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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Medizin Pharmazie Principles and Practices of Lyophilization in Product Development and Manufacturing
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Principles and Practices of Lyophilization in Product Development and Manufacturing
(Gebundene Ausgabe, Englisch)
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Beschreibung
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other… pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on “Preservation of Biologicals” comprised of nine chapters written by experts and including case studies. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Technische Daten
Erscheinungsdatum
25.04.2023
Sprache
Englisch
EAN
9783031126338
Herausgeber
Springer International Publishing
Serien- oder Bandtitel
AAPS Advances in the Pharmaceutical Sciences Series
Sonderedition
Nein
Seitenanzahl
623
Einbandart
Gebundene Ausgabe
Schlagwörter
cryopreservation of pharmaceuticals, freeze drying pharmaceuticals, QbD, scale up pharmaceutical processes, biopharmaceuticals, biologics, drying technologies pharmaceutical sciences, antibody drug conjugates, CART (chimeric antigen receptor modified T-Cell), BITES (Bispecific T Cell )
Thema-Inhalt
MQP - Pharmazie, Apotheke
PNB - Medizinische Chemie, Pharmazeutische Chemie
MKG - Pharmakologie
MBGR - Medizinische Forschung
Höhe
279 mm
Breite
21 cm
Transparenz & Sicherheit
Hersteller: Springer, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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