I. SCOPE AND METHODOLOGY
II. REPORT SYNOPSIS
1. Prions
Definition
Introduction
Exhibit 1: Mammalian Agents of Spongiform Encephalopathies, ICTVdb Code,
Disease Name, Natural Host, Prion Name and PrP Iso Form
General Definitions
Genetic Disorder
Sporadic Disease
Itarogenic Disease
History of BSE
Animal Feed
Animal Feed Regulations
Concern for Quality of Feed Ingredients with Increase in BSE around the World
Eurofins Forms Strategic Alliance with VLA in UK to Maintain Feed Safety
Plan on Ban of certain Cattle Material from Medical Products to
Protect Against BSE
New Theory Suggests the Origin of Mad Cow Disease to be from Human Beings
Role of WHO in TSE Control
Role of OIE
2. Global Market Analysis
Exhibit 2: Prion Deactivation Technologies - Global Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Exhibit 3: Prion Reduction Filters - Global Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Exhibit 4: BSE Post Mortem Testing - Global Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Exhibit 5: List of Major Global Companies
3. Regional Market Analysis
North America
Analysis by Prion Deactivation Technologies
Exhibit 6: Prion Deactivation Technologies - North American Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 7: Prion Reduction Filters - North American Value Market Estimations & Predictions (2005 - 2015 in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 8: BSE Post Mortem Testing - North American Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
US Allocation of Funds for Food Safety and BSE Research
Harmonization of BSE Management Policies by United States, Canada, and Mexico
Europe
Analysis by Prion Deactivation Technologies
Exhibit 9: Prion Deactivation Technologies - European Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 10: Prion Reduction Filters - European Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 11: BSE Post Mortem Testing - European Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Exhibit 12: Number of Confirmed BSE Cases in Europe (2003-2007)
European Policies on BSE
The Netherlands
New Case of Mad Cow Disease Reported in The Netherlands
Slovenia
Slovenian Authorities Confirm BSE Case Findings
Austria
August 2005, Third Case of Mad Cow Reported in Austria
Switzerland
Swiss Beef Industry Awarded for Managing BSE
EU Commission’s Latest Proposal Reduces BSE Testing Costs
Japan
Analysis by Prion Deactivation Technologies
Exhibit 13: Prion Deactivation Technologies - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 14: Prion Reduction Filters - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 15: BSE Post Mortem Testing - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Rest of World
Analysis by Prion Deactivation Technologies
Exhibit 16: Prion Deactivation Technologies - Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 17: Prion Reduction Filters - Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 18: BSE Post Mortem Testing - Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
III. .MARKET DYNAMICS
World Cattle Demographics
Exhibit 19: World Cattle Population (2000-2006) – By Geographic Regions for North America, Europe, Japan and Rest of World in Million Head (Graphical Representation Included)
1. Market Overview
Prion Deactivation Technologies - Global Market Analysis
Exhibit 20: Prion Deactivation Technologies - Global Value Market Estimations & Predictions (2005 - 2015) by Geographic Regions for Europe, Japan, North America and Rest of World in US$ Million (Graphical Representation Included)
Exhibit 21: Prion Deactivation Technologies - Global Value Market Shares (2009 & 2015) by Geographic Regions for Europe, Japan, North America and Rest of World (Graphical Representation Included)
Prion Reduction Filters - Global Market Analysis
Exhibit 22: Prion Reduction Filters - Global Value Market Estimations & Predictions (2005 - 2015) by Geographic Regions for Europe, North America, Japan and Rest of World in US$ Million (Graphical Representation Included)
Exhibit 23: Prion Reduction Filters - Global Value Market Shares (2009 & 2015) by Geographic Region for Europe, North America, Japan and Rest of World
BSE Post Mortem Testing - Global Market Analysis
Exhibit 24: BSE Post Mortem Testing - Global Value Market Estimations & Predictions (2005 - 2015) by Geographic Regions for Europe, North America, Japan and Rest of World in US$ Million (Graphical Representation Included)
Exhibit 25: BSE Post Mortem Testing - Global Value Market Shares (2009 & 2015) by Geographic Region for Europe, North America, Japan and Rest of World
2. Major Companies in Prions Market
Abbott Laboratories (USA)
Altegen, Inc. (USA)
Beckman Coulter, Inc. (USA)
Bio-Rad Laboratories, Inc. (USA)
Chronix Biomedical GmbH (Germany)
Clinical Data, Inc. (USA)
Covance, Inc. (USA)
More………
3. Major Activities in Prions Industry
ASP Sterrad Technology Approved by AFSSAPS for Total Inactivation of Prions
Neogen Completes Acquisition of GeenSeek Inc.
