{"product_id":"pat-applied-in-biopharmaceutical-process-cenk-undey-9781439829455","title":"Pat Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-By-Design","description":"\u003cp\u003eAs with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. \u003c\/p\u003e\u003cp\u003eProcess Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. \u003cstrong\u003ePAT Applied in Biopharmaceutical Process Development and Manufacturing \u003c\/strong\u003ecovers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time.\u003c\/p\u003e\u003cp\u003eInvaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Cenk Undey\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1439829454\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781439829455\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/05\/2011\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 328\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.30lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.30h x 6.40w x 0.90d\u003cbr\u003e\u003cbr\u003e\u003cb\u003eReview Citation(s): \u003c\/b\u003e\u003cbr\u003e\u003ci\u003eReference and Research Bk News\u003c\/i\u003e 04\/01\/2012 pg. 248","brand":"Cenk Undey","offers":[{"title":"Hardcover","offer_id":44245257715967,"sku":"9781439829455","price":260.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_1ba15308-c170-4caa-a550-36c72b3240bb.jpg?v=1693927009","url":"https:\/\/www.whiterainbookhouse.com\/products\/pat-applied-in-biopharmaceutical-process-cenk-undey-9781439829455","provider":"WR Book House","version":"1.0","type":"link"}