The preclinical development of monoclonal antibodies and related biological products: new technologies and new therapeutic candidates

Monoclonal antibodies are the fastest growing segment of the pharmaceutical industry, with total annual sales exceed 50 billion dollars over the next four years. 23 in size and three monoclonal antibodies monoclonal antibody fragments have been released to date, several have quickly achieved blockbuster status (annual sales of over $ 1 billion). Between 1995 and 2007, the number of drug candidates based on monoclonal antibodies antibodies in clinical trials have more than tripled, and continues this expansion.

The report explains that monoclonal antibodies, and why the big pharmaceutical companies are investing heavily in the development of medicines for internal and acquisition of these candidates other monoclonal antibodies. More than 80 popular and new technologies are named, explained and illustrated with original color drawings.

The new wave of drug candidates based on these technologies can be seen in the studies more than 200 cases, which are used to identify each commercial enterprise known to have conducted preclinical studies of therapeutic monoclonal antibodies in the last year. Finally, prospects and challenges for the future of this area are discussed, with scientific review of the pioneers and industry leaders.

The main features of this report

• Illustrated "beginners guide to monoclonal antibodies: What do are, how they are doing and why are very promising for the treatment of the disease.

• More than 80 specialties descriptions technologies currently in use the world to select and reorganize the production of monoclonal antibodies.

• Over 30 original color models that illustrate the science and technology monoclonal antibody, as well as appear in nature and the many new forms in the trial in preclinical trials.

Scope of this report

• Understand the basic qualities Monoclonal antibodies and how these qualities translate into drugs only doctors commercial and candidates.

• Understand the challenges and risks of monoclonal antibodies, and its promise.

• Evaluate new technologies promising investment or licensing agreements.

• Identify companies are involved in this area and what they do.

• Provide types drugs that enter clinical trials within the next 1.4 years and can reach the market in the next 5-10 years.

FAQ Key Market

• New monoclonal antibodies can be used to identify new disease processes that are not covered by other treatments, who have access to market areas with high unmet demand.

• The intrinsic specificity and predictability Monoclonal antibodies have been shown to reduce drug development and increase the rate of preclinical and clinical success, compared to non-biological "small molecule" drugs.

• Barriers to entry that currently prevent many new companies entering this field. The techniques used to create, select and modify Monoclonal antibodies used therapeutic rights are protected by copyright, which initially defended vigorously. However, several patents on principle basic expire.

The main conclusions of this report

• In the early challenges related to the immunogenicity of tissue penetration, management and production of monoclonal antibodies are handled by a myriad technologies.

• Advantages competitive identify and address new therapeutic targets to continue to provide incentives for programs targeting and identification of novel antibody monoclonal antibodies.

• Application of techniques to "humanize" nonhuman monoclonal antibodies are still popular, despite the appearance new "fully human" monoclonal antibody technologies. This may be due to the robustness of previous technology and / or deadlines looming patent.

• The methods of genetic engineering and new production systems of the host cells are used to optimize and modify the functions of monoclonal antibodies. proprietary platforms using these methods have been widely licensed to many major players in the biopharmaceutical industry.

Key questions answered

• What are monoclonal antibodies, and what can they do?

• Why why so many companies developing therapeutic agents?

• What companies are working to validate and develop the next generation candidate drugs based on monoclonal antibodies?

• What technological and regulatory challenges facing these companies in developing of these candidates and commercialization of drugs?

Content:

