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020 _a9783527349470
020 _a9783527833818
_q(electronic bk. : oBook)
020 _a3527833811
_q(electronic bk. : oBook)
024 7 _a10.1002/9783527833818
_2doi
035 _a(OCoLC)1289932184
040 _aDG1
_beng
_erda
_epn
_cDG1
_dOCLCO
_dOCLCF
041 _aeng.
050 4 _aHD9665.5
082 0 4 _a615.19
_223
100 1 _aBehme, Stefan,
_0http://id.loc.gov/authorities/names/nb2009004450
_eauthor.
245 1 0 _aManufacturing of pharmaceutical proteins :
_bfrom technology to economy /
_cStefan Behme.
250 _aThird edition.
264 1 _aWeinheim, Germany :
_bWiley-VCH,
_c2022.
300 _a1 online resource.
336 _atext
_btxt
_2rdacontent.
337 _acomputer
_bc
_2rdamedia.
338 _aonline resource
_bcr
_2rdacarrier.
504 _aIncludes bibliographical references and index.
505 0 _aIntroduction. Biopharmaceutical Production: Value Creation, Product Types, and Biological Basics Introduction -- Technology -- Technology. Manufacturing Process -- Analytics -- Pharmacy -- Pharmacy. Pharmacology and Drug Safety -- Quality Assurance -- Quality Assurance. Fundamentals of Quality Assurance -- Quality Assurance in Manufacturing -- Pharmaceutical Law -- Pharmaceutical Law. Pharmaceutical Law and Regulatory Authorities -- Production Facilities -- Production Facilities. Facility Design -- Planning, Construction, and Commissioning of a Manufacturing Plant -- Economy -- Economy. Production Costs -- Investments -- Production Concept -- Production Organization and Digitalization -- Production Organization and Digitalization. Organization of a Manufacturing Facility -- Digitalization.
520 _aAn expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.
545 0 _aAbout the Author Stefan Behme, PhD, has held several positions within the pharma and biotech industry over the last 20 years with Bayer AG and former Schering AG, Germany. Trained as chemical engineer, his industrial assignments included: managing healthcare investment projects in Germany and the US, biotech manufacturing operations, strategic sourcing of finished pharmaceuticals, and quality assurance in one of the world’s largest drug manufacturing facilities. In parallel he has been passing on his knowledge to students of the Universities of Dortmund (Germany) and Berlin as lecturer for GMP-aspects of biopharmaceutical manufacturing and general life science manufacturing processes. In 2009 he published the first edition of the book “Manufacturing of Pharmaceutical Proteins: from Technology to Economy”, which has developed into a popular reference and was followed by a further expanded edition in 2015.
650 0 _aPharmaceutical industry.
_0http://id.loc.gov/authorities/subjects/sh85039713.
650 0 _aProtein drugs.
_0http://id.loc.gov/authorities/subjects/sh92004729.
655 4 _aElectronic books.
856 4 0 _yFull text available at Wiley Online Library Click here to view.
_uhttps://onlinelibrary.wiley.com/doi/book/10.1002/9783527833818
942 _2ddc
_cER