Device and formulation considerations for nebulized biologics

Delivering biologics to the lungs presents challenges related to maintaining stability and potency during nebulization. The choice of nebulization device—whether air jet, ultrasonic, vibrating mesh or soft mist—greatly influences the preservation of biologic integrity, with each technology offering distinct benefits and limitations. Formulation strategies, including the use of surfactants, stabilizers and optimized nebulizers, are crucial for mitigating degradation during aerosolization.

Increasingly, inhaled biotherapeutics are being utilized to treat a wide array of diseases, leveraging the unique advantages of pulmonary delivery. Overall, the ability to minimize stresses on aerosolized formulations of biologics is of utmost importance. This article will consider device and formulation approaches for inhaled biologics and conclude with a case study that investigates the influence of nebulization on polyA-loaded lipid nanoparticle (LNP) integrity. Evaluating nebulization of lipid nanoparticle-encapsulated nucleic acids underscores the need for continued innovation in both formulation and delivery technologies. The authors believe that moving forward, refining these approaches will be essential to fully realize the potential of inhaled biotherapeutics for a broader range of conditions.