Principles and Practices of Lyophilization in Product Development and Manufacturing
Language: English
Published by Springer, 2023
- Hardcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 226.50
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Add to basketItem description from seller
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.…
Seller Inventory # 9783031126338
- Title
- Principles and Practices of Lyophilization in Product Development and Manufacturing
- Author
- Feroz Jameel
- Publisher
- Springer
- Publication year
- 2023
- Condition
- Neu
- Binding
- Buch
- Language
- English
- ISBN 10
- 3031126335
- ISBN 13
- 9783031126338
- Item weight
- 1,790 grams
- Dimensions
- 285x215x40 mm
"Synopsis" may belong to another edition of this title.
About the Author
After graduating from University of Connecticut with a Ph.D in Pharmaceutical sciences, Feroz started his carrier with Baxter Biosciences where he was involved in the end-to-end development and tech transfer of lyophilized dosage form of recombinant Factor VIII (RecombinateTM). In 2002, Feroz joined Amgen where he had the opportunity to work on all aspects of drug product development and manufacturing of various modalities including Enbrel®, Nplate®, Repatha® and Blincyto®. In 2016 Feroz joined AbbVie heading the formulation development function of New Biological Entities, Lake County, IL, where he was involved in early and late-stage development of parenteral products. Feroz joined Gilead sciences in January 2021 and was the Director and head of the commercial drug product and formulation. His publications include over 20 peer-reviewed manuscripts, over 20 presentations, and several book chapters. He is the co-editor of the books “Formulation and Process Development Strategies for Manufacturing of Biopharmaceuticals”, “Quality by Design for Biopharmaceutical Drug Product Development” and “Development of Biopharmaceutical Drug Device Products”. He has held several leadership positions at the AAPS including chair of “Freezing and Drying Technologies” and led the industrial consortium for Lyo QbD. Recently, he led the industrial consortium on “Best practices/guidelines for validation of Lyophilization process and products” and published 2 papers. He is a recipient of 2 patents in lyophilization formulation and lyophilization process development. In addition to corporate awards, Henry Kramer from Baxter and Volwiler Award from AbbVie, Feroz received several awards including the AAPS and PDA’s Fred Simon’s award for the best paper published in the PDA Journal of Pharmaceutical Science and Technology.
"About the title" may belong to another edition of this title.
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