Manufacturing of Gene Therapeutics : Methods, Processing, Regulation, and Validation
Springer Science+Business Media
Explore the cutting edge of gene therapy manufacturing with "Manufacturing of Gene Therapeutics: Methods, Processing, Regulation, and Validation." This comprehensive hardcover book, authored by G. Subramanian, details the latest advances in molecular biology and recombinant DNA technology as applied to gene therapy. It covers essential aspects from gene cloning and vector construction to delivery systems and regulatory validation. Discover how innovative bioproducts are being developed to meet stringent safety and efficacy standards, paving the way for more effective treatments for genetic disorders. This first edition provides an invaluable resource for researchers and professionals seeking to understand and advance the field of gene therapeutics. Key topics include: - Advances in gene cloning and therapeutic vector construction - Viral and non-viral delivery systems for gene therapy - Challenges and solutions in later clinical development and marketing authorization - Improving delivery systems, in-vivo targeting, and gene expression duration - Manufacturing process efficiencies and cost reduction - Regulatory considerations for gene therapeutic products This book is a crucial guide to the methods, processing, regulation, and validation involved in the manufacturing of gene therapeutic products, offering insights into fulfilling the demands of regulatory authorities and advancing patient care.
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