The aim of this study is to develop the spray freeze drying process and its hardware and to investigate its capabilities to dry thermosensible substances such as pharma-proteins at normal and low pressures. As the result, the spray freeze fluidized-bed dryer was constructed. During the study, the drying kinetic comparison between classical and spray freeze-drying technologies was done. Spray freeze drying has shown short process times and allows advanced control, product particle shape and size uniformity, and high solubility. This shows that the fluidized-bed freeze-drying process could be an alternative for classical freeze-drying processes. Identified problems are the low yield of the primary drying phase and the strong electrostatic effects during the secondary drying step. However, the innovative process has shown an excellent capability to dry and stabilize the thermosensitive substances, such as pharma-proteins.

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The complexity of biotherapeutics in development continues to increase as our capability in discovery and recombinant technology improves. While safety and efficacy remain the two critical aspects of all therapeutics, ensuring adequate stability is a challenge. Freeze-drying is a commonly-used processing technique to enhance the stability of biotherapeutic products, although the lengthy process time and low energy efficiency have led to the search for, and evaluation of, next-generation drying technologies, including spray freeze-drying and vaccum-foam drying. Both processes result in dosage forms that vary considerably from those produced by lyophilization and possess physical properties that may be deemed superior for their intended applications. Keywords: vacuum-foam drying; spray freeze-drying; lyophilization; biotherapeutics; stabilization

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