• 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