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Gene Therapy Technologies, Applications and Regulations by Anthony Meager

By Anthony Meager

Gene remedy applied sciences, purposes and laws From Laboratory to sanatorium Edited by way of Anthony Meager department of Immunobiology, The nationwide Institute for organic criteria and keep an eye on, South Mimms, united kingdom the advance of gene-based applied sciences has been fast over the last decade and has for that reason led to a surge of curiosity in human gene treatment, the planned move of genes to somatic cells to treatment or alleviate illness signs. hundreds of thousands of scientific protocols related to variously designed vectors for effective gene move were constructed. although, using such complicated 'gene medicinal drugs' containing almost certainly heritable genes has raised various issues relating to caliber, efficacy and protection. Encompassing fresh advancements within the box and addressing present issues this publication: * surveys the various present applied sciences for getting ready vectors to be used in gene treatment protocols * reports the applying of gene-mediated treatments to a variety of health conditions * considers the regulatory elements of gene remedy together with product caliber and protection necessities * appraises the move of applied sciences from laboratory to health facility in regards to the attendant requisites and amenities for: * strong laboratory perform (GLP) stipulations within the R&D laboratory * large-scale creation equipment and strong production perform (GMP) * present in-process and ultimate product checking out Written via foreign specialists familiar with many points of human somatic gene treatment, this booklet can be a necessary consultant for these embarking on gene treatment applied sciences appropriate to necessities of creation and checking out of goods (and approaches) required to satisfy current laws, together with caliber, efficacy and protection issues.

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Sample text

Wagner, E. Activation of the complement system by synthetic DNA complexes: a potential barrier for intravenous gene delivery. Hum. Gene Ther. 7(12): 1437–46, 1996. , Mordenti, J. Pharmacokinetics, tissue distribution, and expression efficiency of plasmid [33] DNA following intravenous administration of DNA/cationic lipid complexes in mice: use of a novel radionuclide approach. J. Pharm. Sci. 85(6): 612–18, 1996. F. Immune response in human melanoma after transfer of an allogeneic class I major histocompatibility complex gene with DNA–liposome complexes.

270(42): 24864–70, 1995. , Hashida, M. In vivo disposition characteristics of plasmid DNA complexed with cationic liposomes. J. Drug Targeting 3(2): 149–57, 1995. H. Detailed analysis of structures and formulations of cationic lipids for efficient gene transfer to the lung. Hum. Gene Ther. 7(14): 1701–17, 1996. H. A novel cationic lipid greatly enhances plasmid DNA delivery and expression in mouse lung. Proc. Natl. Acad. Sci. USA 93(21): 11454–9, 1996. , Lehn, P. Gene transfer by guanidinium-cholesterol cationic lipids into airway epithelial cells in vitro and in vivo.

Safety and toxicity of catheter gene delivery to the pulmonary vasculature in a patient with metastatic melanoma. Hum. Gene Ther. 5(9): 1089–94, 1994. , Terada, M. Liposome-mediated in vivo gene transfer of antisense K-ras construct inhibits pancreatic tumor dissemination in the murine peritoneal cavity. Cancer Res. 55(17): 3810–16, 1995. , Huang, L. Inhibition of human ovarian carcinoma cell proliferation by liposome–plasmid DNA complex. Biochem. Biophys. Res. Commun. 207(2): 492– 6, 1995. E. Direct gene transfer with DNA–liposome complexes in melanoma: expression, biologic activity, and lack of toxicity in humans.

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