ProMetic Signs Marketing Agreement with Abraxis BioScience
BTG plc Takes Over Protherics PLC
Gambro BCT Changes Corporate Identity to CaridianBCT
More….
4. Regional Market Analysis
A. North America
Analysis by Prion Deactivation Technologies
Exhibit 26: Prion Deactivation Technologies - North American Value Market Estimations & Predictions (2005 - 2015) by Geographic Region for Canada and United States in US$ Million (Graphical Representation Included)
Exhibit 27: Prion Deactivation Technologies - North American Value Market Shares (2009 & 2015) by Geographic Region for Canada and United States (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 28: Prion Reduction Filters - North American Value Market Estimations & Predictions (2005 - 2015) by Geographic Region for Canada and United States in US$ Million (Graphical Representation Included)
Exhibit 29: Prion Reduction Filters - North American Value Market Shares (2009 & 2015) by Geographic Region for Canada and United States (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 30: BSE Post Mortem Testing - North American Value Market Estimations & Predictions (2005 - 2015) by Geographic Region for Canada and United States in US$ Million (Graphical Representation Included)
Exhibit 31: BSE Post Mortem Testing - North American Value Market Shares (2009 & 2015) by Geographic Region for Canada and United States (Graphical Representation Included)
US Beef Consumption
Exhibit 32: US Beef Market (2002-2007) – Consumption in Billion Pounds (Graphical Representation Included)
US Beef Production
Exhibit 33: US Beef Market (2002-2006) - Production in Billion Pounds (Commercial Carcass Weight) (Graphical Representation Included)
US Beef Exports
Exhibit 34: US Beef Market (2002 - 2007) – Exports in Million Pounds (Commercial Carcass Weight) (Graphical Representation Included)
Exhibit 35: US Beef Market (2002-2007) – Exports in US$ Million (Graphical Representation Included)
South Korea Resumes US Beef Imports
US Packers Consider Re-entry into South Korean Beef Market
Mexico to Resume Trade with US Dairy Heifers
BSE Cases Reported in the US
Only 10 Percent of Cows to be tested for BSE in the US from August
US Lifts Ban on Aged Cattle Imports from Canada
Canadian Beef Markets
Exhibit 36: Canadian Animal Market (2002-2007) –Exports by Beef Products and Live Animal in CAN$ Million (Graphical Representation Included)
Exhibit 37: Canadian Cattle Market (2002 – 2007) – Exports to the US in Number of Head (Graphical Representation Included)
New Incidence of BSE in Canada Reignites US Import Struggle
Exhibit 38: Canadian Beef and Veal Market (2002-2007) – Exports to the US in Billion Pounds (Graphical Representation Included)
Bison in Demand after BSE Crisis Confirmed BSE Cases in North America
Exhibit 39: Number of Confirmed BSE cases in United States and Canada
1997 Canada Feed Ban
Prevalence of BSE in Canada
$39.8 Million to Alberta for New Feed Regulation Implementation
New Regulations for Animal Feed in Canada
Beef Industry in Canada Granted Class Action Suit of Compensation
Safer Designation for Canadian Cattle from World Organization for Animal Health
New Network of Excellence Centers to Study Prion Diseases
Control Measures to Prevent Spread of BSE
Control Measures to Prevent Transmission of BSE to Human
Canada Amends BSE Infection Control Regulations for US Imports
Exhibit 40: BSE Cases Diagnosed in North America (1993-2007)
Exhibit 41: List of Major Companies in North America
B. Europe
European Cattle Demographics
Exhibit 42: European Cattle Population (2000-2006) - by Geographic Regions for UK, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe in Million Head (Graphical Representation Included)
Analysis by Prion Deactivation Technologies
