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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Biologie Biochemie & Biophysik Sterile Product Development
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Beschreibung
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated… biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Technische Daten
Erscheinungsdatum
23.08.2016
Sprache
Englisch
EAN
9781493952052
Herausgeber
Springer US
Serien- oder Bandtitel
AAPS Advances in the Pharmaceutical Sciences Series
Sonderedition
Nein
Seitenanzahl
585
Einbandart
Taschenbuch
Buch Untertitel
Formulation, Process, Quality and Regulatory Considerations
Schlagwörter
Development, Formulation, Lyophilized parenterals, PEGylated biotherapeutics, Parenteral drug delivery, Product, Sterile, Sterile filtration
Thema-Inhalt
PNB - Medizinische Chemie, Pharmazeutische Chemie
MBGR - Medizinische Forschung
Höhe
235 mm
Breite
15.5 cm
Hersteller: Humana, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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