AAPS Advances in the Pharmaceutical Sciences Series

Sterile Product Development

Formulation, Process, Quality and Regulatory Considerations

Editors: Kolhe, Parag, Shah, Mrinal, Rathore, Nitin (Eds.)

  • 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
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Buy this book

eBook $159.00
price for USA (gross)
  • ISBN 978-1-4614-7978-9
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $209.00
price for USA
  • ISBN 978-1-4614-7977-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $209.00
price for USA
  • ISBN 978-1-4939-5205-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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.

About the authors

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.  

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 product development. Dr. Rathore received his Ph.D. degree in chemical and biological engineering from University of Wisconsin-Madison, Madison, WI.

Table of contents (21 chapters)

  • Basic Principles of Sterile Product Formulation Development

    Joyce, Martin A. (et al.)

    Pages 3-32

  • Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins

    Ramachander, Ranjini (et al.)

    Pages 33-45

  • Polymer- and Lipid-Based Systems for Parenteral Drug Delivery

    Chen, David (et al.)

    Pages 47-60

  • Formulation Approaches and Strategies for PEGylated Biotherapeutics

    Pak, Roger H. (et al.)

    Pages 61-97

  • Considerations for the Development of Nasal Dosage Forms

    Ehrick, Jason D. (et al.)

    Pages 99-144

Buy this book

eBook $159.00
price for USA (gross)
  • ISBN 978-1-4614-7978-9
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $209.00
price for USA
  • ISBN 978-1-4614-7977-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $209.00
price for USA
  • ISBN 978-1-4939-5205-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

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
Series Volume
6
Copyright
2013
Publisher
Springer-Verlag New York
Copyright Holder
American Association of Pharmaceutical Scientists
Distribution Rights
Distribution rights for India: Mehul Book Sales, Mumbai, India
eBook ISBN
978-1-4614-7978-9
DOI
10.1007/978-1-4614-7978-9
Hardcover ISBN
978-1-4614-7977-2
Softcover ISBN
978-1-4939-5205-2
Series ISSN
2210-7371
Edition Number
1
Number of Pages
XVI, 585
Number of Illustrations and Tables
22 b/w illustrations, 67 illustrations in colour
Topics