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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 59 unit-dose parenteral drugs on a widespread basis, without sacrificing coverage equity or expanding healthcare budgets. In conclusion, BFS may offer the possibility of cre- ating a new segment for the existing injectables mar- ket that is not addressed by the current generation of prefilled syringes for a variety of practical and eco- nomic reasons. Consequently, BFS could enable the fast-growing PFS sector to expand even more rapidly. References 1. FDA, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (CDER, October 2004). 2. F. Leo, et. al., PDA J Pharm Sci Technol, 58(3) 147–58 (May-Jun 2004). 3. NIH, "A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age (MI-CP206)," www.clinicaltrials.gov, accessed April 23, 2021. 4. K. Wrigley, Pharm Tech, 41 (10) 32–35 (October 2017). 5. HHS, "HHS Announces New Public-Private Partnership to Develop U.S.-Based, High-Speed Emergency Drug Packaging Solutions," Press Release (March 18, 2020). 6. PDA, Technical Report No. 77, The Manufacture of Sterile Pharma- ceutical Products Using Blow-Fill-Seal Technology (2017). 7. N. Zadbuke, et. al., J Pharm Bioallied Sci. 5 (2) 98–110 (April 2013). 8. T. Kram and O. Schubert, "Vaccine Packaging with Blow/Fill/Seal Technology: Devices, Vaccine Compatibility and Economic Consid- erations," presentation at the Developing Countries Vaccine Manu- facturers' Network (Kunming, China Oct. 29–Nov. 1, 2018). 9. Y. Lin, et. al., "Feasibility Evaluation of Blow Fill Seal Process and Compatibility with Aluminum Phosphate Adjuvanted Recombinant RSV F Vaccine," Poster presentations for the 11th International Re- spiratory Syncytial Virus Symposium (November 2018). 10. B. Ljungqvist, et. al., PDA J Pharm Sci Technol. 60(4) 254-8 (Jul-Aug 2006). 11. A. Amin, Pharm Tech, 30 (10) (October 2006). 12. Tofflon, "Brief Analysis on Blow-Fill-Seal (BFS) and Its Applications," www.tofflon.com (2012). 13. A. Roberts, "GlaxoSmithKline Australia Boronia Site Uses Blow-Fill- Seal Technology for Vaccines," Herald Sun (Jan. 8, 2016). 14. Industry Research, Global Blow Fill Seal Technology Market Growth 2021 Analysis, Latest Trends, Size, Market Share, Revenue and CAGR Status, Forecast to 2025, Report (March 2021). 15. Report Buyer, Prefilled Syringes Market (4th edition), 2016–2026, Report (April 2017). 16. J. Sedita, et. al., Vaccine 36 (12), 1700–1709 (2018). 17. C. Nogier, et. al., Drugs Real World Outcomes 2 (1) 43–52 (March 2015). 18. S. Makwana, et. al., Int J Pharm Investig. 1(4) 200–6 (October 2011). 19. D. Vaczek, "Promoting Dosing Accuracy with Prefilled Syringes," Packaging Digest (Dec. 11, 2015). PT Next generation Raman imaging High performance Raman systems for a range of applications Visit www.renishaw.com/raman Renishaw, Inc. 1001 Wesemann Drive, West Dundee, Illinois, 60118, United States T +1 847 286 9953 F +1 847 286 9974 E raman@renishaw.com www.renishaw.com Raman spectroscopy produces chemical and structural images to help you understand more about the material being analyzed. Renishaw has decades of experience developing flexible Raman systems that give reliable results, for even the most challenging measurements. With Renishaw's suite of Raman systems, you can see the small things, the large things and things you didn't even know were there. AD216(EN)-01-A (For inc).indd 1 AD216(EN)-01-A (For inc).indd 1 12/20/2019 9:36:12 AM 12/20/2019 9:36:12 AM