Our research groups at UGent-VIB have established the VHH-Fc antibody format in an integrated drug discovery-development-manufacturing technology to rapidly respond to respiratory viruses with pandemic potential, in particular to betacoronaviridae such as SARS-CoV-2, and influenza A viruses. This technology has been pressure-tested during the present SARS-CoV-2 pandemic to yield a clinical lead candidate in 2 month’s time1 (paper in press in Cell). This molecule is now under expedited cGMP manufacturing for first-inhuman clinical testing in time for an expected second wave of the pandemic later in 2020, as an intravenous drug to treat hospitalized patients. In this project, we aim to investigate whether nebulization can be used for needle-free dosesparing delivery of our robust anti-SARS-CoV-2 VHH-Fc antibodies. We will investigate drug substance stability under prototyped inhalable drug product generation and simulated administration, and explore preclinical efficacy of inhaled immunotherapy in the now established human ACE2 transgenic mouse model of SARS-CoV-2 viremia.