Author: Mark C. Via
CHAPTER 1
BACKGROUND AND SCIENTIFIC OVERVIEW: ANTIBODIES AND MONOCLONAL ANTIBODIES
1.1. What Is an Antibody?
1.2. What Is a Monoclonal Antibody?
CHAPTER 2
CURRENT AND EMERGING TECHNOLOGIES: IMPROVING MONOCLONAL ANTIBODY DESIGN AND PRODUCTION
2.1. Key Breakthroughs in the First 35 Years of Monoclonal Antibody Development
Murine-Derived Monoclonal Antibodies
Chimeric Monoclonal Antibodies
Humanized Monoclonal Antibodies
Fully Human Monoclonal Antibodies
Antibody Fragments
Antibody Conjugates
2.2. Monoclonal Antibody Libraries and Display Technologies
Phage Display
MedImmune (AstraZeneca)
Dyax
Crucell
MorphoSys
Affitech
Biosite (Inverness Medical Innovations)
Affimed Therapeutics
XOMA
Ribosome Display
MedImmune (AstraZeneca)
Discerna
Other Library-Based Technologies
Alexion Pharmaceuticals
BioInvent International
Adimab
MSM Protein Technologies
Vaccinex
Morphotek (Eisai Corp. of North America)
AnaptysBio
Sorrento Therapeutics
2.3. Other Technologies for Designing Monoclonal Antibodies
Techniques for Improving Hybridoma Production
Abeome
New Techniques for Generating Animal-Derived Monoclonal Antibodies
GENOVAC (Aldevron)
Epitomics
North Coast Biologics
Xori
Chiome Bioscience
Humanization Technology
Abmaxis (Merck)
Arana Therapeutics
MRC Technology
ImmunoGen
KaloBios Pharmaceuticals
PDL BioPharma
XOMA
Antitope
Xencor
Massachusetts Institute of Technology
Transgenic Mice
Amgen
Medarex
AVANIR Pharmaceuticals
Regeneron Pharmaceuticals
Human Hybridoma Technology
Morphotek (Eisai Corp. of North America)
Patrys
Kenta Biotech
2.4. Alternative Antibody Formats
Antibody Fragments
ESBATech
MacroGenics
Genmab
Synthetic Antibodies
Ablynx
Affibody
Domantis (GlaxoSmithKline)
AdAlta
Enzon Pharmaceuticals/Micromet
Arana Therapeutics
Bispecific Antibodies
Elusys Therapeutics
Micromet
TRION Pharma
Affimed Therapeutics
Affitech/Pharmexa
Biotecnol
Other Antibodies That Enhance Effector Function
BioWa
MacroGenics
Tolerx
Vaccibody
InNexus Biotechnology
Xencor
2.5. Antibody Conjugates
Antibody-Radioisotope Conjugates
Affibody
PBL Therapeutics
Aduro BioTech
Antibody-Drug Conjugates
Medarex
HERMES Biosciences
Celldex Therapeutics
Scancell
Paladin Labs
Antibody-Toxin Conjugates
2.6. Technologies for Improving Monoclonal Antibody Characteristics
Protein Engineering
Applied Molecular Evolution (Eli Lilly)
Arana Therapeutics
Morphotek
MilleGen/Accuro Biologics
Facet Biotech
Xencor
Merus
Algonomics
f-star
PEGylation
Alternatives to PEGylation
Glycosylation
GlycArt (Roche)
GlycoFi (Merck)
Glycotope
Synageva BioPharma
LFB
Alternative Modes of Administration
Altus Pharmaceuticals
Baxter BioPharma Solutions
CHAPTER 3
MARKETED AND EMERGING MONOCLONAL ANTIBODIES: PRESENT AND FUTURE THERAPEUTICS
3.1. Approved Therapeutic Monoclonal Antibodies
Profiles of Therapeutic Monoclonal Antibodies Approved for Marketing
Orthoclone OKT3 (Muromonab-CD3) (1986)
ReoPro (Abciximab) (1994)
Rituxan (Rituximab) (1997)
Zenapax (Daclizumab) (1997)
Simulect (Basiliximab) (1998)
Synagis (Palivizumab) (1998)
Remicade (Infliximab) (1998)
Herceptin (Trastuzumab) (1998)
Mylotarg (Gemtuzumab Ozogamicin) (2000)
Campath (Alemtuzumab) (2001)
Zevalin (Ibritumomab Tiuxetan) (2002)
Humira (Adalimumab) (2002)
Xolair (Omalizumab) (2003)
Bexxar (Tositumomab) (2003)
Raptiva (Efalizumab) (2003)
Erbitux (Cetuximab) (2004)
Avastin (Bevacizumab) (2004)
Tysabri (Natalizumab) (2006)
Lucentis (Ranibizumab) (2006)
Vectibix (Panitumumab) (2006)
Soliris (Eculizumab) (2007)
Cimzia (Certolizumab Pegol) (2008)
Ilaris (Canakinumab) (2009)
3.2. Monoclonal Antibodies in Development for Cancer
Unconjugated Monoclonal Antibodies for Cancer
Genmab
Medarex
Biogen Idec
Genentech
Human Genome Sciences
Pfizer
Wilex
Immunomedics
ImClone Systems (Eli Lilly)
Morphotek (Eisai Corp. of North America)
Antisoma
Micromet
UCB
AVEO Pharmaceuticals
Lpath
Northwest Biotherapeutics
Anti-idiotype Monoclonal Antibodies for Cancer
Menarini Group
Onyvax
Conjugated Monoclonal Antibodies for Cancer
Active Biotech
Antisoma
ImmunoGen
Immunomedics
MedImmune
Seattle Genetics
Celldex Therapeutics/Curagen
3.3. Monoclonal Antibodies in Development for Immunological Diseases
Human Genome Sciences
Novartis
UCB
Amgen
Biogen Idec/Genentech
MedImmune
Genmab
Millennium Pharmaceuticals (Takeda Pharmaceutical)
Medarex
NovImmune
BioTie Therapies
Micromet
ZymoGenetics/Novo Nordisk
Glenmark Pharmaceuticals
CSL
LigoCyte Pharmaceuticals
Sanofi-Aventis/Kyowa Hakko Kirin
3.4. Monoclonal Antibodies in Development for Infectious Diseases
Novartis
MedImmune
Human Genome Sciences
Taimed Biologics
Medarex
Elusys Therapeutics
Emergent BioSolutions
Crucell
Progenics Pharmaceuticals
Roche
Genmab
Theraclone Sciences
iBioPharma
3.5. Monoclonal Antibodies in Development for Cardiovascular Diseases
Ablynx
ThromboGenics/BioInvent International
Affimed Therapeutics
Lexicon Pharmaceuticals
3.6. Other Therapeutic Antibodies in Development
Amgen
Elan/Wyeth
Eli Lilly
Pfizer
Others
CHAPTER 4
BUSINESS AND STRATEGIC OUTLOOK: MARKET POTENTIAL FOR MONOCLONAL ANTIBODIES AND TRENDS IN THE FIELD
4.1. General Trends
4.2. The Market for Therapeutic Monoclonal Antibodies
Cancer: Solid Tumors
Cancer: Non-Hodgkin’s Lymphoma
Immune and Inflammatory Diseases
Transplant Rejection
Rheumatoid Arthritis
Crohn’s Disease
Psoriasis
Lupus
Multiple Sclerosis
Asthma
Other Emerging Markets
Age-Related Macular Degeneration
HIV
Alzheimer’s Disease
CHAPTER 5
Survey Results and Analysis
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES