0
Your cart

Your cart is empty

Browse All Departments
  • All Departments
Price
  • R5,000 - R10,000 (2)
  • -
Status
Brand

Showing 1 - 2 of 2 matches in All Departments

Development of Biopharmaceutical Drug-Device Products (Paperback, 1st ed. 2020): Feroz Jameel, John W. Skoug, Robert R. Nesbitt Development of Biopharmaceutical Drug-Device Products (Paperback, 1st ed. 2020)
Feroz Jameel, John W. Skoug, Robert R. Nesbitt
R6,716 Discovery Miles 67 160 Ships in 10 - 15 working days

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 made over 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.

Development of Biopharmaceutical Drug-Device Products (Hardcover, 1st ed. 2020): Feroz Jameel, John W. Skoug, Robert R. Nesbitt Development of Biopharmaceutical Drug-Device Products (Hardcover, 1st ed. 2020)
Feroz Jameel, John W. Skoug, Robert R. Nesbitt
R6,749 Discovery Miles 67 490 Ships in 10 - 15 working days

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 made over 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.

Free Delivery
Pinterest Twitter Facebook Google+
You may like...
British Literature (Student) - Cultural…
James Stobaugh Paperback R550 R453 Discovery Miles 4 530
Lamenting Racism Leader's Guide - A…
Rob Muthiah Paperback R411 R329 Discovery Miles 3 290
NASB, The Grace and Truth Study Bible…
R. Albert Mohler Jr Leather / fine binding R2,476 R1,890 Discovery Miles 18 900
Discovering Christian Ministry…
Ron Dalton Paperback R902 R731 Discovery Miles 7 310
America's Story 3 (Student)
Angela O'Dell Paperback R1,150 R920 Discovery Miles 9 200
Jesus in Me Bible Study Guide plus…
Anne Graham Lotz Paperback R612 R506 Discovery Miles 5 060
NIV(r) Standard Lesson Commentary(r…
Standard Publishing Paperback R704 R608 Discovery Miles 6 080
Engaging the Soul of Youth Culture…
Walt Mueller Paperback R525 R429 Discovery Miles 4 290
Seven Things Children Need…
John M. Drescher Paperback R290 R239 Discovery Miles 2 390
Elementary Algebra (Solutions Manual)
Harold R. Jacobs Paperback R530 R436 Discovery Miles 4 360

 

Partners