{"product_id":"monoclonal-antibodies-meeting-the-challenges-in-manufacturing-formulation-delivery-and-stability-of-final-drug-product-hardback-9780081002964","title":"Monoclonal Antibodies; Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product (Hardback) 9780081002964","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eMonoclonal Antibodies\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eMeeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cem\u003e\u003cp\u003eDiscusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent\u003c\/p\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eSteven Shire (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780081002964, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 23 April 2015\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e224 pages\u003cbr\u003e22.9 x 15.1 x 2 cm, 0.5 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eMonoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies\u003cb\u003e \u003c\/b\u003ediscusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. \u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cul\u003e \u003cli\u003eIntroduction: Pharmaceutical Development\u003c\/li\u003e \u003cli\u003eChapter 1: Current status of monoclonal antibodies in development\u003c\/li\u003e \u003cli\u003eChapter 2:\u003cb\u003e \u003c\/b\u003eStability of mAbs\u003c\/li\u003e \u003cli\u003eRoutes of degradation encountered during processing and storage\u003c\/li\u003e \u003cli\u003eOverview of analytical tools used to characterize and monitor stability\u003c\/li\u003e \u003cli\u003eMethods to evaluate in vivo stability\u003c\/li\u003e \u003cli\u003eChapter 3: Challenges in intravenous (IV) administration\u003c\/li\u003e \u003cli\u003eChapter 4: Challenges in subcutaneous (SC) administration\u003c\/li\u003e \u003cli\u003eChapter 5:\u003cb\u003e \u003c\/b\u003eStrategies to deal with these challenges\u003c\/li\u003e \u003cli\u003eIV strategies\u003c\/li\u003e \u003cli\u003eSC strategies\u003c\/li\u003e \u003cli\u003eChapter 6:\u003cb\u003e \u003c\/b\u003eDevelopment of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration\u003c\/li\u003e \u003cli\u003eChapter 7:\u003cb\u003e \u003c\/b\u003eThe molecular basis of high viscosity of mAbs at high concentration\u003c\/li\u003e \u003cli\u003eChapter 8:\u003cb\u003e \u003c\/b\u003eConclusions \u003c\/li\u003e \u003cli\u003eThe future of mAbs as Therapeutics\u003c\/li\u003e\n\u003c\/ul\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmacology [\u003ca title=\"See our other books on Pharmacology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacology%20%5BMMG%5D%22\"\u003eMMG\u003c\/a\u003e], Immunology [\u003ca title=\"See our other books on Immunology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Immunology%20%5BMJCM%5D%22\"\u003eMJCM\u003c\/a\u003e], Pharmaceutical industries [\u003ca title=\"See our other books on Pharmaceutical industries\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmaceutical%20industries%20%5BKNDP%5D%22\"\u003eKNDP\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Woodhead Publishing","offers":[{"title":"Default Title","offer_id":46648715510040,"sku":"9780081002964","price":103.19,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780081002964_941539bc-db9e-46f7-8b1e-9f54f3ae864b.jpg?v=1695004108","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/monoclonal-antibodies-meeting-the-challenges-in-manufacturing-formulation-delivery-and-stability-of-final-drug-product-hardback-9780081002964","provider":"Freshly Printed Books","version":"1.0","type":"link"}