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Sterile Product Development Formulation, Process, Quality and Regulatory Considerations /

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...

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Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Kolhe, Parag. (Editor, http://id.loc.gov/vocabulary/relators/edt), Shah, Mrinal. (Editor, http://id.loc.gov/vocabulary/relators/edt), Rathore, Nitin. (Editor, http://id.loc.gov/vocabulary/relators/edt)
Format: Electronic eBook
Language:English
Published: New York, NY : Springer New York : Imprint: Springer, 2013.
Edition:1st ed. 2013.
Series:AAPS Advances in the Pharmaceutical Sciences Series, 6
Subjects:
Pharmaceutical technology.
Medicine.
Pharmaceutical Sciences/Technology.
Biomedicine, general.
Online Access:https://doi.org/10.1007/978-1-4614-7978-9
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Table of Contents:
  • Basic Principles of Sterile Product Formulation Development
  • Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins
  • Polymer and Lipid Based Systems for Parenteral Drug Delivery
  • Formulation Approaches and Strategies for PEGylated Biotherapeutics
  • Nasal Delivery
  • Formulation Approaches and Strategies for Vaccines and Adjuvants
  • Challenges in Freeze-Thaw Processing of Bulk Protein Solutions
  • Best Practices for Technology Transfer of Sterile Products: Case Studies
  • Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations
  • Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology
  • Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals
  • Advances in Container Closure Integrity Testing
  • Pen and Autoinjector Drug Delivery Devices
  • Particulate Matter in Sterile Parenteral Products
  • Appearance Evaluation of Parenteral Pharmaceutical Products
  • Sterile Filtration Principles, Best Practices and New Developments
  • Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance
  • Basics of Sterilization Methods
  • Avoiding Common Errors during Viable Microbial Contamination Investigations
  • Validation of Rapid Microbiology Methods (RMMs)
  • Validation of Moist and Dry Heat Sterilization.

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