Overview
- Addresses the key concepts and applications in sterile product area
- Illustrates fundamental understanding as well as practical implications in sterile product development life cycle
- Broad range of in-depth information on numerous topics
- Includes supplementary material: sn.pub/extras
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 6)
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Table of contents (21 chapters)
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Front Matter
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Formulation Approaches for Sterile Products
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Front Matter
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Process, Container Closure and Delivery Considerations
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Front Matter
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Regulatory and Quality Aspects
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Front Matter
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Keywords
About this book
This comprehensive 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 sterilizers
This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Editors and Affiliations
About the editors
Parag Kolhe, Ph.D., is People Leader-Senior Principal Scientist at Pfizer in the department of Biotherapeutic Pharmaceutical Sciences in Chesterfield, MO. His area of work includes formulation, process development, QbD approaches, process validation for late stage vaccine and monoclonal antibody biotech products. He is the author of various peer reviewed publications and patent applications in the area of polymeric drug delivery system and biotherapeutic product development. He received his Ph.D. from Wayne State University in the area of Material Science and Engineering. Â
Mrinal Shah, Ph.D., is a Senior Process Development Engineer within the R&D group at LifeCell Corporation in Bridgewater, NJ where his focus and expertise lies in process design, scale-up, validation and technology transfer for tissue and medical device products. His research experience and interest spans tissue regenerative medication and parenteral and ophthalmic product development. Dr. Shah has authored several peer reviewed publications in the field of phase separation and aggregation in protein solution systems. He received his Ph.D. degree in Chemical & Biomolecular Engineering from the University of Houston and has also been awarded postdoctoral fellowships at Houston Advance Research Center and the Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute.
Nitin Rathore, Ph.D, is a Principal Scientist in Drug Product Process Development at Amgen Inc., Thousand Oaks, California. His group is involved with the development of liquid and lyophilized protein drug products. Dr. Rathore has expertise in the area of formulation, fill & finish and drug delivery including process characterization, scale-up and technology transfer of early to late stage biopharmaceuticals. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug productdevelopment. Dr. Rathore received his Ph.D. degree in chemical and biological engineering from University of Wisconsin-Madison, Madison, WI.Bibliographic Information
Book Title: Sterile Product Development
Book Subtitle: Formulation, Process, Quality and Regulatory Considerations
Editors: Parag Kolhe, Mrinal Shah, Nitin Rathore
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-1-4614-7978-9
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2013
Hardcover ISBN: 978-1-4614-7977-2Published: 13 October 2013
Softcover ISBN: 978-1-4939-5205-2Published: 23 August 2016
eBook ISBN: 978-1-4614-7978-9Published: 12 October 2013
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XVI, 585
Number of Illustrations: 22 b/w illustrations, 67 illustrations in colour
Topics: Pharmaceutical Sciences/Technology, Biomedicine general