Table of Contents
chapter one: Executive Summary
- Introduction
- Scope and Methodology
- Transgenesis Development
- Biopharmaceuticals Derived from Transgenic Sources
- The Expanding Biopharmaceuticals Market
- Manufacturing Biopharmaceuticals
- The Commercial Transgenic Rodent Business
- Transgenic Domestic Animals and Plants: An Alternative Biomanufacturing
Method
- Transgenic Expression Compared with Traditional Production Methods
- Transgenic Animals
- Protein Expression in Milk and Blood
- Avian Transgenics
- Animal-Derived Biopharmaceuticals in Research and Clinical Trials
- Product Candidates Generated in Transgenic Cattle
- Product Candidates Generated in Transgenic Goats
- Product Candidate Generated in Transgenic Rabbits
- Avian-Derived Products in Research and Development
- Transgenics Plants
- Capacity Comparison: Plants with Other Transgenic Systems
- Major Advantages of Plant-Derived Proteins
- Plant-Derived Biopharmaceuticals in Research and Clinical Trials
- Transgenic Arabidopsis
- Transgenic Corn
- Transgenic Lemna
- Transgenic Tobacco
- Projected Market for Transgenically Produced Biopharmaceuticals
chapter Two: The Development and Manufacture of Transgenically Produced
Biopharmaceuticals
- Molecular Biology and Genetic Engineering
- Biopharmaceuticals Derived from Transgenic Sources
- The Expanding Biopharmaceuticals Market
- Manufacturing Biopharmaceuticals
- Cell-Based Manufacturing Systems Are Costly and Inefficient
- Improving Volumetric Productivity
- Transgenic Domestic Animals and Plants: An Alternative Biomanufacturing
Method
- Domestic Animals as Bioreactors
- Proteins Produced in Transgenic Chickens
- Plants as Bioreactors for Biopharmaceutical Production
- Public Perceptions of Transgenic Animals and Plants
- Biotechnology-Focused Legislation
chapter Three: Transgenic Rodents Developed for Research and Biopharmaceutical
Production
- Producing Transgenic Mice
- Pronuclear Microinjection
- Knockout Gene Technology
- Knock-in Gene Technology
- Embryonic Stem Cell Techniques
- Somatic Nuclear Transfer
- Value of Transgenic Rodents
- Rodent Models of Human Disease
- Transgenic Models Characterized for Human Diseases
- Rodent Antibodies as Therapeutic Agents
- Types of Rodent-Derived Antibodies
- Murine Antibody
- Chimeric Antibody
- Humanized Antibody
- Fully Human Antibody
- Manufacturing Biopharmaceuticals
- Phage Display: A Competing Technology
- The Commercial Transgenic Rodent Business
- Commercial Sale of Transgenic Rodents
- Commercial Rodent Model Market
- Leading Companies Providing Commercial Rodent Models
- Commercial Rodent Model Market Trends
chapter four: Transgenically Produced Biopharmaceuticals in Animal and Avian
Platforms
- Introduction
- Applications of Transgenesis
- Transgenic Domestic Animals as Bioreactors
- Transgenic Domestic Animal as a Model for Disease
- Transgenic Mammals
- Transgenic Protein Expression Compared with Traditional Production Methods
- Protein Expression in Milk and Blood
- Key Characteristics of Transgenic Mammals
- General Management Practices for Specialized Farms
- Relevant Regulatory Agencies and Regulatory Authority
- Animal-Derived Biopharmaceuticals in Research and Clinical Trials
- Types of Transgenic Mammals and Their Product Candidates
- Transgenic Cattle
- Transgenic Goats
- Transgenic Rabbits
- Transgenic Sheep
- Transgenic Swine
- Avian Transgenics
- Potential for Reduced Capital Outlay
- Large Amount of Protein Generated Quickly
- Ease of Scale-up
- Glycosylation
- Contained and Controlled Environment
- Avian Transgenic Technology
- Anticancer Antibody Expressed in Chicken Eggs
- Monoclonal Antibodies Produced in Chickens
- Avian-Derived Products in Research and Development
chapter five: Transgenically Produced Biopharmaceuticals Manufactured in Plant
Platforms
- Introduction
- History of the Production rDna Proteins in Plants
- Transgenic Plant Technology
- Agrobacterium Tumefaciens-Mediated Transformation System
- Particle Bombardment Transformation System
- Future Developments in Transgenic Technology
- Transgenic Plants Come of Age
- The Benefits of Producing Biopharmaceuticals in Plants
- Potential Risks Associated with Producing Biopharmaceuticals in Plants
- Contamination of Non-Transgenic Crops Intended for Human Consumption
- The Containment Challenge
- Field Testing of PMPs in the U.S.
