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Protein Formulation and Delivery Eugene J. McNally

Protein Formulation and Delivery

Eugene J. McNally

Published 2000
ISBN : 9780824778835
Hardcover
262 pages
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 About the Book 

This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of proteinMoreThis handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development.Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stabilityOrganized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Deliveryincludes a discussion of accelerated stability testing and its limitations in identifying stable formulationsdetails analytical methods commonly used in stability assessment and formulation developmentstresses the importance of demonstrating the stability-indicating nature of an assaydescribes the drug substance manufacturing process succinctlyexamines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administrationcovers aseptic processing in drug development and the potential development of a freeze-drying cycleexplores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage formsdiscusses the physical and chemical characteristics of proteins in microsphere delivery systemsanalyzes protein degradation mechanisms, and methods of detecting and monitoring degradationexplores formulations intended for injection, inhalation, and controlled deliveryand morePresenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists- drug regulatory affairs personnel- biotechnologists- formulation, analytical, and synthetic chemists and engineers- and upper-level undergraduate and graduate students in these disciplines.