Evolution of Technologies for Therapeutic Antibodies-From mAbs to Biosimilars
The report provides in-depth information on technologicial platforms being developed for monoclonal antibodies and how they have been improvised for biosimilar development. Also various issues pertaining to manufacturing of biosimilars have been highlighted with possible solutions to to address the hurdles.
1 INTRODUCTION
1.1 Study goals and objectives
1.2 Intended audience
1.3 Scope of report
1.4 Questions answered in the report
1.5 Main benefits / Why should you buy this report?
1.6 Information sources
1.7 Analyst credentials
1.8 phamax services
2 SUMMARY10
3 TYPE OF ANTIBODIES CURRENTLY DEVELOPED
3.1 Antiserums
3.2 Targeted therapies
3.3 Chimeric, humanized and fully human antibodies
3.4 Antibody drug conjugates/Immunoconjugates
3.5 Camouflaged antibodies or Probody™
3.6 Bispecific antibodies
3.7 Antibody fragments
3.8 Future of antibody research
3.8.1 Technological developments to understand O-glycosylations
3.8.2 Developments in manufacturing technologies
3.8.3 Development of robust cell lines
3.8.4 Novel antibody-like technology platforms
3.8.5 Targeting cancer stem cells
3.8.6 Formulations and drug delivery systems
4 TECHNOLOGY AND TECHNOLOGICAL PLATFORMS20
4.1 Hybridoma technology
4.2 Genetically engineered antibodies
4.2.1 Genetically engineered mouse
4.2.1.1 HuMAb-Mouse®
4.2.1.2 KM Mouse®
4.2.1.3 VeloCImmune® mouse
4.2.1.4 KyMabTM technology
4.2.1.5 XenoMouse® technology
4.2.2 Targeting the Fc region
4.2.2.1 XmAb®
4.2.3 Note on glycosylations in the human antibodies
4.2.3.1 POTELLIGENT®, COMPLEGENT® and AccretaMab®
4.2.3.2 GlycoMAB®
4.2.3.3 Humanized yeast
4.3 Human origin mAbs
4.3.1 Adjuvants and ethical concerns
4.3.2 Human origin antibody technologies
5 MAJOR BIOSIMILAR ANTIBODIES IN DEVELOPMENT
5.1 Biosimilars: Originators vs Biosimilars
5.1.1 Challenges in establishing biosimilarity
5.1.1.1 Basic concepts in understanding the differences between two drug versions
5.1.1.2 Achilles heel: Understanding the innovator’s product
5.1.1.3 Large number of modified forms: difficulty to get same molecule
5.1.2 Overview of available analytical tools
5.1.3 Current situation of information from analytical tools
5.1.4 Biostatistics in establishing interchangeability
5.2 Potential players in the space and their technologies
5.3 Current pipeline and future development
5.3.1 Infliximab
5.3.2 Adalimumab
5.3.3 Trastuzumab
5.3.4 Rituximab
5.3.4.1 Recently discontinued efforts:
5.3.5 Etnarcept
5.3.5.1 Recently discontinued effort:
5.3.6 Bevacizumab
5.3.7 Ranibizumab
5.4 Drivers and restraints in biosimilar development
5.4.1 Drivers:
5.4.1.1 Increased use of biologics
5.4.1.2 High cost of innovators
5.4.1.3 Government regulations
5.4.1.4 Limited number of players
5.4.1.5 Extrapolated across multiple indications
5.4.1.6 Update in technologies
5.4.2 Restraints:
5.4.2.1 No data for long term effects
5.4.2.2 Lack of technological knowhow of innovator technologies
5.4.2.3 Safety and immunological issues
5.4.2.4 Legal burdens
5.4.2.5 Strong foothold of innovators
5.4.2.6 Reimbursement issues
5.4.2.7 Stakeholder control of substitutions/interchangeability