- Genetic Use Restriction Technologies
- Plant-Derived Biopharmaceuticals in Research and Clinical Trials
- Transgenic Arabidopsis
- Transgenic Corn
- Transgenic Lemna
- Transgenic Tobacco
chapter six: Projected Market for Transgenically Produced BioPharmaceuticals
Manufactured in Plant and Animal Platforms
- Introduction
- Biopharmaceutical Market Maturing Rapidly
- Transgenic Animal and Plant Factories: An Emerging Biotechnology Sector
- Transgenic Animal and Plant Bioreactors: An Alternative Production System
for Biopharmaceuticals
- Projected Market for Transgenically Produced Biopharmaceuticals
- Projected Sales of Transgenically Manufactured Products Closest to Market
- ATryn
- CaroRX
- rhC1NH
chapter Seven: Company Profiles
- Abgenix, Inc.
- History and Lines of Business
- Corporate Strategies
- Transgenic Products and Product Candidates
- Financial Information
- Avigenics, Inc
- History and Lines of Business
- Corporate Strategy
- Transgenic Technology and Product Candidates
- Financial Information
- Biolex Therapeutics, Inc.
- History and Lines of Business
- Corporate Strategies
- Transgenic Technology
- Financial Information
- Charles River Laboratories, Inc.
- History and Lines of Business
- Corporate Strategy
- Research Models and Services Business
- Financial Information
- GTC Biotherapeutics, Inc,.
- History and Lines of Business
- Transgenic Technology and Product Candidates
- Financial Information
- Hematech LLC
- History and Lines of Business
- Transgenic Technology
- Antibodic Resistant Infections
- Immune Deficiencies
- Other Applications
- Financial Information
- Large Scale Biology Corporation
- History and Lines of Business
- Corporate Strategies
- Transgenic Technology and Product Candidates
- Financial Information
- Medarex, Inc.
- History and Lines of Business
- Corporate Strategies
- Transgenic Technology and Product Candidates
- Financial Information
- Origen Therapeutics
- History and Lines of Business
- Transgenic Technology
- Financial Information
- Pharming Group NV
- History and Lines of Business
- Transgenic Technology and Product Candidates
- Financial Information
- Phytomedics, Inc.
- History and Lines of Business
- Corporate Strategy
- Transgenic Technology
- Financial Information
- Planet Biotechnology Inc.
- History and Lines of Business
- Transgenic Technology and Product Candidates
- Financial Information
- ProdiGene, Inc.
- History and Lines of Business
- Corporate Strategy
- Transgenic Technology and Product Candidates
- Financial Information
- SemBioSys Genetics, Inc.
- History and Lines of Business
- Transgenic Technology and Product Candidates
- Financial Information
- Taconic Farms, Inc.
- History and Lines of Business
- Research Models and Services Business
- Financial Information
- Ventria Bioscience
- History and Lines of Business
- Corporate Strategy
- Transgenic Technology and Product Candidates
- Financial Information
- Viragen International, Inc.
