Modern Biopharmaceuticals: Design, Development and Optimization is a mammoth work, containing contributions from an impressive group of professionals, including Robert Huber, Thomas Cech, Manfred Eigen Eigen as well as authors from the world's most famous academic institutes and biotech companies.

Modern Biopharmaceuticals describes:

• The first cloned human embryo
• The first myocardial regeneration with embryonic stem cells
• The first artificial kidney
• The first biopharmaceutical from a transgenic animal
• The first individualized medicine
• The first plasma-free Factor VIII
• The first approved human cell line
• The first oral insulin etc
• and much more!

Contents

Volume 1

Part I: Biopharmaceuticals Used in Molecular Medicine

From Genome to Clinic - Correlation Between Genes, Diseases and Biopharmaceuticals

1. Beginning to understand the end of the chromosome
2. The role of pharmacogenetics/pharmacogenomics in drug development
3. Larg-scale detection of genetic variation
4. A systems biology approach to target identification and validation for human chronic disease drug discovery
5. The development of Herceptin®: Paving the way for individualized cancer therapy

siRNA - The Magic Bullet and Other Gene Therapeutical Approaches

6. Adenovirus-based gene therapy
7. MIDGE vectors and dSLIM immunomodulators
8. Nonprotein-coding RNAs and their potential as biopharmaceuticals
9. Double-stranded decoy oligonucleotides as new biopharmaceuticals
10. Rational siRNA design for RNA interference

Mobilis in Mobile - Human Embryonic Stem Cells and Other Sources for Cell Therapy

11. The first cloned human embryo: An unlimited source of stem cells for therapeutic cloning
12. Myocardial regeneration strategies using human embryonic stem cells
13. Gene and cell-based therapies for cardiovascular disease
14. Spheramine®: A cell therapeutic approach to Parkinson's Disease
15. Applying human cells to organogenesis and transplantation

Volume 2

Part II: Biopharmaceuticals and Their Mode of Action

Quid pro Quo - Lysis vs. Coagulation in the Fine-Tuned Balance of the Clotting Cascade

1. Mechanisms of serine proteinase activation
2. Application of the principle of polyvalency to protease inhibition
3. A new tehnology standard for safety and efficacy in Factor VIII replacement therapy

Errare Humanum Est - What Causes Cancer and How to Selectively Fight Tumors

4. Biopharmaceutical drugs from natural sources
5. Biopharmaceuticals as targeting vehicles for In situ radiotherapy of malignancies
6. New directions in tumor therapy

Mundus Vult Decipi - High Mutation Rates of HIV and New Paradigms for Treatment

7. AIDS gene therapy
8. Combinatorial RNA-based therapies for HIV-1

Part III: Improving the Development of Biopharmaceuticals

Citius, Altius, Fortius - Acceleration by High Throughput and Ultra-HT

1. Design of modern biopharmaceuticals by ultra-high-throughput screening and directed evolution
2. Learning from viruses

Early Target Validation - Knock-Out Mice and More

3. Target validation
4. Genetically modified mice in medical and pharmaceutical research
5. An NIH model organism for biopharmaceutical and biomedical research

Revolution by Evolution - Rational Design for Desire and the Scientific Art of Optimization

6. Releasing the spring
7. Accelerating diagnostic product development process with molecular rational design and directed evolution

Volume 3

Part IV: Production of Biopharmaceuticals

The Industry's Workhorses - Mammalian Expression Systems

1. Manufacture of recombinant biopharmaceutical proteins by cultivated mammalian cells in bioreactors
2. Alternative strategies and new cell lines for high-level production of biopharmaceuticals
3. PER.C6® cells for the manufacture of biopharmaceutical proteins
4. Use of the glutamine synthetase (GS) expression system for the rapid development of highly productive mammalian cell processes

Vivat, Crescat, Floreat - A Ripe and Blooming Market for Transgenic Animals and Plants

5. Biopharmaceuticals derived from transgenic plants and animals
6. Production of recombinant proteins in plants
7. Humanized glycosylation
8. ExpressTec: High-level expresion of biopharmaceuticals in cereal grains
9. Biopharmaceutical production in cultured plant cells
10. Producing biopharmaceuticals in the desert
11. The firts biopharmaceutical from transgenic animals: ATryn®

Alea Non Iacta Est - Improving Established Expression Systems

12. Producing modern biopharmaceuticals
13. advanced expression of biopharmaceuticals in yeast at industrial scale
14. Baculovirus-based production of biopharmaceuticals using insect cell culture processes
15. Robust and cost-effective cell-free expression of biopharmaceuticals

When success raises its ugly head - outsourcing to uncork the capacity bottleneck

16. Contract manufacturing of biopharmaceuticals including antibodies of antibody fragments

Part V: Biopharmaceuticals Used for Diagnostics and Imaging

From Hunter to Craftsman - Engineering Antibodies with Nature's Universal Toolbox

1. Thirty years of monoclonal antibodies
2. Modern antibody technology: The impact on drug development
3. Molecular characterization of autoantibody responses in autoimmune diseases

Find, Fight and Follow - Target-Specific Troica from Mother Nature's Pharmacopoiea

4. Molecular imaging and applications for pharmaceutical research and development
5. Design and development of probes for in vivo molecular and functional imaging of cancer and cancer therapies by positron emission tomography (PET)
6. Ligand-based targeting of disease
7. Ultrasound theranostics

Getting Insight - Sense the Urgency for Early Diagnostics

8. Develoment of multi-marker-based diagnostic assays with the ProteinChip® system
9. Early detection of lung cancer

Volume 4

Part VI: Advanced Applications Routes for Bipharrmaceuticals

Getting Inside - Quest for the Best and How to Improve Delivery

1. Advanced drug delivery systems for biopharmaceuticals

Pathfinder - New Ways for Peptides, Proteins & Co

2. Poly(ethylene) glycol conjugates of biopharmaceuticals in drug delivery
3. Novel vaccine adjuvants based on cationic peptide delivery systems
4. The evolving role of Oralin™ in the treatment of diabetes using a novel RapidMist™ diabetes management system
5. Improvement of intestinal absorption of peptide and protein biopharmaceuticals by various approaches

Via Mala - The Stony Road of DNA Delivery: Back-Pack, Feed-Back and Pay-Back

6. DNA vaccine delivery from poly(ortho ester) microspheres
7. Liposomal in vivo gene delivery
8. Programmed packaging

Getting Beyond - Rocket Science and Science Fiction

9. Bionanotechnology and its role to improve biopharmaceuticals

Part VII: From Transcription to Prescription

Dosis Facit Venenum - Therapeutic Window Between Systemic Toxicity and Lack of Efficacy

1. Analytics in quality control and in vivo
2. Design, development and optimization
3. Mettox™

Happy End - Claim to Fame and Approval

4. Consideratons for developing biopharmaceuticals
5. The regulatory environment for biopharmaceuticals in the EU

Part VIII: From Bench to Bedside - The Aftermaths

Think Big and Dealmaking for Growth - Global Changes in the Health-Care Sector

1. Healthcare trends and their impact on the biopharmaceutical industry

News and Views - Quo Vadis, Biopharmaceuticals?

2. mondoBIOTECH: The Swiss biotech BOUTIQUE
3. G-CSF and bioequivalence

Small Molecules - Light at the End of the Tunnel or Back to the Roots?

4. Bioinformatics: From peptides to profiled leads
5. Engineering and overproduction of polyketide natural products

Supplement CD-ROM

Index

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