5.4.3 The current situation
6 CONCLUSION54
7 APPENDIX56
7.1 Adjuvants and their properties
7.2 Bibliography
7.3 Methodology
7.3.1 Secondary research
7.3.2 Data validation
7.4 Disclaimer
7.5 Contact us
1.1 Study goals and objectives
1.2 Intended audience
1.3 Scope of report
1.4 Questions answered in the report
1.5 Main benefits / Why should you buy this report?
1.6 Information sources
1.7 Analyst credentials
1.8 phamax services
2 SUMMARY10
3 TYPE OF ANTIBODIES CURRENTLY DEVELOPED
3.1 Antiserums
3.2 Targeted therapies
3.3 Chimeric, humanized and fully human antibodies
3.4 Antibody drug conjugates/Immunoconjugates
3.5 Camouflaged antibodies or Probody™
3.6 Bispecific antibodies
3.7 Antibody fragments
3.8 Future of antibody research
3.8.1 Technological developments to understand O-glycosylations
3.8.2 Developments in manufacturing technologies
3.8.3 Development of robust cell lines
3.8.4 Novel antibody-like technology platforms
3.8.5 Targeting cancer stem cells
3.8.6 Formulations and drug delivery systems
4 TECHNOLOGY AND TECHNOLOGICAL PLATFORMS20
4.1 Hybridoma technology
4.2 Genetically engineered antibodies
4.2.1 Genetically engineered mouse
4.2.1.1 HuMAb-Mouse®
4.2.1.2 KM Mouse®
4.2.1.3 VeloCImmune® mouse
4.2.1.4 KyMabTM technology
4.2.1.5 XenoMouse® technology
4.2.2 Targeting the Fc region
4.2.2.1 XmAb®
4.2.3 Note on glycosylations in the human antibodies
4.2.3.1 POTELLIGENT®, COMPLEGENT® and AccretaMab®
4.2.3.2 GlycoMAB®
4.2.3.3 Humanized yeast
4.3 Human origin mAbs
4.3.1 Adjuvants and ethical concerns
4.3.2 Human origin antibody technologies
5 MAJOR BIOSIMILAR ANTIBODIES IN DEVELOPMENT
5.1 Biosimilars: Originators vs Biosimilars
5.1.1 Challenges in establishing biosimilarity
5.1.1.1 Basic concepts in understanding the differences between two drug versions
5.1.1.2 Achilles heel: Understanding the innovator’s product
5.1.1.3 Large number of modified forms: difficulty to get same molecule
5.1.2 Overview of available analytical tools
5.1.3 Current situation of information from analytical tools
5.1.4 Biostatistics in establishing interchangeability
5.2 Potential players in the space and their technologies
5.3 Current pipeline and future development
5.3.1 Infliximab
5.3.2 Adalimumab
5.3.3 Trastuzumab
5.3.4 Rituximab
5.3.4.1 Recently discontinued efforts:
5.3.5 Etnarcept
5.3.5.1 Recently discontinued effort:
5.3.6 Bevacizumab
5.3.7 Ranibizumab
5.4 Drivers and restraints in biosimilar development
5.4.1 Drivers:
5.4.1.1 Increased use of biologics
5.4.1.2 High cost of innovators
5.4.1.3 Government regulations
5.4.1.4 Limited number of players
5.4.1.5 Extrapolated across multiple indications
5.4.1.6 Update in technologies
5.4.2 Restraints:
5.4.2.1 No data for long term effects
5.4.2.2 Lack of technological knowhow of innovator technologies
5.4.2.3 Safety and immunological issues
5.4.2.4 Legal burdens
5.4.2.5 Strong foothold of innovators
5.4.2.6 Reimbursement issues
5.4.2.7 Stakeholder control of substitutions/interchangeability
5.4.3 The current situation
6 CONCLUSION54
7 APPENDIX56
7.1 Adjuvants and their properties
7.2 Bibliography
7.3 Methodology
7.3.1 Secondary research
7.3.2 Data validation
7.4 Disclaimer
7.5 Contact us
