From Clone to Clinic

Front Matter....Pages i-xvi
Toxicity Testing of rDNA Products....Pages 1-11
Experiences with the EC “High Tech” Procedure....Pages 13-19
The Regulation of Pharmaceuticals: Philosophy and Principles....Pages 21-28
Quality Control of Vaccines....Pages 29-35
Regulatory Affairs and Biotechnology in Europe: The CPMP “High Tech” and Multi-State Procedures....Pages 37-43
Formulating Biotechnology Products....Pages 45-55
Development of Analytical Methods for Monitoring the Stability of Antibody Formation by Hybridoma Cells in Continuous Culture Systems....Pages 57-65
Toward Human Monoclonal Antibodies....Pages 67-72
Biodistribution, Binding and Internalisation of Monoclonal Antibodies to Human Ovarian Carcinoma Cells....Pages 73-81
Pharmacokinetics and Tissue Distribution of Indium-111-Labeled OV-TL 3 F(ab’) 2 in Ovarian Cancer Patients....Pages 83-88
Characterization of Human Monoclonal Antibodies Specific for the Rabies Virus....Pages 89-93
Biochemical and Immunological Evalution of an Anti-Fibrin Monoclonal Antibody Complex Containing T2G1s Fab’ Intended for Imaging Venous Thrombi....Pages 95-103
Monoclonal Antibodies in Radioimmunoscintigraphy Some hurdles between clone and clinic....Pages 105-110
Clinical Relevance of the Tumor Marker CA 15.3 in the Management of Cancer Patients....Pages 111-122
Practical Applications of Monoclonal Antibodies Against Polymorphic Epithelial Mucin in the Differential Diagnosis of Human Tumors....Pages 123-133
Selection of Monoclonal Anti-Digoxin Antibodies Suitable for Monitoring of Cardiac Glycosides....Pages 135-141
Diagnostic Use of Anti-Modified Nucleoside Monoclonal Antibodies....Pages 143-148
Monoclonal Antibodies Radiolabeled with Different Radioisotopes for Biodistribution and Radioimmunodetection of Tumor Xenografts in the Nude Rat....Pages 149-157
Bispecific Monoclonal Antibody (Biab)-Retargeted Cellular Therapy for Local Treatment of Cancer Patients....Pages 159-165
Enhanced Binding of t-PA to Fibrin Using Bispecific Monoclonal Antibodies....Pages 167-174
Recent Developments and Perspectives on the Future of Human and Murine Monoclonal Antibodies in the Diagnosis and Treatment of Cancer....Pages 175-188
Pharmacokinetics and Safety of a Human IgM Antibody, HA-1A....Pages 189-194
Development and Clinical Experience with Humanised Monoclonal Antibodies....Pages 195-199
A Method for the Transformation of Hybridoma Cell Lines with Improved Efficiency: Its Use in the Production of Bispecific Monoclonal Antibodies....Pages 201-207
To an Optimal Design of an Airlift Bioreactor for the Cultivation of Hybridomas....Pages 209-217
Experience with Marketed Biotech Products: rt-PA....Pages 219-226
Clinical Trial of Recombinant Human IL-2 in the Treatment of Mycobacterium Avium Avium Complex Infection....Pages 227-232
Use of Recombinant Human Erythropoietin in Anemic Dialysis Patients....Pages 233-238
Experience with Biosynthetic Growth Hormone....Pages 239-243
Recombinant Follicle Stimulating Hormone....Pages 245-251
Recombinant Human Follicle Stimulating Hormone....Pages 253-259
Heterologous Expression of Human Interleukin-3....Pages 261-268
Purification of Recombinant Human Interleukin-3 from Bacillus Licheniformis ....Pages 269-274
The Acid- and Thermolabile Interferon Alpha: A Subtype, or, a New Cell Inhibitor ?....Pages 275-281
The IFNγ Receptor as Tool for the Discovery of New Immunomodulatory Drugs....Pages 283-289
Cloned Receptors and Transfected Cell Lines in the Design of New Drugs: Muscarinic Cholinergic Receptors....Pages 291-294
Structural Analysis of Carbohydrate Chains of Native and Recombinant-DNA Glycoproteins....Pages 295-304
The Role of Protein Structure in Surface Tension Kinetics....Pages 305-313
Antigen Carriers: A Success Determining Factor for Subunit Vaccines?....Pages 315-322
Intranasal Delivery of Insulin: Absorption Enhancement by the Fusidate Derivative STDHF in Rabbits and Rats and Effects on Human Nasal Ciliary Movement in Vitro....Pages 323-328
Improved Oral Peptide Delivery by Means of Mucoadhesion....Pages 329-334
Delivery of Therapeutic Peptides and Proteins....Pages 335-342
Compatibility Studies of a Soluble T4 Receptor with a Microinfusion Pump for Continuous Intravenous Therapy....Pages 343-356
Immunoliposome-Mediated Delivery of Chemotherapeutics....Pages 357-365
A Novel Approach for the Selection and Detection of Cells Transfected with Adenosine Deaminase Expression Vectors....Pages 367-372
Toward Gene Therapy in Hemophilia A: Introduction of Factor VIII Expression Vectors Into Somatic Cells....Pages 373-378
Back Matter....Pages 379-379