{"product_id":"gene-therapy-technologies-applications-and-regulations-isbn-9780471967095","title":"Gene Therapy Technologies, Applications and Regulations","description":"Gene Therapy Technologies, Applications and Regulations From Laboratory to Clinic Edited by Anthony Meager Division of Immunobiology, The National Institute for Biological Standards and Control, South Mimms, UK The development of gene-based technologies has been rapid over the past decade and has consequently resulted in a surge of interest in human gene therapy, the deliberate transfer of genes to somatic cells to cure or alleviate disease symptoms. Hundreds of clinical protocols involving variously designed vectors for efficient gene transfer have been developed. However, the use of such complex 'gene medicines' containing potentially heritable genes has raised numerous concerns regarding quality, efficacy and safety. Encompassing recent developments in the field and addressing current concerns this book:\u003cbr\u003e * surveys many of the current technologies for preparing vectors for use in gene therapy protocols\u003cbr\u003e * reviews the application of gene-mediated therapies to a range of medical conditions\u003cbr\u003e * considers the regulatory aspects of gene therapy including product quality and safety requirements\u003cbr\u003e * appraises the transfer of technologies from laboratory to clinic with regard to the attendant requirements and facilities for:\u003cbr\u003e * good laboratory practice (GLP) conditions in the R\u0026amp;D laboratory\u003cbr\u003e * large-scale production methods and good manufacturing practice (GMP)\u003cbr\u003e * current in-process and final product testing\u003cbr\u003e \u003cbr\u003e Written by international experts knowledgeable about many aspects of human somatic gene therapy, this book will be an essential guide for those embarking on gene therapy technologies relevant to specifications of production and testing of products (and procedures) required to meet existing regulations, including quality, efficacy and safety considerations.In der Biomedizin ist die Gentherapie zur Zeit das wohl aufregendste Forschungsgebiet. Sie verfügt über ein vielversprechendes Potential, große medizinische und therapeutische Fortschritte in den kommenden Jahren zu erzielen, wie z.B. die Behandlung von Krankheiten, die bislang als unheilbar galten oder sehr schwierig zu behandeln waren. In diesem maßgeblichen und umfassenden Band sind zum ersten Mal aktuelle Daten zusammengetragen worden, die unterteilt sind in Vorschriften von Gesundheits- und anderen Behörden, Gesetze und Primärliteratur. Enthalten sind Informationen über Technologien der Gentherapie sowie dazugehörende Bestimmungen über behördliche Auflagen von gentechnischen Produkten und Verfahren. Dieser Band leistet einen wichtigen Beitrag zu diesem aktuellen Thema, für das bislang keine maßgebliche Literatur zur Verfügung stand. (10\/99)\u003cbr\u003e Cationic Liposomes for Gene Therapy Applications (J. Clancy \u0026amp; E. Sorscher).\u003cbr\u003e \u003cbr\u003e DNA Condensation and Receptor-mediated Gene Transfer (A. Ziady \u0026amp; T. Ferkol).\u003cbr\u003e \u003cbr\u003e Retroviral Vectors (W. Günzburg \u0026amp; B. Salmons).\u003cbr\u003e \u003cbr\u003e Lentiviral Vectors (A. Lever).\u003cbr\u003e \u003cbr\u003e Adenoviral Vectors (S. Connelly).\u003cbr\u003e \u003cbr\u003e Adeno-associated Viral Vectors (T. Flotte \u0026amp; B. Carter).\u003cbr\u003e \u003cbr\u003e Advances in Engineering HSV Vectors for Gene Transfer to the Nervous System (M. Soares, et al.).\u003cbr\u003e \u003cbr\u003e Mammalian Artificial Chromosomes: Prospects for Gene Therapy (T. Ebersole \u0026amp; C. Farr).\u003cbr\u003e \u003cbr\u003e Gene Therapy for Severe Combined Immunodeficiency (A. Thrasher, et al.).\u003cbr\u003e \u003cbr\u003e Gene Therapy for Haemophilia (R. Hoeben, et al.).\u003cbr\u003e \u003cbr\u003e Cystic Fibrosis: Gene Therapy Approaches (N. Caplen).\u003cbr\u003e \u003cbr\u003e Therapeutic Approaches to Haemoglobinopathies (Y. Beuzard).\u003cbr\u003e \u003cbr\u003e Gene Therapy Approaches to Duchenne Muscular Dystrophy (S. Murphy \u0026amp; G. Dickson).\u003cbr\u003e \u003cbr\u003e Lysosomal Storage Diseases (L. Lashford, et al.).\u003cbr\u003e \u003cbr\u003e Prospects for Gene Therapy of HIV Infections and AIDS (C. Lee, et al.).