Executive Summary 16

An introduction Monoclonal antibodies to 16

Identify non-human monoclonal antibodies 17

Optimizing long-term antibody 17

Totally 18 human monoclonal antibodies

Conjugated antibodies 19

new molecules derived from antibodies that 20

Chapter Monoclonal antibody-1 Introduction 22

Abstract 22

23 Introduction

Antibodies in the Type 23

Benefits monoclonal antibodies as drugs 29

29 target range

Predictability 30

Pharmacokinetics 30

30 Protection Technology

Challenges and opportunities for the next generation of 31 monoclonal antibodies

The selection of the 31 targets

specificity of 33 species

Pharmacokinetics 34

Manufacturing 34

Monoclonal antibody drug market and 35

Orthoclone OKT3 35

Remicade 36

36 Rituxan

Zenapax 37

Synagis 37

Humira 37

38 Vectibix

38 Simponi

Lucentis 38

39 Cimzia

39 Tysabri

preclinical development of therapeutic drugs 40

Test 40 concept

40 The safety profile

Conclusions 42

Chapter 2 Identification of monoclonal antibodies humans, No 46

Summary 46

Introduction 47

47 Technology Platforms

Hybridoma Technology 48

48 RabMAbs

SLAM 48

Rights intervention Platform 49

49 DIAAD

50 ImmuneY2

50 IMAB

Fusion Technology 51 Expression

51 ProMIS

51 AbScreen

52 AbProt

52 BioArctic platform

52 FunctionFIRST

52 Case Studies

Abbott Labs, 53

53 AbGenomics

Alethia 53

Amorfix 53

54 Arrowsmith Technologies

55 AVEO

55 BioSceptre

Canadian Bio Med Systems 55

Cangene 56

56 CellAct

57 CoGenesys

57 Crucell

CSL 58

Daewoong 58

DKFZ 58

Epitomics 59

Antibody Fusion 59

Ganymed Pharmaceuticals 60

60 GeNeuro

60 Genitope

GSK 61

The heat of organic products 61

Laboratories Immuno-biological, 61

ImmunoGen 62

Immutep 62

63 InflaRx

Innate Pharma 63

Inotek 63

64 Intercell

64 LigoCyte

64 MedImmune

65 Morphotek

65 NeoGenix

Northwest Biotherapeutics 66

Novartis 66

Novo Nordisk 67

67 OncoMed

67 Perseis Therapeutics

68 Pfizer

Pharmaceutical research Toronto 69

Prana Biotechnology 69

Quest PharmaTech 69

69 receptacle Biopharma

Receiver-Logic 70

Roche 70

Shanghai Guoji 71 CP

Biotechnology 71 Stainwei Suzhou

Therapure 71

ThromboGenics 71

72 Thrombotargets

Tolerx 72

Trillium 73

73 Vaccinex

73 Wilex

ZymoGenetics 74

Conclusions 81

Chapter 3 Optimization of the total length of 84 antibodies

Abstract 84

Introduction 85

Technology Platforms 86

antibodies 86 chimeric

CDR grafting 88

SMART 90

90 Superhumanisation

Patch under 91

Composite rights antibodies 91

92 ATLAb

92 Humanization

MLG 93

93 DeImmunisation

Human 93

Human Genius 94

FCX 94

The LEX System 94

94 Potelligent

95 Complegent

97 BestMAb

97 ImmunoBody

EB66 97

98 Synageva expression Platform

98 Xmaben

Sugar 99 antibody engineering

99 Wox

101 Case Studies

Abbott Laboratories 101

Advanced Immune Therapeutics 102

102 Alder Biopharm

Alethia 103

Alexion 103

Antisoma 103

Arana 104

Mitigation 105

106 AVEO

Neuroscience 106 BioArctic

Biogen Idec 106

Biolex 107

BioXell 108

China Synthetic Rubber Corp. 108

CSL 108

109 CureTech

109 DIREVE

DSX 109

110 Eli Lilly

Epitomics 110

Faron Pharm 110

Pharm 110 femte

Forerunner Pharma Research 111

Fusion 111 antibodies

Galaxy 112 Biotechnology

Galileo 112 Oncologica

113 Genentech

Glenmark 113

114 Glycoform

114 Glycotope

Therapeutic immunocellular 114

Immunomedics 115

Innate Pharma 115

InNexus Biotechnology 115

Intellect Neurosciences 116

Isu 116 Abxis

Immunotherapy Alzheimer Janssen 116

KaloBios 117

Pharm 117 Keel

LigoCyte 117

Lpath 117

118 Mabion

MacroGenics 118

119 MaimoniDex

119 MAT Biopharma

MedImmune 119

Medtronic 120

