Room-Temperature Aerosol Dehydration (RTAD) is an emerging continuous drug product formulation platform that converts liquid biologics and vaccines into shelf-stable, bioactive powders without cold chain dependency. Developed at Princeton University and commercialized by Inaedis, Inc., this scalable cGMP-compatible process gently generates aerosols of sub-20 µm droplets that flash-evaporate at room-temperature conditions — preserving biomaterial potency while eliminating the harmful thermophysical and dehydration stresses inherent to conventional spray drying and lyophilization. From a formulation standpoint, RTAD uniquely bridges enabling thermal stability, controlled release and bioavailability enhancement for biologics. Technology allows precise control over particle morphology, size distribution, and excipient composition to tune drug release profiles and improve the bioavailability of high-molecular-weight therapeutics across multiple delivery routes. RTAD supports diverse therapeutic platforms including proteins, monoclonal antibodies, viral vectors, mRNA-lipid nanoparticles, live-attenuated vaccines, bacteriophages, and subunit formulations. Additionally, RTAD enables ultra-concentrated formulations of biologics, e.g., mAbs with >400 mg/mL, compatible with prefilled syringes and autoinjectors — reducing dose volumes and facilitating multi-antigen delivery with favorable pharmacokinetic profiles. RTAD-produced thermostable powders accommodate versatile delivery systems aligned with the controlled release landscape: subcutaneous administration, inhalation via dry powder inhalers and nebulizers, transdermal administration, and. The continuous, scalable nature of the aerosol dehydration process offers a promising alternative to batch lyophilization, opening new pathways for continuous biopharmaceutical manufacturing of thermostable solid-dose biologics. This formulation platform addresses critical stability and manufacturability challenges across oncology, autoimmune diseases, gene therapy, and vaccination, while expanding therapeutic access through flexible, cold-chain-free delivery strategies that improve patient compliance and enabling equitable global distribution of next-generation biologic therapies.