Exhibit 43: Prion Deactivation Technologies - European Value Market Estimations & Predictions (2005 - 2015) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe in US$ Million (Graphical Representation Included)
Exhibit 44: Prion Deactivation Technology - European Value Market Shares (2009 & 2015) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe
Analysis by Prion Reduction Filters
Exhibit 45: Prion Reduction Filters - European Value Market Estimations & Predictions (2005 - 2015) by Geographic Regions for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe in US$ Million
(Graphical Representation Included)
Exhibit 46: Prion Reduction Filters - European Value Market Shares (2009 & 2015) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe
Analysis by BSE Post Mortem Testing
Exhibit 47: BSE Post Mortem Testing - European Value Market Estimations & Predictions (2005 - 2015) by Geographic Regions for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe in US$ Million (Graphical Representation Included)
Exhibit 48: BSE Post Mortem Testing - European Value Market Shares (2009 & 2015) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe
Exhibit 49: Number of Confirmed BSE cases in Europe by Geographic Regions: United Kingdom, France, Ireland, Portugal, Switzerland, Germany (2003-2007)
BSE Cases in the United Kingdom
Measures Taken by United Kingdom to Control BSE
Germany to Modify BSE Testing Regulations
Exhibit 50: List of Major Companies in Europe
C. Japan
Analysis by Prion Deactivation Technologies
Exhibit 51: Prion Deactivation Technologies - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 52: Prion Reduction Filters - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 53: BSE Post Mortem Testing - Japanese Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Exhibit 54: Number of Confirmed BSE Cases in Japan (Graphical Representation Included)
BSE Cases Reported in Japan
Health Ministry Bans Blood Donations in Japan
A New Amendment Proposed by USDA on Import of Boneless Beef from Japan
Japan Re-enforces US Beef Ban
D. Rest of World
Analysis by Prion Deactivation Technologies
Exhibit 55: Prion Deactivation Technologies – Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by Prion Reduction Filters
Exhibit 56: Prion Reduction Filters - Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
Analysis by BSE Post Mortem Testing
Exhibit 57: BSE Post Mortem Testing - Rest of World Value Market Estimations & Predictions (2005 - 2015) in US$ Million (Graphical Representation Included)
IV. PRODUCT /TECHNOLOGY RESEARCH
Introduction
History
Prions Formation
Structure and Organization of Prions
Special Characteristics of Infectious Proteins
Isoforms
PrPC
PrPSc
PrP’s Role in Long-Term Memory
Hypothesis
Characteristics of Prions
Exhibit 58: Comparison of General Characteristics of Classic Virus and Prions
Prion Biosynthesis
Prions Replication
Prion Strains
Species Barrier
Diseases Caused by Prions
Exhibit 59: Diseases caused by Prions in Animals
Characteristics of Transmissible Spongiform Encephalopathy (TSE)
Treatment of TSEs
Transmission and Causes of Prion Diseases
Prion Transmission and Propagation Modes
Metallic Poisoning
Viral Possibilities
Genetics
Sterilization
Prions in Yeast and Other Fungi
Prions - Proteins that Transmit the Mad Cow Disease
Introduction
Relationship between CJD and BSE
Mechanism of the Prion Diseases
Unsolved Puzzle
Effectiveness of Quinacrine for Treating Creutzfeldt-Jakob Disease
Analysis of Pentosan Polysulphate for Treating Prion Diseases
The Difficulty Posed by Blood Brain Barrier
Risks Associated with PPS
Efficacy Evaluation of Intraventricular PPS Administration
Species Barriers for Prions
TSE
Spreading of TSE
Efforts to Control TSE Related Diseases
Effect of TSE Related Diseases on Biopharmaceutical Industry
Development of In Vitro Diagnostics Polyclonals Free from Pathogen of Scrapie and BSE
Genotype