- History and Lines of Business
- Transgenic Technology
- Financial Information
- Xenogen Corporation
- History and Lines of Business
- Transgenic Technology and Products
- IVIS Imaging Systems and Living Image Software
- Bioware--Light-Producing Cells and Microorganisms
- LPTA Animal Models
- Financial Information
Appendix A: Company Directory
Appendix B: Biopharmaceuticals Produced in Transgenic Animal and Plant
Platforms in Research and Clinical Trials
List of Exhibits
chapter one: Executive Summary
- Table 1-1: Selection of Monoclonal Antibodies on the Market and in
Advanced Clinical Trials, Derived from Transgenic Rodents
- Table 1-2: Biopharmaceuticals Approved in the United States and the
European Union in 2004
- Figure 1-1: Worldwide Commercial Rodent Model Market Share
- Table 1-3: Selected Companies Focused on Transgenic Biopharmaceutical
Production, 2005
- Table 1-4: Selected Avian-Derived Biopharmaceuticals in Research and
Development
- Table 1-5: A Comparison of Capacity of Transgenic Production Systems
(Productivity and Volume Required for 1,000 Kg of Production)
- Table 1-6: Projected Market for Biopharmaceuticals Produced in Animal and
- Plant Platforms 2006-2015
chapter Two: The Development and Manufacture of Transgenically Produced
Biopharmaceuticals
- Table 2-1: Biopharmaceuticals Approved in the United States and the
European Union in 2004
- Table 2-2: Approval Projections for Therapeutic Monoclonal
- Antibodies, 2005-2008
- Table 2-3: Selected Companies Focused on Transgenic Biopharmacutical
Production, 2005
- Table 2-4: Selected Companies Focused on Plant-Manufactured
- Pharmaceuticals
chapter Three: Transgenic Rodents Developed for Research and Biopharmaceutical
Production
- Table 3-1: Selection of Monoclonal Antibodies on the Market or in Advanced
Clinical Trials, Derived from Transgenic Rodents
- Figure 3-1: Evolution of Antibody Technologies
- Table 3-2: Worldwide Commercial Rodent Model Market 2001-2010
- Figure 3-2: Worldwide Commercial Rodent Model Market Share
chapter four: Transgenically Produced Biopharmaceuticals in Animal and Avian
Platforms
- Table 4-1: Selection of Proteins Expressed in Transgenic Domestic Animals
- Table 4-2: Key Characteristics of Transgenic Animals Used in
Biopharmaceutical Production
- Table 4-3: Selected Animal-Derived Biopharmaceuticals in Research and
- Clinical Trials
- Table 4-4: Selected Avian-derived Biopharmaceuticals in Research and
- Development
chapter five: Transgenically Produced Biopharmaceuticals Manufactured in Plant
Platforms
- Table 5-1: History of Pharmaceutical Proteins Produced In Transgenic
- Plants
- Table 5-2: A Comparison of Capacity of Transgenic Production Systems
(Productivity and Volume Required for 1,000 Kg of Production)
- Table 5-3: A Comparison of Pharmaceutial Expession Systems
- Table 5-4: Major Advantages of Plant Derived Proteins
- Figure 5-1: Timeline for Key Deliverables in a Corn Seed System
- Table 5-5: Number of Field Testing Permits by APHIS by Species and
- Product Type 1991-2004 cumulative
- Table 5-6: Plant-Derived Biopharmaceuticals in Research and Clinical
- Trials
chapter six: Projected Market for Transgenically Produced BioPharmaceuticals
Manufactured in Plant and Animal Platforms
- Figure 6-1: Worldwide Distribution of Competitors by Geography
- Table 6-1: Transgenically Produced Biopharmaceuticals Pending Approval or
in Clinical Phase III and II
- Table 6-2: Projected Market for Biopharmaceuticals Produced in Animal and
- Plant Platforms 2006-2015
chapter Seven: Company Profiles
- Table 7-1: Phase III and Phase II Product Candidates in Clinical
Development
- Figure 7-2: Phase I and Selected Preclinical Product Candidates
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