. Structures of Syntonix Therapeutic Fusion Proteins; Figure 6.4. SWOT Analysis of Pulmonary Protein Delivery Using Antibody Transcytosis Fusion Proteins; Figure 6.5. SWOT Analysis of Intranasal Protein Delivery Using Aegis Therapeutics’ Mucosal Absorption Enhancers; Figure 6.6. SWOT Analysis of Intranasal Protein Delivery Using Bentley Pharmaceuticals’ Mucosal Absorption Enhancers; Figure 6.7. Junctions Between Epithelial Cells
Appendix Figures: CHI Insight Pharma Reports - Protein Drug Delivery Survey - December 2006: Figure 1A. Respondents by Sector; Figure 2A. Focus of Respondents; Figure 3A. Delivery Technologies and New Indications for Drugs; Figure 4A. Technologies and Competitiveness; Figure 5A. PEGylation Dominance in the Marketplace; Figure 6A. Trend in Increasing Half-Life of Therapeutic Proteins; Figure 7A. Competitors’ Use of Longer Half-Life Proteins; Figure 8A. Alternatives to Injection; Figure 9A. Competitors and Injection; Figure 10A. Noninjection and Patient Compliance; Figure 11A. Improved Technologies and Prices of Treatments; Figure 12A. Involvement with Approved Therapies; Figure 13A. Oral Protein Delivery vs. Transdermal; Figure 14A. …. vs. Pulmonary; Figure 15A. …. Nasal; Figure 16A. Specialist vs. Primary Care; Figure 17A. Longer Half-Lives vs. Injection; Figure 18A. Noninjection Monoclonal Antibodies

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