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The study investigates the development of a nasal formulation comprising a novel antibody for SARS-CoV-2 prophylactic treatment. The study assesses the possibility of delivering the antibody to the nose using an Aptar VP3 pump. Two formulations were manufactured at two levels of protein concentration (20 and 2 mg/mL). These proved to be suitable for nasal delivery in terms of pH, droplet size, and osmolality. Moreover, no protein agglomeration was observed in the two formulations prepared and after spraying with the Aptar VP3 pump, indicating favorable results in applying this system for the delivery of antibodies to the nose. The next step of the development will be the assessment of the stability under refrigerated and ambient storage conditions of the combination product and of the antibody comprised in the formulation. Moreover, in vivo animal studies will allow determining the pharmacokinetics and pharmacodynamics of these two formulations.
