Manufacturing of Gene Therapeutics: Methods, Processing, Regulation, and Validation (Paperback)G. Subramanian (editor)
- We can order this
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.
Publisher: Springer-Verlag New York Inc.
Number of pages: 345
Weight: 563 g
Dimensions: 235 x 155 x 19 mm
Edition: Softcover reprint of the original 1st ed. 200
You may also be interested in...
Please sign in to write a review