Extensive Monitoring of Disease Pathogens
Conclusion
Transmissible Spongiform Encephalopathy (TSE)
Exhibit 60: List of Prion Diseases and Pathogenesis in Humans
Exhibit 61: List of Prion Disease and Pathogenesis in Animals
Characteristics of TSE
Genetics
Epidemiology
Possible Cure or Vaccine
Research to Treat Prion Diseases
Bovine Spongiform Encephalopathy (BSE)
Source of the Epidemic
Cause
Cases of BSE
Measures to Prevent the Spread of BSE
Prion and BSE - Mad Cow Disease
Mechanism of Conversion of PrPC to PrPSc
Reported Cases of BSE
BSE Testing
The Detection of BSE in Rodents Increases the Need for Research
Regulations
BSE/TSEs Testing Regulations Imposed by European Union
Transmissible Mink Encephalopathy (TME)
TME Related Diseases
Clinical Characteristics of TME Infected Animals
Diagnosis
Prevalence of the Disease
Scrapie
History
Introduction
Epidemiology and Transmission
Clinical Signs
Wool Manufacturing Process - An Effective Route of BSE Propagation
Research
Diagnosis of Scrapie
Immunohistochemical (IHC) Detection
Capillary Electrophoresis Immunoassay
Eradication Program
Exhibit 62: Number of Scrapie Cases Reported in Great Britain (1993-2003)
Scrapie Cases Reported
Feline Spongiform Encephalopathy (FSE)
Introduction
Cause
Common Breeding Age and Occurrence
Common Symptoms
Main Complications Pertaining to the Disease
Methods Employed for Diagnosis of the Disease
Treatment
Prognosis
Action to be taken in Case of Confirmation of the Disease
Chronic Wasting Disease (CWD)
History
Major Consequences of CWD Prevalence
Causative Agent
Clinical Features
Clinical Duration
Characteristics of Chronic Wasting Disease
Diagnosis
Epidemiology
Distribution
Control Strategies
Kuru
History
Introduction
Definition
Transmission
Diagnosis
Treatment
Research
Gerstmann-Sträussler-Scheinker Syndrome (GSS)
Introduction
Cause
Symptoms
Prognosis
Creutzfeldt - Jakob disease
Introduction
Three Major Types of CJD
Sporadic CJD
Hereditary CJD
Acquired CJD
Symptoms of CJD
Clinical Diagnosis of CJD
Treatment
Prions the Causative Agent of CJD
Transmission of CJD
Precautions to Control Spreading of the Disease
Research
CJD-Types and Characteristics
Sporadic CJD
Definition
Variant CJD
vCJD
Definition
Origin of vCJD
Symptoms of vCJD
Differences Between spCJD and vCJD
Differences Between Classic and Variant CJD
Prevalence of vCJD
Genetic CJD
Iatrogenic CJD
Definition
Diagnosis of CJD
EEG
Biomarkers
14-3-3 protein
Sensitivity and Specificity of 14-3-3 Protein Vary With the Form of CJD
SpCJD
vCJD
iCJD
Familial CJD
Metallothionein
Laminin Receptor Protein / Laminin
Sporadic CJD
The EEG
Cerebrospinal Fluid 14-3-3 Analysis
Magnetic Resonance Imaging
Variant CJD
Magnetic Resonance Imaging
Tonsil Biopsy
CSF 14-3-3
Exhibit 63: Number of Reported Cases of vCJD by Country
Genetic CJD
Iatrogenic CJD
Exhibit 64: Referrals of Suspect CJD, Deaths of Definite and Probable CJD
in the United Kingdom
CJD Control Measures in United Kingdom and United States
About Centers for Disease Control and Prevention
Fatal Familial Insomnia (FFI)
Introduction
History
Pathophysiologyof Disease
Disease Progression
Treatment
Relation of FFI with Other Prion Diseases
Common Symptoms and Time Duration Observed in FFI
Diagnostic Procedures for Detection of FFI
Post-mortem Examination
Technologies in Detection of Prions
Immunocapillary Electrophoresis:
Merits and Limitations of ICE as a Screening Test for Prion Diseases
Principle of ICE
Sample Source
ICE Methodology
Parameters
Sensitivity of ICE
Limitations and the Present Status of Screening Test
Heartbeat Clue to Diagnosing vCJD
Conventional Technique
Conformation Dependent Immunoassay
Merits of CDI
Sensitivity
Quantification
Rapid Screening
Early Diagnosis
Other Benefits
Immunoblot (IB)
Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis and Immunoblotting
Immunoblots
