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PharmTech.com Trends in Formulation 2022 eBook Pharmaceutical Technology ® 35 The future of biologics drug delivery Lessons learned in recent years, including during the rapid deployment and production of mRNA vaccines to prevent COVID-19, have made the need for inno- vative technologies that optimize drug formulation, delivery, stability, administration, and distribution of biologics apparent. Processing methods and ex- cipients must be considered for different routes of administration to develop characteristics that can overcome biolog ica l ba r r iers a nd i mprove del iv- ery. Non-invasive therapies that are stable at room temperature could eliminate the need for ultra-cold chain refrigeration and reduce logistics costs, mak- ing medicines more accessible globally. More targeted delivery for biologics could also improve the efficacy of these therapies, especially for respiratory diseases. W h i le dr y powder for mu lat ions of fer a logica l solution to overcome t he cha l lenges of liquid de- livery of biologics, not all conventional dry powder techniques are amenable to biologics formulation a nd del iver y. T F F tech nolog y h a s emerged a s a promising par ticle engineering technique for de- veloping dr y powders for pharmaceuticals, which overcome the challenges of other techniques when it comes to temperature stabilit y, water solubilit y, and absorption. TFF has been successfully applied to prepare dr y powders of proteins and biological products, which subsequently maintain their struc- ture and f unctional activit y with optimal aerosol performance and improved thermostabilit y, over- coming cold chain storage limitations. Other dr y powder technologies continue to emerge, including the use of microwave energy as the heat source for sublimation to enable uniform drying and the use of LyoSphere, which can form small beads for easy- to-dispense doses (2). Additional processes such as aseptic spray-freeze dr ying, aseptic spray dr ying, and radiant energ y vacuum technolog y are being studied in an effor t to overcome formulation and manufacturing challenges of biologics (2). As researchers continue to advance biologics to treat diseases, further development of dr y powder technology will be essential to scale up and improve t he deliver y of t hese t herapies to bet ter suppor t access, convenience, and efficacy for patients. References 1. B. de la Torre and F. Albericio, Molecules online, DOI: 10.3390/molecules25030745 (Feb. 9, 2020). 2. Y. Zhang et a l., Adv Drug Deliv Rev. on line, DOI: 10.1016/j.addr.2021.02.011 (March 8, 2021). 3. S. Hu f n a ge l e t a l., KONA Po wde r an d Par t icle J o u r n al on l i n e , D OI: 10.1 4356/ k on a . 202 2010 (Jan. 10, 2022). 4. P. Bäckman et al., ClinPharmacol Ther. online, DOI: 10.1038/clpt.2014.27 (Feb. 6, 2014). 5. S. Nelson and A. Sant, Front. Immunol. online, DOI: 10.3389/fimmu.2021.808527 (Dec. 14, 2021). 6. J. Wang et al., A A PS PharmSciTech. online, DOI: 10.1208/s12249-020-01744-7 (Aug. 5, 2020). 7. H. Xu et a l., Hum Vaccins & Immunother. on line, DOI: 10.1080/21645515.2017.1365995 (Oct. 24, 2017). 8. X. Li et al., J Control Release. online, DOI: 10.1016/j. jconrel.2015.02.035 (April 28, 2015). 9. E. Wilson, J. Luft, and J. DeSimone, Pharmaceutical Research online, DOI: 10.1007/s11095-018-2452-z (Aug. 23, 2018). 10. J. D. Engst rom et a l., Ph a r m Res. on l i ne, DOI: 10.1007/s11095-008-9540-4 (Feb. 21, 2008). 11. M. Li et al., Pharmaceutics online, DOI: 10.3390/ pharmaceutics8020017 (May 20, 2016). 12. J . W a n g e t a l . , B i o R x i v o n l i n e , D O I : 10.1101/2022.04.16.488553 (Apr. 17, 2022). 13. K . O verhof f et a l., Jour nal of D r ug Deliver y S ci- ence and Technology on line, DOI: 10.1016/S1773- 2247(09)50016-0 (Dec. 17, 2014). 14. H . D a o e t a l . , B i o R x i v o n l i n e , D O I : 10.1101/2021.12.06.471411 (Dec. 7, 2021). 15. J. Engstrom et a l., Eur J PharmBiopharm. on line, DOI: 10.1016/j.ejpb.2006.08.005 (Aug. 18, 2006). 16. K. Overhof f et al., Eur J Pharm Biopharm. online, DOI: 10.1016/j.ejpb.2006.07.012 (January 2007). 17. M. Zhang et al., Eur JPharm Biopharm. online, DOI: 10.1016/j.ejpb.2012.06.016 (November 2012). 18. A. Watts et al., Pharm Res. online, DOI: 10.1007/ s11095-012-0922-2 (Nov. 15, 2012). 19. K. AboulFotouh, et al., Int J Pharm. online, DOI: 10.1016/j.ijpharm.2020.119711 (Sept. 25, 2020). 20. S. Tha k kar et a l., J Control Release. on line, DOI: 10.1016/j.jconrel.2018.10.020 (Dec. 28, 2018). 21. C . E m i g e t a l . , B i o R x i v o n l i n e , D O I : 10.1101/2021.10.12.464150 (Oct. 13, 2021). 22. S. Hu f n a g e l e t a l ., I nt J P h a r m . on l i n e , D OI: 10.1016/j.ijpharm.2022.121637 (Apr. 25, 2022). 23. S. Sa ha k ijpijarn et a l., Int J Pharm. on line, DOI: 10.1016/j.ijpx.2021.100073 (December 2021). ■ More targeted delivery for biologics could also improve the efficacy of these therapies, especially for respiratory diseases. Biologics