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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Development of Biopharmaceutical Drug-Device Products (Hardcover, 1st ed. 2020)
Loot Price: R7,201
Discovery Miles 72 010
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Development of Biopharmaceutical Drug-Device Products (Hardcover, 1st ed. 2020)
Series: AAPS Advances in the Pharmaceutical Sciences Series, 35
Expected to ship within 12 - 19 working days
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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.
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