ISBN: 9783031126338 - principles and practices of lyophilization in product development and manufacturing (aaps advances in the pharmaceutical sciences series, 59, band 59) (4 Ergebnisse)

Zustand: NEW.

Zustand: New. In English.

Gebunden. Zustand: New.

Buch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such asAntibody 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 totheir 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 andmanufacturingstarting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques forcharacterization 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 Developmentcontains an entire dedicated section on 'Preservation of Biologicals' comprised of nine chapters written by experts and including case studies. …