\u003cbr\u003e \u003cbr\u003e The Developemnt of the Regulatory Process in Europe for Biological Medicines: How it Affects Gene Therapy Products (A. Meager, et al.).\u003cbr\u003e \u003cbr\u003e Developement and Regulation of Gene Therapy Drugs in Germany (K. Cichutek).\u003cbr\u003e \u003cbr\u003e The Transfer of Technology from the Laboratory to the Clinic: In Process Controls and Final Product Testing (F. Borellini \u0026amp; J. Ostrove).\u003cbr\u003e \u003cbr\u003e Good Laboratory Practice in the Research and Development Laboratory (A. Shepherd).\u003cbr\u003e \u003cbr\u003e Facilities for Large-scale Production of Vectors Under GMP Conditions (J. Boyd).\u003cbr\u003e \u003cbr\u003e Addendum.\u003cbr\u003e \u003cbr\u003e Index.  \u003cp\u003e\"It succeeds in putting together, possibly for the first time, gene therapy vectors, clinical applications, and regulatory production issues.\" (\u003cem\u003eHuman Genetics,\u003c\/em\u003e April 2000)  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eAnthony Meager\u003c\/b\u003e is a Principal Scientist in the Division of Immunology and Endocrinology, The National Institute for Biological Standards and Control, UK. Following his PhD in Biochemistry, he has carried out research in biochemistry, cell biology, immunology, virology, and cytokines, especially interferons and tumor necrosis factor. He joined the NIBSC in 1980. Currently, he heads laboratories involved in the biological standardization of IFN and TNF, and research studies on the bioactivity and immunogenicity of cytokines. From 1990, he has also contributed to regulatory guidance on gene therapy, both for the European Medicines Agency and the World Health Organization.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e\u003ci\u003eGene Therapy Technologies, Applications and Regulations From Laboratory to Clinic\u003cbr\u003e\u003c\/i\u003eEdited by Anthony Meager Division of Immunobiology, The National Institute for Biological Standards and Control, South Mimms, UK\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe development of gene-based technologies has been rapid over the past decade and has consequently resulted in a surge of interest in human gene therapy, the deliberate transfer of genes to somatic cells to cure or alleviate disease symptoms. Hundreds of clinical protocols involving variously designed vectors for efficient gene transfer have been developed. However, the use of such complex 'gene medicines' containing potentially heritable genes has raised numerous concerns regarding quality, efficacy and safety. Encompassing recent developments in the field and addressing current concerns this book:\u003c\/p\u003e \u003cul\u003e \u003cli\u003esurveys many of the current technologies for preparing vectors for use in gene therapy protocols\u003c\/li\u003e \u003cli\u003ereviews the application of gene-mediated therapies to a range of medical conditions\u003c\/li\u003e \u003cli\u003econsiders the regulatory aspects of gene therapy including product quality and safety requirements\u003c\/li\u003e \u003cli\u003eappraises the transfer of technologies from laboratory to clinic with regard to the attendant requirements and facilities for:\u003c\/li\u003e \u003cli\u003egood laboratory practice (GLP) conditions in the R\u0026amp;D laboratory\u003c\/li\u003e \u003cli\u003elarge-scale production methods and good manufacturing practice (GMP)\u003c\/li\u003e \u003cli\u003ecurrent in-process and final product testing\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten by international experts knowledgeable about many aspects of human somatic gene therapy, this book will be an essential guide for those embarking on gene therapy technologies relevant to specifications of production and testing of products (and procedures) required to meet existing regulations, including quality, efficacy and safety considerations.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989276180709,"sku":"NP9780471967095","price":436.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780471967095.jpg?v=1761783480","url":"https:\/\/k12savings.com\/es\/products\/gene-therapy-technologies-applications-and-regulations-isbn-9780471967095","provider":"K12savings","version":"1.0","type":"link"}