One: Registration, Toxicity and Quality Control.- 1. Toxicity
testing of rDNA products.- 2. Experiences with the EC "high tech"
procedure.- 3. The regulation of pharmaceuticals: philosophy and
principles.- 4. Quality control of vaccines.- 5. Regulatory affairs
and biotechnology in Europe: the CPMP "high tech" and multistate
procedures.- 6. Formulating biotechnology products.- 7. Development
of analytical methods for monitoring the stability of antibody
formation by hybridoma cells in continuous culture systems.- Two:
Monoclonal Antibodies.- 8. Toward human monoclonal antibodies.- 9.
Biodistribution, binding and internalisation of monoclonal
antibodies to human ovarian carcinoma cells.- 10. Pharmacokinetics
and tissue distribution of Indium-111-labeled OV-TL 3 F(ab')2 in
ovarian cancer patients.- 11. Characterization of human monoclonal
antibodies specific for the rabies virus.- 12. Biochemical and
immunological evaluation of an anti-fibrin monoclonal antibody
complex containing T2Gls Fab' intended for imaging venous thrombi.-
13. Monoclonal antibodies in radioimmunoscintigraphy. Some hurdles
between clone and clinic.- 14. Clinical relevance of the tumor
marker CA 15.3 in the management of cancer patients.- 15. Practical
applications of monoclonal antibodies against polymorphic
epithelial mucin in the differential diagnosis of human tumors.-
16. Selection of monoclonal anti-digoxin antibodies suitable for
monitoring of cardiac glycosides.- 17. Diagnostic use of
anti-modified nucleoside monoclonal antibodies.- 18. Monoclonal
antibodies radiolabeled with different radioisotopes for
biodistribution and radioimmunodetection of tumor xenografts in the
nude rat.- 19. Bispecific monoclonal antibody (BIAB)-retargeted
cellular therapy for local treatment of cancer patients.- 20.
Enhanced binding of t-PA to fibrin using bispecific monoclonal
antibodies.- 21. Recent developments and perspectives on the future
of human and murine monoclonal antibodies in the diagnosis and
treatment of cancer.- 22. Pharmacokinetics and safety of a human
IGM antibody, HA-1A.- 23. Development and clinical experience with
humanised monoclonal antibodies.- 24. A method for the
transformation of hybridoma cell lines with improved efficiency:
its use in the production of bispecific monoclonal antibodies.- 25.
To an optimal design of an airlift bioreactor for the cultivation
of hybridomas.- Three: Marketed Products.- 26. Experience with
marketed biotech products: rt-PA.- 27. Clinical trial of
recombinant human IL-2 in the treatment of Mycobacterium Avium
complex infection.- 28. Use of recombinant human erythropoietin in
anemic dialysis patients.- 29. Experience with biosynthetic growth
hormone.- Four: New Products.- 30. Recombinant follicle stimulating
hormone. I. Construction, selection and characterization of a cell
line.- 31. Recombinant human follicle stimulating hormone. II.
Biochemical and biological characteristics.- 32. Heterologous
expression of human Interleukin-3.- 33. Purification of recombinant
human Interleukin-3 from Bacillus Licheniformis.- 34. The acid- and
thermolabile interferon alpha: a subtype, or a new cell
inhibitor?.- 35. The IFN? receptor as tool for the discovery of new
immunomodulatory drugs.- 36. Cloned receptors and transfected cell
lines in the design of new drugs: muscarinic cholinergic
receptors.- Five: Drug Delivery.- 37. Structural analysis of
carbohydrate chains of native and recombinant-DNA glycoproteins.-
38. The role of protein structure in surface tension kinetics.- 39.
Antigen carriers: a success determining factor for subunit
vaccines?.- 40. Intranasal delivery of insulin: absorption
enhancement by the fusidate derivative STDHF in rabbits and rats
and effects on human nasal ciliary movement in vitro.- 41. Improved
oral peptide delivery by means of mucoadhesion.- 42. Delivery of
therapeutic peptides and proteins.- 43. Compatibility studies of a
soluble T4 receptor with a microinfusion pump for continuous
intravenous thera...
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