Micromet 120

120 NKT Therapeutics

121 opson

121 thepercipio

122 Toronto Pharmaceutical Research

122 ProTAB

Scancell 123

123 Selexys

Bioscience SinoMab 124

Synageva 124

Taimen 124

Trillium 125

125 United Biomedical

Pharm 125 vascular

126 VasGene

Vegenics 126

126 Vybion

Xencor 127

Conclusions 134

Chapter 4, fully human monoclonal antibody 138

Abstract 138

Introduction 139

Technology Platforms 139

phage display 139

MBAS 141

ACB 142

142 Hucal

Isolated from 142

143 ActivMAb

143 Adimab Platform

143 XenoMouse

145 UltiMAb

145 VelocImmune

Open Monoclonal Technology 146

146 Xenerex

147 SEBVI

Cloning of human response 147

147 Viventi platforms

Natural human antibody 148

148 MabIgX

148 Reverse Translational Medicine

I-STAR 149

149 CellSpot

149 iBioLaunch

150 Case Studies

150 Adimab

Acorda Therapeutics 150

Affitech 151

153 Agensys

153 Alopexx

AstraZeneca 154

155 biofactured

156 Biotherapix

156 CellAct

Celldex 156

157 Centocor

Crucell 158

CSL 158

Dyax 158

Emergent BioSolutions 158

Functional Genetics 159

Genmab 159

Crucell 160

GSK 160

160 Humabs

Male 161 Antibodomics

161 Humanyx

162 Ibio

162 ImClone

IMED 163

163 Immune System Therapeutics

164 IQ Therapeutics

Kenta Biotech 164

Kyowa Hakko Kirin 165

165 MabVax

166 Mapp Biopharmaceutical

Medarex 166

MedImmune 167

168 Merck & Co

Micromet 169

MorphoSys 169

170 NatImmune

170 Neurimmune

170 NovImmune

Novo Nordisk 171

Omeros Corp. 172

172 Oncaidia

OncoMed 172

173 Oxford Biotherapeutics

173 Panacea

174 Patrys

Pilgrim 175

176 PharmAbcine

sanofi-aventis 176

177 Theraclone

Bioscience 178 mesh

U3 Pharma 178

Vaccinex 179

Vegenics 179

Xoma 180

Conclusions 189

Chapter 5-192 conjugated

Abstract 192

Introduction 193

Technology Platforms 193

Antibody drug conjugate 193

Antibody directed load 195 useful

195 Probodies

Antibody 197 cover

Targeted photodynamic therapy 197

198 AlbudAb

hyFc 198

198 Ligand Traps

CovX-200 Body

Dynamic Cross-Linking 200

200 LEC Technology

Studies 201 cases

201 Algete

201 APHI

Armagan Technology 201

Asan Medical Center 202

202 Bayer Schering

Beijing ABT 203

Biogen Idec 203

Biotransformation 203

Boehringer Ingelheim 204

Celldex 204

205 Cytoguide

205 CytomX

206 Dompe

206 EnGeneIC

FDA 206

Forerunner Pharma Research 207

Galileo 207 Oncologica

207 Genentech

208 Genexine

ImmunoGen 208

Immunomedics 209

InNexus Biotechnology 210

Medarex 210

MedImmune 211

Merrimack 211

212 Morphotek

212 Mycenax

212 National Cancer Institute

213 Oncaidia

Science 213 cancer therapy

214 Panacea

214 Pilgrim

Pfizer 214

Pivot 215 BioSciences

Seattle Genetics 215

Symphogen 215

Transgene Biotek 216

216 Viventi

Conclusions 222

Chapter 6 new binding molecules derived from antibodies 224

Abstract 224

Introduction 225

Technology Platforms 226

Fab 226

227 TetraMABs

227 scFv

Immuno 228

scFv [] 2228

BITE 229

Avibodies 230

233 TandAb

234 Flexibody

V-234 NAR

Nanobodies 236

238 domain antibodies

Heteropolymer 242

243 UniBody

Operated field 244 antibody

246 SMIP

SCORPION 247

248 DVD-Ig

Case Studies 249

Abbott Laboratories 249

Ablynx 249

250 Adalto

250 Affimed

251 Avipep

Beijing ABT 251

Biogen Idec 252

252 Calmune

253 Elusys

ESBATech 253

Galileo 253 Oncologica

254 Glycotope

GSK 254

255 Inmunova

256 MAT Biopharma

Micromet 256

Novartis 257

257 PharmAbcine

Trubion 257

Biotechnology Suzhou Stainwei 258

259 Taliga

259 Vegenics

Conclusions 264

Appendix 266

methodology Primary Research 266

267 Glossary

278 Index

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