Manufacturing of Gene Therapeutics: Methods, Processing, Regulation, and Validation

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Manufacturing of Gene Therapeutics: Methods, Processing, Regulation, and Validation

Manufacturing of Gene Therapeutics: Methods, Processing, Regulation, and Validation

Yazar	: G. Subramanian
Yayınevi	: Springer
ISBN	: 9780306466809
Baskı yılı	: 2001
Sayfa sayısı	: 376
Ağırlık	: 0.72 kg
Stok durumu	: Var Stok detayları
Kargoya teslim	: Aynı gün kargo

Advances in molecular biology and recombinant DNA technology have accelerated progress in many fields of life science research, including gene therapy. A large number of genetic engineering approaches and methods are readily available for gene cloning and therapeutic vector construction. Significant progress is being made in genomic, DNA sequencing, gene expression, gene delivery and cloning. Thus, gene therapy has already shown that it holds great promise for the treatment of many diseases and disorders. In general, it involves the delivery of recombinant genes or transgenes into somatic cells to replace proteins with a genetic defect or to transfer with the pathological process of an illness. The viral and non-viral delivery systems may hold the potential for future non-invasive, cost-effective oral therapy of genetically-based disorders.Recent years have seen considerable progress in the discovery and early clinical development of a variety of gene therapeutic products. The availability, validation, and implementation of gene therapeutic products has also enabled success in testing and evaluation. New challenges will need to be overcome to ensure that products will also be successful in later clinical development and ultimately for marketing authorisation. These new challenges will include improvements in delivery systems, better control of in-vivo targeting, increased level transduction and duration of expression of the gene, and manufacturing process efficiencies that enable reduction in production costs.Perhaps profound understanding of regulated gene design may result in innovative bioproducts exhibiting safety and efficacy profiles that are significantly superior to those achieved by the use of naturally occurring genes. This procedure may contribute considerably to fulfilling standards set by regulatory authorities. This book provides an overview of the current advances in the field of gene therapy and the methods that are being successfully applied in the manufacture of gene therapeutic products, and hopefully will stimulate further progress and advancement in this field to meet the ever-increasing demands.

		Somatic Gene Therapy, Paradigm Shift or Pandoras Box: A Perspective on Gene Therapy by Mark Lawler		1
		Gene Therapy for Cancer: Deceiving the Malignant Cell by Mark Lawler		17
		Gene Self-Assembly (GENSA): Facilitating the Construction of Genes and Vectors by Clague P. Hodgson		33
		Gene Expression by Jaspreet Kaur and Manishi Mukesh and Akshay Anand		45
		Tumour Genotype and Response to Cytotoxic Gene Therapy by Peter T. Daniel and Bernhard Gillissen and Isrid Sturm		59
		Protein Binding Matrices: Tools for Phenol-free Cloning and Vector Assembling by Vladimir I. Evtushenko		99
		Gene Transfer into Eukaryotic Cells by Martin Weber		135
		Plasmid DNA Manufacturing by Martin Schleef and Torsten Schmidt and Karl Friehs		155
		Quality Assurance and Quality Control for Viral Therapeutics by Steven S. Kuwahara		169
		Analytical Assays to Characterise Adenoviral Vectors and Their Applications by Elisabeth Lehmberg and Michael T. McCaman and Joseph A. Traina		201
		Validation of Gene Therapy Manufacturing Processes: A Case Study for Adenovirus Vectors by Dominick Vacante and Gail Sofer and Stephen Morris		227
		Gene Delivery by Akshay Anand		245
		Regulatory Issues in Gene Therapy. Good Science - Good Sense by Nancy Chew and Joy A. Cavagnaro		273
		Regulatory Aspects in Gene Therapy: Special Highlights on European Regulation by Odile Cohen-Haguenhauer		289
		Regulatory Issues for Process Development and Manufacture of Plasmids Under Contract by John M. Jenco		311
		Risk Assessment in Gene Therapy by Akshay Anand and Sunil K. Arora		331
		Index		339

Axess
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL

cardFinans
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL

Bonus
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL

World
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL

Maximum
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL

Paraf
Taksit	Taksit Tutarı	Toplam Tutar
Tek çekim	-	9531.14 TL
2 ay	4932.36 TL	9864.73 TL
3 ay	3351.78 TL	10055.35 TL
6 ay	1787.09 TL	10722.53 TL
9 ay	1270.82 TL	11437.36 TL
12 ay	1028.57 TL	12342.82 TL