Yongchao Su, Merck & Co., Inc., West Point, PA 19486
In 2023, the global market for lyophilized injectables was valued at USD 3.37 billion, with expectations to grow to USD 4.98 billion by 2030.[1] Since freeze-drying was first used on a large scale to stabilize plasma and penicillin during World War II, significant advancements have been made in commercial lyophilization techniques. These developments have made it possible to manufacture fragile therapeutics and distribute shelf-stable medicines globally, leading to the approval and commercialization of hundreds of lyophilized drugs. Although modern freeze-drying has become more efficient, new drying technologies are emerging as potential alternatives to traditional vial-based methods, opening the door to new product types and larger-scale production.[2-4] Additionally, the pharmaceutical community has made great strides in understanding the stability of therapeutics and vaccines in their solid state, driven by modern advancements in material science and biophysical characterization techniques.[5-7]
As the Editor-in-Chief, I encourage you to contribute to the Steven L. Nail Dedicated Issue on Freeze Drying Technology: Recent Advances, Innovations, and Applications.[8] This special issue will explore the latest advancements and future trends in pharmaceutical drying technologies, covering both conventional vial-based freeze-drying and innovative methods such as spray drying, spray freeze-drying, microwave freeze-drying, lyospheres or lyobeads, spin freeze-drying, thin film freeze-drying, foam drying, and microglassification. The issue will also highlight advancements in formulations, processing techniques, analytical methods, equipment design, regulatory compliance, and industry best practices for the development and production of dried pharmaceuticals.
We, along with the Guest Editors [9] and AAPS Open, are thrilled to present this special issue honoring the contributions of Dr. Steven L. Nail, an AAPS Fellow and a global leader in freeze-drying technology.
Deadline to Submit: April 30, 2025
References
[2] Jadhav, K.; Kole, E.; Singh, R.; Rout, S. K.; Verma, R. K.; Chatterjee, A.; Mujumdar, A.; Naik, J. A critical review on developments in drying technologies for enhanced stability and bioavailability of pharmaceuticals. Drying Technology 2024, 42 (9), 1415-1441. DOI: 10.1080/07373937.2024.2357181.
[3] Emami, F.; Keihan Shokooh, M.; Mostafavi Yazdi, S. J. Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals. J Pharm Investig 2023, 53 (1), 35-57. DOI: 10.1007/s40005-022-00610-x.
[4] Chen, Y.; Mutukuri, T. T.; Wilson, N. E.; Zhou, Q. Pharmaceutical protein solids: Drying technology, solid-state characterization and stability. Advanced Drug Delivery Reviews 2021, 172, 211-233. DOI: 10.1016/J.ADDR.2021.02.016.
[5] Ling J.; Du, Y.; Peter Wuelfing W.; Buist, N.; Krishnamachari, Y.; Xi, H.; Templeton, A.C., and Su. Y. Molecular mechanisms for stabilizing biologics in the solid state. DOI: 10.26434/chemrxiv-2024-948wp.
[6]. Preston, K. B.; Randolph, T.W. Stability of lyophilized and spray dried vaccine formulations. Advanced Drug Delivery Reviews 2021 171, 50-61. DOI: 10.1016/j.addr.2021.01.016.
[7] Cicerone, M. T.; Pikal, M. J.; Qian, K. K. Stabilization of proteins in solid form. Advanced Drug Delivery Reviews 2015, 93, 14–24. DOI: 10.1016/j.addr.2015.05.006
[9] Guest Editors: Dr. (Prof.) Alina Alexeenko (Purdue University); Dr. Akhilesh Bhambhani (Ultragenyx); Dr. Bakul Bhatnagar (Pfizer); Dr. (Prof.) Robin Bogner (University of Connecticut); Dr. Shreya Kulkarni (AbbVie); Dr. (Prof.) Xiuling Lu (University of Connecticut); and Dr. Harshil Renawala (Merck). Drs. Kulkarni and Renawala are the co-Lead Guest Editors.