Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Co

Description: Drug Development for Gene Therapy by Yanmei Lu, Boris Gorovits Estimated delivery 4-14 business days Format Hardcover Condition Brand New Description Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsidsDetection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy productsNonclinical and clinical study considerations and methods for biodistribution and sheddingQuantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapyDetection and quantification of rAAV integration and off-target editingCurrent regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences. Author Biography Yanmei Lu, PhD is currently the Vice President of Biomarker and BioAnalytical Sciences at Sangamo Therapeutics and previously worked at Genentech. Dr. Lu has a PhD in Biochemistry and Molecular Biology and has published 50+ peer-reviewed articles and book chapters. Boris Gorovits, PhD is currently the Principal at Gorovits BioSolutions, LLC and previously worked at Sana Biotherapeutics, Pfizer and Wyeth Research. Dr. Gorovits has published 80+ journal articles and book chapters. Details ISBN 1119852781 ISBN-13 9781119852780 Title Drug Development for Gene Therapy Author Yanmei Lu, Boris Gorovits Format Hardcover Year 2024 Pages 496 Publisher John Wiley & Sons Inc GE_Item_ID:159142882; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys

Price: 228.69 USD

Location: Calgary, Alberta

End Time: 2024-12-06T03:04:22.000Z

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