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Biomedical Sciences - Pharmacology & Toxicology | Sterile Product Development - Formulation, Process, Quality and Regulatory Considerations

Sterile Product Development

Formulation, Process, Quality and Regulatory Considerations

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

2013, XVI, 585 p. 89 illus., 67 illus. in color.

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  • 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

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.

Content Level » Research

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

Related subjects » Biomedical Sciences - Pharmacology & Toxicology

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Distribution rights for India: Mehul Book Sales, Mumbai, India

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