Sterile Product Development

Part I. Formulation Approaches for Sterile Products

1. Basic Principles of Sterile Product Formulation Development
Martin A. Joyce, Leonore C. Witchey-Lakshmanan

2. Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins
Ranjini Ramachander, Nitin Rathore

3. Polymer- and Lipid-Based Systems for Parenteral Drug Delivery
David Chen, Sara Yazdi

4. Formulation Approaches and Strategies for PEGylated Biotherapeutics
Roger H. Pak, Rory F. Finn

5. Considerations for the Development of Nasal Dosage Forms
Jason D. Ehrick, Samir A. Shah, Charles Shaw, Vitthal S. Kulkarni, Intira Coowanitwong, Samiran De, Julie D. Suman

6. Formulation Approaches and Strategies for Vaccines and Adjuvants
Kimberly J. Hassett, Pradyot Nandi, Theodore W. Randolph

Part II. Process, Container Closure and Delivery Considerations

7. Challenges in Freeze–Thaw Processing of Bulk Protein Solutions
Hari R. Desu, Sunil T. Narishetty

8. Best Practices for Technology Transfer of Sterile Products: Case Studies
Leonore C. Witchey-Lakshmanan

9. Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations
Benoît Verjans

10. Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology
Benoît Verjans

11. Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals
Edward H. Trappler

12. Advances in Container Closure Integrity Testing
Lei Li

13. Pen and Autoinjector Drug Delivery Devices
Ian Thompson, Jakob Lange

Part III. Regulatory and Quality Aspects

14. Particulate Matter in Sterile Parenteral Products
Satish K. Singh

15. Appearance Evaluation of Parenteral Pharmaceutical Products
Erwin Freund

16. Sterile Filtration: Principles, Best Practices and New Developments
Herb Lutz, Randy Wilkins, Christina Carbrello

17. Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance
Manoj Sharma, Jason K. Cheung, Anita Dabbara, Jonathan Petersen

18. Basics of Sterilization Methods
Gregory W. Hunter

19. Avoiding Common Errors During Viable Microbial Contamination Investigations
Kenneth H. Muhvich

20. Validation of Rapid Microbiological Methods (RMMs)
Jeanne Moldenhauer

21. Validation of Moist and Dry Heat Sterilization
Jeanne Moldenhauer

Keywords: Biomedicine, Pharmaceutical Sciences/Technology, Biomedicine general