{"product_id":"process-validation-in-manufacturing-of-biopharmaceuticals-9780367697624","title":"Process Validation in Manufacturing of Biopharmaceuticals","description":"\u003cp\u003eThe fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. \u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Anurag Singh Rathore\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/18\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 392\u003cbr\u003e\u003cb\u003eBinding Type:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.05lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 0.94d\u003cbr\u003e\u003cb\u003eISBN:\u003c\/b\u003e 9780367697624\u003cbr\u003e\u003cp\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eANURAG S. RATHORE is an Institute Chair Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, medical image analysis, process analytical technology and quality by design. He is presently serving as the Editor-in-Chief of \u003ci\u003ePreparative Biochemistry and Biotechnology\u003c\/i\u003e and Associate Editor for \u003ci\u003eJournal of Chemical Technology\u003c\/i\u003e \u003ci\u003eand Biotechnology\u003c\/i\u003e. He also serves on the Editorial Advisory Boards for \u003ci\u003eBiotechnology Progress, Biotechnology Journal, Electrophoresis, BioPharm International\u003c\/i\u003e, \u003ci\u003e Journal of Chromatography B, Journal of Chromatography Open, Pharmaceutical Technology Europe, \u003c\/i\u003eand \u003ci\u003eSeparation and Purification Reviews\u003c\/i\u003e. Dr. Rathore has edited books titled \u003ci\u003ePreparative Chromatography for Separation of Proteins and Peptides (2017), \u003c\/i\u003e \u003ci\u003eQuality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009)\u003c\/i\u003e, \u003ci\u003eElements of Biopharmaceutical Production (2007), Process Validation (2005)\u003c\/i\u003e, \u003ci\u003eElectrokinetic Phenomena (2004), \u003c\/i\u003eand\u003ci\u003e Scale-up and Optimization in Preparative Chromatography (2003)\u003c\/i\u003e. He has a Ph.D. in Chemical Engineering from Yale University. \u003c\/p\u003e\u003cp\u003eHAL BASEMAN is the Chief Operating Officer at ValSource Inc., a consulting services firm. Hal has held various positions in the biopharmaceutical manufacturing and consulting industry and has been involved in sterile product manufacturing for over 45 years. He is the past Chair of the PDA Board of Directors, the past Co-chair of PDA Science Advisory Board, past Chair or Lead on several PDA groups and efforts, including the PDA Process Validation Interest Group, the task forces for PDA Technical Reports on Process Validation, Aseptic Process Simulation, and Quality Risk Management, and the PDA Aseptic Processing Points to Consider. He is currently a member of the PDA TRI (Training and Research Institute faculty, Co-lead for the Kilmer Conference Regulatory Innovation Collaboration team, Chair of the SfSAP (Society for Sterility Assurance Professionals) Aseptic Processing Team, and Co-chair of the PDA Annex 1 revision response team. Hal has presented and published numerous articles and book chapters on topics related to sterile product manufacturing, risk management, and validation. He has edited books on Process Validation and Quality Risk Management. Hal holds a Bachelor of Science Degree in Biology from Ursinus College and a Master of Business Administration in Management from La Salle University.\u003c\/p\u003e\u003cp\u003eDr. Scott Rudge is a Principal Consultant and a member of the Syner-G team since January 2023. He is an experienced pharmaceutical professional with 33 years of progressive experience directing Process Engineering, Process Development, Product Development and overall Pharmaceutical Operations. Scott was a co-founder of RMC Pharmaceutical Solutions in 2004, which was acquired by SynerG Biopharma Group in January, 2023. Scott has built and led several organizations in the biopharmaceutical industry, including process engineering, process development and product development teams at Synergen, Amylin Pharmaceuticals and FeRx, where he reported to the CEO. Ultimately, Scott formed his own consulting company, RMC Pharmaceutical Solutions with the vision to provide product development services to biotech and pharmaceutical companies of all sizes and all stages of development. Scott has remained active as a thought leader and innovator in biotechnology and pharmaceutical development. Scott is a co-author on the award winning textbook \"Bioseparation Science and Engineering\", co-author on the new chapter in Perry's \"Chemical Engineering Handbook\" on Biotechnology, co-editor on the CRC \"Process Validation in Manufacturing of Biopharmaceuticals\", and has been a reviewer for the National Academy of Science's ten year strategic goals for separation sciences in 2020, in addition to many publications and patents. Scott earned his B.S. in Chemical Engineering from Worcester Polytechnic Institute and his M.S. and Ph.D in Chemical Engineering from Purdue University. \u003c\/p\u003e\u003cbr\u003e","brand":"CRC Press","offers":[{"title":"Hardcover","offer_id":43211368988787,"sku":"9.78037E+12","price":390.57,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0555\/9255\/0515\/files\/img_4c387ff7-c087-4770-a467-25861ac5c9f3.jpg?v=1753183525","url":"https:\/\/bookstorenmore.com\/products\/process-validation-in-manufacturing-of-biopharmaceuticals-9780367697624","provider":"Bookstore N More","version":"1.0","type":"link"}