This up-to-the-minute reference delineates-in a systematic
fashion-the appropriate, sequential steps for the formulation of
safe, effective, stable, and marketable liquid parenteral
biopharmaceutical products-covering fundamentals and essential
pathways for each phase as well as its purpose, function, and
relation to other stages in the product development process.
Written by experts currently involved in state-of-the-art advances
in the pharmaceutical drug industry, Development of
Biopharmaceutical Parenteral Dosage Forms
details biopharmaceuticals that are licensed or undergoing clinical
development, including genetically engineered cell and engineered
vectors in the fermentation process
describes purification and characterization techniques for rDNA
therapeutics, discussing several types of unit operations for
isolation, purification, and characterization
considers preformulation and formulation requirements, such as
physicochemical properties, drug delivery, stability studies
programs, deactivation/denaturation routes, selection of compatible
excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development,
separation methods using chromatographic and electrophoretic
techniques, and bioactivity methods covering bioassays and
immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing
compatibility and minimizing adsorption and inactivation, examining
topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures,
analyzing physical, chemical, toxicological properties, protein
adsorption on elastomeric surfaces, strategies to reduce/eliminate
adsorption, and specialized containers for biotechnological
applications
and more
Furnished with helpful references, tables, and drawings, this
practical guide is indispensable for pharmaceutical, medicinal, and
protein chemists; molecular biologists; process engineers;
purification scientists; biopharmaceutical and pharmaceutical
formulators and product developers; quality control, quality
assurance, and regulatory compliance personnel; and upper-level
undergraduate and graduate students in these disciplines.
General
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