June 12 – 17, 2022
Biopharmaceuticals are often intrinsically unstable and can rely on freeze-drying as a standard approach for stabilization. Although a standard, this process has long cycle times, is a batch drying process, and is incompatible with flexible manufacturing. There is need for advancing novel approaches that enable the vision for “a maximally efficient, agile, flexible, manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight;” (2004, FDA Pharmaceutical Quality for the 21st century).
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Justin Stanbro, Akhilesh Bhambhani, Morrisa Jones, Donna Williams, Jeffrey T. Blue, and Tarit Mukhopadhyay, "Enabling technologies for manufacturing thermostable and cost-effective vaccines" in "Vaccine Technology VIII", Tarit Mukhopadhyay, Merck Research Laboratories, USA; Charles Lutsch, Sanofi Pasteur, France; Linda Hwee-Lin Lua, University of Queensland, Australia; Francesc Godia, Universitat Autònoma de Barcelona, Spain Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/vaccine_viii/15