Immunoblot Analysis
Histopathology and Immunohistochemistry
Immunohistochemistry
Protein Misfolding Cyclic Amplification (PMCA)
The PMCA Assay
Amplification of rPrPC to rPrPSc in vitro
Amplification Technique Improves Prospects for Diagnostic Tests
Protein-Based PCR for Prion Diseases
Western Blot Assay for TS112
PrP.sup.sen and PrP.sup.112
Electrophoretic Pattern of PrP
Western Blot Assay for PrP
Synthetic Ligands
A Protein-Binding Ligand System for Prion Disease Detection
Scope of the Disease Family
Postmortem Prion Disease Testing
Blood Testing for the Prion Disease Agent
Immuno-PCR
Bio Markers for Detection of Prions (Surrogate Markers)
Prion Infection
Surrogate Markers
Other Assays for Diagnosis of Prion Diseases
Platelia Test (ELISA, Bi121)
Detection
CDI (Inpro)
Histoblot
Paraffin-Embedded Tissue (PET) Blot
ELISA and DELFIA
Rapid Assay
Advantages
RNA Aptamers and Prion Proteins
Aptamers
Prion Protein Binding RNA Aptamer
Interaction of RNA Aptamers with PrPc
RNA Aptamer as a Diagnostic and Therapeutic Agent
Aptamer and Mutations
Transmissible Diseases in Human Plasma
Gradiflow™ Apparatus and its Efficacy
The isolation Process
Final Result
Conclusion
Prion Vaccines
Prion Disease Prevention through Vaccine in Mice
Vaccination
Promising Vaccines against Prion Disease
Toxic Clumps
Gut Reaction
Prion Deactivation Technologies
Prion Inactivation and Decontamination Techniques
Introduction
General Methods of Decontamination
Facility Issues
Device Issues
Prion Inactivation
Prions and its Deactivation Techniques
Exhibit 65: Ineffective or Unreliable Methods of Eradicating Prions
Validation Studies to Analyze Sanitation Practices
Enzyme-Detergent Method for Effective Sterilization of Prion on Surgical Steel
Latest Methodologies Restricting the Infections Caused by
Prion-Contaminated Medical Appliances
Introduction
Available Alternatives or Methodologies
Conditions Normally Used for Inactivating Prions
Conclusion
Analysis
Novel Methods to Restrict Decontamination of Surgical Instruments
Techniques for Inactivation of Prions in Reusable Instruments and Surfaces
Standard Gravity Steam Sterilization Techniques for Treatment of Prion Infections
Methods Effective in Limiting Prion Infectivity
Pre Vacuum Steam Sterilization
Conventional Methods for Inactivation of Prions
Use of NaOH and NaOCl for Chemical Disinfection
Application of Maillard Reaction to Minimize Prion Activation
Clearence Studies
Introduction
Prion Clearence Studies
Prion Inactivation and Removal
Creutzfeldt - Jakob Disease
Bovine Components
Sanitization of Prion
EMEA Clearance
ViruSure
Effective Mode Prion Clearance
The Regulatory Environment
The Nature of the Agent
Spiking Agents
Yardsticks for Clearance
Investigative Steps
Prion Reduction Filters
Evaluation of the Efficacy of Prion Reduction Filters
Core Concerns
TSE Transmission via Blood
Filters to Facilitate Reduction in Prion Proteins
The Effectiveness of the Pall Corporation Filter
UKBS Approach to of Filters
Experimental Models for Endogenous Infectivity in Blood
Donor Species
Prion Strain
Method to Detect Infectivity/PrPSc
Advice Sought From the Committee
Approach to Prevent and Control the Spread of Prion Diseases in Human Beings
Methods to Control the Cause of BSE and Scrapies
Methods for Controlling the Transmission of Prions via Human Plasma Derivatives
Antemortem Prion Diagnosis
Antemortem Diagnosis of CWD (Chronic Wasting Disease)
Development of Aptamer Beacons for Ante-mortem Diagnosis of Chronic Wasting Disease
Antemortem Diagnosis of vCJD
Molecular Diagnosis of vCJD through Ante-mortem Tonsil Biopsy
Antemortem Diagnosis of BSE
Ante-mortem Assays for Infectious Prion Protein
Evaluation Protocol
Evaluation Process
Criteria for Submission of Dossier
Pre-Evaluation Assessment
Criteria for Admission to Full Evaluation
Summary
BSE Post Mortem Testing
