{"product_id":"regulatory-aspects-of-gene-therapy-and-cell-therapy-products-global","title":"Regulatory Aspects of Gene Therapy and Cell Therapy Products - Global","description":"\u003cp\u003eIn this review the book Regulatory Aspects of Gene Therapy and Cell Therapy Products offers a practical, global survey of how regulatory authorities evaluate innovative gene therapy and cell therapy medicinal products. It is aimed at developers, translational researchers, and regulatory affairs professionals who need a single reference mapping nonclinical to clinical and licensure pathways across regions. The single biggest reason to buy is its chapterbychapter guidance from experts inside national and international bodies, which makes complex regulatory expectations more accessible for product development planning.\u003c\/p\u003e\n\n\u003ch2\u003eKey Features\u003c\/h2\u003e\n\u003cul\u003e\n \u003cli\u003e\n\u003cstrong\u003eGlobal regulatory coverage:\u003c\/strong\u003e Chapters authored by international experts present regulatory pathways across North and South America, Europe, and Asia, helping developers compare regional expectations.\u003c\/li\u003e\n \u003cli\u003e\n\u003cstrong\u003eTranslational focus:\u003c\/strong\u003e The book walks readers through the application of nonclinical research to translational clinical research, clarifying how early studies inform trial design and licensure strategy.\u003c\/li\u003e\n \u003cli\u003e\n\u003cstrong\u003eManufacturing considerations:\u003c\/strong\u003e Practical discussion of product manufacturing highlights critical quality and process aspects that affect regulatory acceptance and product consistency.\u003c\/li\u003e\n \u003cli\u003e\n\u003cstrong\u003ePharmacology and toxicology guidance:\u003c\/strong\u003e Focused insights on safety testing and toxicology approaches tailored to gene and cell therapy platforms support sound preclinical planning.\u003c\/li\u003e\n \u003cli\u003e\n\u003cstrong\u003eClinical trial design insights:\u003c\/strong\u003e Authors describe clinical trial considerations specific to CT and GT products, assisting sponsors in designing trials that meet regulatory expectations.\u003c\/li\u003e\n \u003cli\u003e\n\u003cstrong\u003eRegulatory guidelines synthesis:\u003c\/strong\u003e The book compiles pertinent mustknow guidelines and regulations to serve as a reference for developers preparing submissions.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eWho It's For\u003c\/h2\u003e\n\u003cp\u003eThe book is best suited for regulatory affairs specialists, translational scientists, clinical trial designers, and biotech developers working on gene therapy or cell therapy products who need a crossjurisdictional perspective. It is also valuable for academic investigators transitioning a therapeutic concept toward clinical development and licensure.\u003c\/p\u003e\n\u003cp\u003eReaders who want stepbystep laboratory protocols, extensive case studies with patientlevel outcomes, or a primer on basic genetics may find the book less appropriate; it is focused on regulatory pathways and product development considerations rather than bench protocols or clinical efficacy reviews.\u003c\/p\u003e\n\n\u003ch2\u003ePros \u0026amp; Cons\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003ePros\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n \u003cli\u003eComprehensive international viewpoint that helps compare regulatory expectations between regions.\u003c\/li\u003e\n \u003cli\u003eClear linkage of nonclinical research to translational clinical steps, which aids planning and submission strategy.\u003c\/li\u003e\n \u003cli\u003ePractical coverage of manufacturing, pharmacology, and toxicology elements important to regulators.\u003c\/li\u003e\n \u003cli\u003eAuthored by experts in regulatory bodies, adding authoritative perspective to guidance.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eCons\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n \u003cli\u003eNot a methods manual: it does not replace technical laboratory protocols or stepwise manufacturing SOPs.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eSpecifications\u003c\/h2\u003e\n\u003ctable\u003e\n \u003ctr\u003e\n\u003ctd\u003eTitle\u003c\/td\u003e\n\u003ctd\u003eRegulatory Aspects of Gene Therapy and Cell Therapy Products\u003c\/td\u003e\n\u003c\/tr\u003e\n \u003ctr\u003e\n\u003ctd\u003eSeries\u003c\/td\u003e\n\u003ctd\u003eAdvances in Experimental Medicine and Biology, 871\u003c\/td\u003e\n\u003c\/tr\u003e\n \u003ctr\u003e\n\u003ctd\u003eEditors\/Authors\u003c\/td\u003e\n\u003ctd\u003eMaria Cristina Galli, Mercedes Serabian\u003c\/td\u003e\n\u003c\/tr\u003e\n \u003ctr\u003e\n\u003ctd\u003eScope\u003c\/td\u003e\n\u003ctd\u003eRegulatory pathways and guidelines for gene therapy and cell therapy across multiple regions\u003c\/td\u003e\n\u003c\/tr\u003e\n \u003ctr\u003e\n\u003ctd\u003eTopics covered\u003c\/td\u003e\n\u003ctd\u003eManufacturing, pharmacology, toxicology, clinical trial design, regulatory guidelines\u003c\/td\u003e\n\u003c\/tr\u003e\n \u003ctr\u003e\n\u003ctd\u003eAudience\u003c\/td\u003e\n\u003ctd\u003eRegulatory professionals, translational researchers, biotech developers\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e\n\n\u003ch2\u003eOur Verdict\u003c\/h2\u003e\n\u003cp\u003eRegulatory Aspects of Gene Therapy and Cell Therapy Products is a focused, highvalue reference for professionals navigating regulatory strategy for CT and GT products. Its expertauthored chapters and international scope make it particularly useful for teams seeking to align nonclinical work, manufacturing considerations, and clinical design with regional licensure expectations. It is a worthwhile purchase for developers who need practical regulatory guidance rather than laboratory protocol instruction.\u003c\/p\u003e\n\n\u003ch2\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eDoes this book cover multiple regions?\u003c\/strong\u003e\u003cbr\u003eYes. Chapters provide perspectives on regulatory pathways across North and South America, Europe, and Asia.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eIs it suitable for bench scientists?\u003c\/strong\u003e\u003cbr\u003eIt is most useful for translational and regulatory work; bench scientists looking for detailed lab protocols should look elsewhere.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho authored the chapters?\u003c\/strong\u003e\u003cbr\u003eChapters are written by experts from various national and international regulatory bodies, providing authoritative guidance.\u003c\/p\u003e","brand":"Maria Cristina Galli, Mercedes Serabian","offers":[{"title":"Default Title","offer_id":48609624785115,"sku":"3319357298","price":199.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0724\/1043\/1707\/files\/61gp1mqhaFL._SL1254.jpg?v=1778370679","url":"https:\/\/gearmusthave.com\/products\/regulatory-aspects-of-gene-therapy-and-cell-therapy-products-global","provider":"GearMustHave","version":"1.0","type":"link"}