Feroz jameel (33 Ergebnisse)

Zustand: New. In.

Zustand: good. Good: The book has been read but is in good condition. It has very minimal damage to the cover, including scuff marks, but no holes or tears. The dust jacket for hard covers may not be included. The binding has minimal wear. The majority of pages are undamaged with minimal creasing or tearing, minimal pencil underlining of text, no highlighting of text, and no writing in the margins. There are no missing pages. See the seller's listing for full details and a description of any imperfections.…

Zustand: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions.…

Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Zustand: New. pp. 984.

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Kartoniert / Broschiert. Zustand: New.

Zustand: New.

Taschenbuch. Zustand: Neu. Principles and Practices of Lyophilization in Product Development and Manufacturing | Feroz Jameel | Taschenbuch | AAPS Advances in the Pharmaceutical Sciences Series | xiii | Englisch | 2024 | Springer | EAN 9783031126369 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.…

Zustand: New. In English.

Zustand: New. In.

Zustand: New. In.

Zustand: New. In.

Zustand: New. In.

Zustand: New. Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization, this book comprehensively covers fundamentals and essential pathways for each production phase as well as the purpose, function, and relat.

Taschenbuch. Zustand: Neu. Quality by Design for Biopharmaceutical Drug Product Development | Feroz Jameel (u. a.) | Taschenbuch | AAPS Advances in the Pharmaceutical Sciences Series | xx | Englisch | 2016 | Humana | EAN 9781493951529 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu. …

Taschenbuch. 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. …

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. …

Kartoniert / Broschiert. Zustand: New.

Gebunden. Zustand: New.

Zustand: Hervorragend. Zustand: Hervorragend | Seiten: 912 | Sprache: Englisch | Produktart: Bücher | 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) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide ¿one stop shopping¿ for the latest information and knowledge of the scientific and engineering advances madeover the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.…

Hardcover. Zustand: Brand New. 1st edition. 984 pages. 10.00x6.50x2.00 inches. In Stock.

Zustand: New. Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization, this book comprehensively covers fundamentals and essential pathways for each production phase; as well as the purpose, function, and relation to other stages in the product development process. Editor(s): Jameel, Feroz; Hershenson, Susan. Num Pages: 976 pages, Illustrations. BIC Classification: TCB; TDCW. Category: (P) Professional & Vocational. Dimension: 242 x 159 x 54. Weight in Grams: 1510. . 2010. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.…

Taschenbuch. Zustand: Neu. Development of Biopharmaceutical Drug-Device Products | Feroz Jameel (u. a.) | Taschenbuch | AAPS Advances in the Pharmaceutical Sciences Series | xviii | Englisch | 2021 | Springer | EAN 9783030314170 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu. …

Paperback. Zustand: Brand New. reprint edition. 730 pages. 9.25x6.10x1.81 inches. In Stock.

Hardcover. Zustand: Brand New. 9.25x6.25x1.50 inches. In Stock.

Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.…

Paperback. Zustand: Brand New. 911 pages. 9.25x6.10x1.80 inches. In Stock.

Hardcover. Zustand: Brand New. 911 pages. 9.25x6.10x2.05 inches. In Stock.

Taschenbuch. 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 as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide 'one stop shopping' for the latest information and knowledge of the scientific and engineering advances madeover the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies.With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. …