Sterile Product Development

Formulation, Process, Quality and Regulatory Considerations

  • Parag Kolhe
  • Mrinal Shah
  • Nitin Rathore

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 6)

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Formulation Approaches for Sterile Products

    1. Front Matter
      Pages 1-1
    2. Martin A. Joyce, Leonore C. Witchey-Lakshmanan
      Pages 3-32
    3. Jason D. Ehrick, Samir A. Shah, Charles Shaw, Vitthal S. Kulkarni, Intira Coowanitwong, Samiran De et al.
      Pages 99-144
    4. Kimberly J. Hassett, Pradyot Nandi, Theodore W. Randolph
      Pages 145-164
  3. Process, Container Closure and Delivery Considerations

  4. Regulatory and Quality Aspects

    1. Front Matter
      Pages 357-357
    2. Herb Lutz, Randy Wilkins, Christina Carbrello
      Pages 431-459
    3. Manoj Sharma, Jason K. Cheung, Anita Dabbara, Jonathan Petersen
      Pages 461-474
    4. Gregory W. Hunter
      Pages 475-500
    5. Jeanne Moldenhauer
      Pages 513-534
    6. Jeanne Moldenhauer
      Pages 535-574
  5. Back Matter
    Pages 575-585

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.


Development Formulation Lyophilized parenterals PEGylated biotherapeutics Parenteral drug delivery Product Sterile Sterile filtration

Editors and affiliations

  • Parag Kolhe
    • 1
  • Mrinal Shah
    • 2
  • Nitin Rathore
    • 3
  1. 1.Pharmaceutical R&D-BioTx PharmaceuticalChesterfieldUSA
  2. 2.LifeCell CorporationBridgewaterUSA
  3. 3.Drug Product EngineeringAmgenThousand OaksUSA

Bibliographic information

  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2013
  • Publisher Name Springer, New York, NY
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4614-7977-2
  • Online ISBN 978-1-4614-7978-9
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site
Industry Sectors
Health & Hospitals
Consumer Packaged Goods