Sterile Product Development

Language: English

Published by Springer, Humana Okt 2013, 2013

1461479770 / 9781461479772

Series: Book 7 of 38 - AAPS Advances in the Pharmaceutical Sciences

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This item is printed on demand - Print on Demand Titel. Neuware -Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:¿Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines¿Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures¿Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizersThis book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 604 pp. Englisch.

Seller Inventory # 9781461479772

Title
Sterile Product Development
Author
Parag Kolhe
Publisher
Springer, Humana Okt 2013
Publication year
2013
Condition
Neu
Binding
Buch
Language
English
ISBN 10
1461479770
ISBN 13
9781461479772
Item weight
1,062 grams
Dimensions
241x160x38 mm
Series
Book 7 of 38: AAPS Advances in the Pharmaceutical Sciences

buchversandmimpf2000

Emtmannsberg, BAYE, Germany

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AbeBooks seller since January 23, 2017

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