Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations - Softcover
Book 7 of 38: AAPS Advances in the Pharmaceutical Sciences
Synopsis
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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