Monoclonal antibodies shape the fastest growing segment regarding the pharmaceutical industry, with total annual sales expected to top $50 billion within the next 4 years. 23 full-size monoclonal antibodies and 3 monoclonal antibody fragments have been launched so far, multiple possessing quickly reached blockbuster status' annual sales of over $1 billion. Between 1995 and 2007, the many monoclonal antibody-based drug candidates entering clinical trials higher than tripled, and this expansion is continuing. This report explains what monoclonal antibodies are, and howcome large pharmaceutical businesses are investing so heavily most in developing such drugs internally and acquiring monoclonal antibody candidates from others. Higher than 80 well-known and emerging technologies are named, explained and illustrated with original full-color diagrams.
The newest wave of drug candidates based on these technologies shall be seen in higher than 200 case studies, which identify every commercial business known to have carried out preclinical studies of therapeutic monoclonal antibodies within the final year. Finally, prospects and challenges for the future of this field are discussed, with opinions from scientific pioneers and business leaders. Key features of this report. Illustrated beginners guide' to monoclonal antibodies: What they are, how they can be created and howcome they hold such good promise for the treatment of disease. Higher than 80 descriptions of proprietary technologies currently in use around the globe to select make and re-engineer monoclonal antibodies.
Higher than 30 original, full-color diagrams illustrating the science and technology of monoclonal antibodies, most as they appear in nature and within the myriad new forms now being assessed in preclinical trials. Understand the simple qualities of monoclonal antibodies and how these qualities translate into special medicinal and commercial features for drug candidates. Appreciate the challenges and risks of monoclonal antibodies, as well as their promise. Assess promising new technologies for investment or in-licensing. Identify which businesses are involved in this field, and what they can be doing.
Predict the kinds of drug that shall enter clinical trials within the next 1-4 years and shall reach the market within the next 5-10 years. New monoclonal antibodies shall be used to target new disease processes that are not currently addressed by any other therapies, thereby accessing market regions with high unmet demand. The inherent specificity and predictability of monoclonal antibodies have been shown to shorten drug development times and increase rates of success in preclinical and clinical trials, relative to non-biological mini molecule' drugs. High barriers to entry currently prevent many new businesses from entering this field. The techniques now used to create, select and modify monoclonal antibodies for person therapeutic use are protected by intellectual property, which the originators defend vigorously.
However, multiple early patents on fundamental techniques shall expire very soon. Key findings from this report. Early challenges relating to immunogenicity, tissue penetration, administration and production of monoclonal antibodies are being addressed by myriad new technologies. The competitive benefits of identifying and addressing new therapeutic targets continue to give incentives for new target selection and monoclonal antibody identification programs. Established techniques for humanization' of non-human monoclonal antibodies remain popular, despite the rise of newer fully human' monoclonal antibody technologies.
This should be due to the robust nature regarding the earlier technologies and or or the imminent expiries of key patents. Genetic engineering methods and novel host cell' production processes are being used to optimize and modify functions of monoclonal antibodies. Proprietary platforms creating use of these methods have been widely licensed to many regarding the primary players within the biopharmaceutical industry. Key questions answered. What are monoclonal antibodies, and what can they do?.
Howcome are so many businesses developing them as therapeutic agents?. Which businesses are currently working to validate and develop the final generation of drug candidates based on monoclonal antibodies?. What technological and regulatory challenges face these businesses in developing such candidates and bringing drugs to market?. An introduction to monoclonal antibodies 16. Identifying non-human monoclonal antibodies 17.
Optimizing full-length antibodies 17. Fully person monoclonal antibodies 18. Antibody conjugates 19. Novel binding molecules derived from antibodies 20. Chapter two An introduction to monoclonal antibodies 22.
Antibodies in nature 23. Advantages of monoclonal antibodies as drugs 29. Technology protection 30. Challenges and opportunities for the next generation of monoclonal antibodies 31. Species specificity 33.
Monoclonal antibody drugs already at market 35. Preclinical development of therapeutic drugs 40. Chapter 3 Identifying non-human monoclonal antibodies 46. Technology platforms 47. Hybridoma technology 48.
Human Response Platform 49. Fusion Expression Technology 51. BioArctic platform 52. Arrowsmith Technologies 54. Canadian Bio Med Processes 55.
Ganymed Pharmaceuticals 60. Immuno-Biological Labs 61. Northwest Biotherapeutics 66. Perseis Therapeutics 67. Pharma Studies Toronto 69.
Shanghai CP Guojian 71. Suzhou Stainwei Biotech 71. Chapter 4 Optimizing full-length antibodies 84. Technology platforms 86. Chimeric antibodies 86.
Framework Patching 91. Composite Person Antibody 91. Synageva Expression Platform 98. Sugar Engineered Antibodies 99. Advanced Immune Therapeutics 102.
BioArctic Neuroscience 106. China Synthetic Rubber Corp 108. Forerunner Pharma Studies 111. Fusion Antibodies 111. Galileo Oncologics 112.
ImmunoCellular Therapeutics 114. Intellect Neurosciences 116. Janssen Alzheimer Immunotherapy 116. Pharma Studies Toronto 122. SinoMab Bioscience 124.
United Biomedical 125. Chapter 5 Fully person monoclonal antibodies 138. Technology platforms 139. Open Monoclonal Technology 146. Cloning the Person Response 147.
Viventia platforms 147. Natural Person Antibodies 148. Reverse Translational Medicine 148. Acorda Therapeutics 150. Emergent BioSolutions 158.
Functional Genetics 159. Human Antibodomics 161. Immune System Therapeutics 163. Kyowa Hakko Kirin 165. Mapp Biopharmaceutical 166.
Merck and amp; Co 168. Oxford BioTherapeutics 173. Trellis Bioscience 178. Chapter six Antibody conjugates 192. Technology platforms 193.
Antibody Drug Conjugate 193. Targeted Antibody Payload 195. Antibody cloaking 197. Targeted Photodynamic Therapy 197. Dynamic Cross-Linking 200.
ArmaGen Technologies 201. Asan Medicinal Center 202. BioTransformations 203. Boehringer Ingelheim 204. Forerunner Pharma Studies 207.
Galileo Oncologics 207. OncoTherapy Science 213. Pivotal BioSciences 215. Chapter seven Novel binding molecules derived from antibodies 224. Technology platforms 226.
Domain Antibodies 238. Domain Exchanged Antibodies 244. Galileo Oncologics 253. Suzhou Stainwei Biotech 258. Primary studies methodology 266.
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