A method and system for room temperature stabilization of pharmaceuticals and biologics through rapid aerosol dehydration

Background

The field of pharmaceutical formulation, particularly for biologics such as vaccines and viral therapeutics, faces significant challenges in preserving the stability and efficacy of sensitive biological materials. Many of these products, including those containing enveloped and nonenveloped viruses, require strict temperature control throughout manufacturing, storage, and distribution—a process known as the cold chain. Maintaining the cold chain is logistically complex, costly, and often unreliable, especially in resource-limited or remote settings. This dependency on refrigeration and freezing not only increases operational expenses but also limits the global accessibility of life-saving drugs and vaccines, highlighting a critical need for technologies that enable room-temperature stability of biologic pharmaceuticals.

Current approaches to stabilizing biologics primarily rely on spray drying and freeze-drying (lyophilization) techniques. However, these methods present significant drawbacks. Spray drying exposes sensitive materials to high temperatures (often 100–200°C), which can denature proteins and inactivate viruses, while freeze-drying requires extremely low temperatures (around –40°C), leading to high energy consumption and long processing times. Both methods often necessitate the addition of excipients or stabilizers to protect the active ingredients, further complicating formulation and regulatory approval. Additionally, conventional atomization techniques produce relatively large and non-uniform droplets, resulting in powders with suboptimal solubility and bioavailability. These limitations underscore the urgent need for alternative solutions that can efficiently produce stable, biologically active powders at room temperature without compromising product quality.

Technology

Rapid Room Temperature Aerosol Dehydration (RTAD) is an advanced technology designed to convert liquid pharmaceutical formulations, including those containing sensitive biological materials such as enveloped and nonenveloped viruses, into stable dry powders at room temperature. The system features a proprietary multi-coaxial nozzle with at least three tubular channels that precisely atomize the liquid into ultra-fine droplets ranging from 0.2 to 20 micrometers. These droplets are introduced into a closed drying chamber, where a controlled stream of gas—such as nitrogen or air—facilitates rapid solvent evaporation at temperatures between 15°C and 35°C. The process is managed by integrated flow controllers and sensors, ensuring consistent gas and liquid delivery. The resulting dry powders, often with median particle sizes below 5 micrometers, are collected via filters or cyclone separators, yielding a product suitable for storage, transport, and a variety of drug delivery applications without the need for refrigeration or high-heat processing.

What differentiates RTAD from conventional drying methods like spray drying and freeze-drying is its ability to operate efficiently at room temperature, thereby avoiding the thermal or cryogenic stress that can compromise the integrity and biological activity of sensitive pharmaceutical ingredients. The proprietary atomization technique produces droplets significantly smaller and more uniform than those generated by traditional nozzles, enabling faster and gentler drying. This not only preserves the infectivity and protein integrity of viruses and other biologics but also enhances the solubility and bioavailability of the final product. RTAD is highly scalable, energy-efficient, and requires fewer excipients, resulting in lower operational costs and superior product quality. Extensive experimental validation has shown that RTAD retains the biological function of both enveloped and nonenveloped viruses, making it a transformative solution for the pharmaceutical, biopharmaceutical, and related industries, especially where cold chain logistics are a challenge.

Benefits

• Enables thermal stabilization of pharmaceutical formulations at room temperature, eliminating the need for refrigeration or freezing.
• Produces ultra-fine, uniform dry powder particles (often below 5 micrometers) that enhance solubility and bioavailability.
• Preserves biological activity and infectivity of both enveloped and nonenveloped virus particles and other sensitive biologics.
• Operates rapidly and continuously with lower energy consumption and reduced operating costs compared to traditional spray drying and freeze-drying.
• Utilizes a proprietary multi-coaxial nozzle for precise atomization and controlled drying, minimizing thermal or cryogenic stress.
• Scalable process suitable for manufacturing therapeutic doses and adaptable to a wide range of biologics, vaccines, proteins, nucleic acids, and small molecule drugs.
• Produces stable powders suitable for storage, transport, and various drug delivery methods without requiring cold chain logistics.
• Reduces or eliminates the need for additional excipients or stress-protecting additives in formulations.

Applications

• Room temperature stable vaccine powders
• Inhalable biologic drug formulations
• Cold chain-free drug transport
• Rapid pandemic vaccine stockpiling
• Stabilized protein or antibody powders

Additional info

Rapid Room Temperature Aerosol Dehydration (RTAD) utilizes multi-coaxial nozzles with three or more channels to atomize liquid formulations into 0.2–20 μm droplets. Within a closed chamber, gas-facilitated solvent evaporation occurs at 15°C–35°C, producing dry powders with median particle sizes below 5 μm. This process encapsulates enveloped and nonenveloped viruses, preserving biological activity without refrigeration. It provides a scalable, energy-efficient alternative to lyophilization, ensuring thermal stability for vaccines and biologics.