Post Mortem BSE Testing
IDEXX HerdChek® Bovine Spongiform Encephalopathy Antigen Test Kit EIA
Overview
Description and Principle
Parts of the Kit
Sampling and Preparation
Step 1
Step 2
Step 3
Step 4
Preparation of Reagents
Wash Solutions 1 and 2
Plate Diluent Component 2
Working Plate Diluent
Negative and Positive Controls
HRPO-Conjugated Anti-PrP Antibody Solution
Acid Stop Solution
Test Procedure
Assay Protocols
Sample Dilution in Working Plate Diluent
Use of Plate Shaker for Sample Incubation Protocols - Short and Ultra-short
Results
Precautions
Safety Information
Post Mortem BSE Testing
Prion Diseases
Post-Mortem Tests
Enfer TSE assay
Principle
Buffers
Merits
Prionics®-Check WESTE
Method
Merits
Prionics®-Check LIA
Method
Merits
Prionics®-Check PrioSTRIP
Method
Merits
Ante-Mortem Tests
Post Mortetm CWD Prion Diagnosis
Prions: Antigen-Capture Enzyme-Linked Immunoassay
Principle of Enzyme-Linked Immunoassay
Protocol of EIA
Merits of EIA
Efficacy of EIA
Collagen
Structural Protein
Function of Collagen in the Human Body
Safety Measures Offered by Collagen
Clinical Perseverance of Collagen Product
Enhanced Performance
Superior Flexibility
Products Derived from Collagen and its Multiple Biomedical Applications
Procedure Followed in the Extraction of Collagen
Properties and Characteristics of Atelocollagen
Additional Characteristics of Atelocollagen
Processing of Atelocollagen to Desired Configurations
Mutable Characteristics of Available Atelocollagen
Superior Quality of KOKEN Atelocollagen
KOKEN Atelocollagen is Absolutely Safe
Application of Collagen in Various Biomedical Applications
Application in Clinical Medicine
Tissue Culture Research
Cosmetics
KOKEN Special-Purpose Atelocollagen Design
Bovine Milk and Milk Pro175
TAFS position paper on the Safety of Bovine Milk and Bovine Milk Products
The Relationship of Prions, PrPc and PrPSc
Bovine Milk Not a Route of BSE Transmission
Ovine Milk and TSE
Prions Risk Assesment
Measuring Risks Related to Prions
Prion Diseases Management Policies
Health Control Policies in UK
European Union and BSE controls
Exhibit 66: Preventive Measures against the Introduction and Spread of BSE in the EU
Japan and BSE
Preface
FDA’s Qualitative Risk Assessment
Proteins from Cattle in Cosmetics
Modes for Transmission of Prions through Cosmetics
Identification of Hazard
Dose-Response Assessment
Characterization of Risk
Inferences
Prions: Animal Bioassays and Cell Culture Assays
Mechanism of Prion Formation
Animal Bioassays
Cell Culture Bioassays
Genetic Engineering Tools
Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathies
via Human and Veterinary Medicinal Products
Regulatory Compliance
Risk Assessment
Legal Aspects
Clarification of Note for Guidance
Scope of the Note for Guidance
Relevant Animal Species
Materials
Seed Lots, Cell Banks and Routine Fermentation/Production
General Considerations
Scientific Principles for Minimising Risk
Source Animals
Geographical Sourcing
Bovine Materials
European Commission Scientific Steering Committee Classification
Sheep and Goats (Small Ruminants)
BSE Negligible Risk (Closed) Bovine Herds
Parts of Animal Bodies, Body Fluids and Secretions as Starting Materials
Age of Animals
Manufacturing Process
Cleaning Process
Validation
Risk Assessment of Materials or Substances Used in the Manufacture and Preparation of a Medicinal Product in the Context of Regulatory Compliance
Risk/Benefit Evaluation
Specific Considerations
Collagen
Gelatin
Bovine Blood Derivatives
Tallow Derivatives
Animal Charcoal
Milk and Milk Derivatives
Wool Derivatives
Amino Acids
Product Trends
A New Fluorescent Molecule Effective in Diagnosing Prion Disease
New Test to Detect Bovine Spongiform Encephalopathy
Hematech - Company Develops New BSE Resistant Cow
Prions - The Outlook
V. CORPORATE DIRECTORY
VI. PATENTS INFORMATION