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Books > Science & Mathematics > Biology, life sciences > Biochemistry > Proteins
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Therapeutic Protein Drug Products - Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic (Hardcover)
Loot Price: R3,617
Discovery Miles 36 170
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Therapeutic Protein Drug Products - Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic (Hardcover)
Series: Woodhead Publishing Series in Biomedicine
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Therapeutic protein drug products provides a comprehensive overview
of therapeutic protein drug products, with an emphasis on
formulation beginning in the laboratory, followed by manufacturing
and administration in the clinic. A list of many commercial
therapeutic drug products are described and include the product
name, dosages, active concentration, buffer, excipients, Ph,
container type and route of administration. The laboratory
formulation sections focus on the most common buffers, excipients,
and Ph ranges that are commonly tested in addition to systematic
approaches. A brief section on biophysical and analytical analysis
is also provided. Properties of therapeutic protein formulations
are described and include opalescence, phase separation, color, and
subvisible particles. An emphasis is placed on material and process
testing to ensure success during manufacturing. The drug product
manufacturing process, which includes the process of compounding to
filling, is also covered. Methods of delivery in the clinic are
addressed, as well as delivery strategies. Finally, a perspective
on the regulatory requirements for therapeutic protein formulations
is discussed.
Provides a list and description of commercially available
therapeutic drug products and their formulationsA comprehensive and
practical overview of protein formulation in the laboratory,
manufacturing, and the clinicDiscusses recent topics including high
protein concentration, phase separation, opalescence, and
subvisible particles
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