Stable by Design A New Particle-Formation Method That Preserves Drug Activity Without Refrigeration

A US pharmaceutical technology company has patented a versatile particle-formation process that converts therapeutic and diagnostic agents into stable solid particles – without damaging the agents in the process. The method produces particles that can be stored for extended periods without refrigeration, opening new possibilities for drug formulation, cold-chain-free distribution and next-generation pharmaceutical delivery systems.

The Problem

Many modern therapeutic agents – from biologics and enzymes to diagnostic compounds – are inherently fragile. They are typically formulated as liquid solutions, which can degrade over time, require strict temperature control during storage and transport as part of the cold chain, and may have unfavourable properties such as high viscosity at the concentrations needed for therapeutic doses.

Formulating these agents as solid particles offers theoretical advantages: greater stability, longer shelf life, easier handling and the potential to remove the requirement for refrigeration entirely. However, the challenge is doing so without destroying the agent’s structure or activity in the process. Many existing methods for forming drug-loaded particles – such as spray drying, freeze-drying or precipitation – involve conditions (heat, extreme pH, organic solvents, mechanical shear) that can denature proteins or damage sensitive molecules.

High-concentration formulations are particularly challenging. Administering high doses of a therapeutic often requires solutions of 100 mg/mL or more, which can be viscous, unstable and difficult to handle. Particles offer a way around these problems – but only if they can be reliably made with consistent properties and without compromising the agent they contain.

What This Invention Does

Halozyme Hypercon’s invention describes a method of forming particles by creating droplets of a liquid containing the agent, then contacting those droplets with a second liquid and allowing them to dry – causing the droplets to solidify into particles around the agent. The process is designed to be gentle enough not to significantly alter the structure or activity of the enclosed agent, while still producing particles with controlled and consistent properties.

The resulting particles can be used in a wide range of pharmaceutical formats, including injectable suspensions, inhalable powders, injectable powders, creams, topical pastes and nutraceuticals. Crucially, the process does not require refrigeration for storage, and the particles retain their activity for long periods – addressing the cold chain challenges that complicate the distribution of many modern pharmaceuticals, particularly in resource-limited settings.

The method covers not just therapeutic agents but also diagnostic agents and other materials such as metals, metal salts, polymers and silica – giving the invention scope well beyond pharmaceutical applications.

Key Features

Gentle encapsulation process. The droplet-based formation method avoids the harsh conditions (heat, organic solvents, extreme pH) used in many conventional particle-making processes, preserving the structural integrity and biological activity of the enclosed agent.

Room-temperature stability. Particles produced by this method retain their activity for extended storage periods without refrigeration – a major advantage for distribution to remote areas, emergency stockpiling or regions with unreliable cold chain infrastructure.

Broad agent compatibility. The method works with therapeutic agents, diagnostic agents, metals, polymers, silica and other materials, making it applicable across pharmaceuticals, diagnostics and materials science.

Multiple dosage form outputs. Particles can be used directly in injectable suspensions, inhalable dry powders, injectable powders, topical formulations and nutraceuticals – giving formulators broad flexibility in how they present the final product.

High-concentration enablement. By converting high-concentration solutions into particle form, the method sidesteps the viscosity and instability challenges that make high-dose liquid formulations difficult to manufacture and administer.

Who Is Behind It?

HALOZYME HYPERCON, INC. is a subsidiary of Halozyme Therapeutics, a US biopharmaceutical company known for its ENHANZE drug delivery technology. This application is a divisional of AU 2025210802, which itself originates from an international PCT application (PCT/US2018/043774) corresponding to US national application published as WO 2019/023392. The inventors are Chase Coffman, Lyndon Charles, Paul Brown, Daniel Benjamin Dadon, Lisa Liu, Cory Robinson and Dale Arlington Thomas III. The application is managed by James & Wells Intellectual Property in Canberra.

Why It Matters

The global pharmaceutical supply chain faces enormous pressure from cold chain requirements. Vaccines, biologics and other temperature-sensitive medicines can degrade if even briefly exposed to temperatures outside their storage range, leading to wastage, supply disruptions and patient harm. The COVID-19 pandemic brought these vulnerabilities into sharp relief, particularly in lower-income countries with limited refrigeration infrastructure.

A reliable particle-formation process that removes the need for refrigeration while preserving drug activity could have profound implications for global health equity – making life-saving medicines accessible in settings where cold chains are unreliable or prohibitively expensive. With IPC classifications spanning foam and particle manufacture (C08J 9/28) and granulation technology (B01J 2/06, B01J 2/08, B01J 2/16, B01J 2/30), the invention bridges pharmaceutical science and industrial chemistry in a way that could benefit patients and health systems worldwide.

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AU 2026201513 was published in the Australian Official Journal of Patents on 19 March 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.

Related Concepts

Freeze drying and spray drying are the most widely used methods for converting liquid drug formulations into stable solid forms, but both impose physical or thermal stresses that can compromise fragile biologics. Maintaining product integrity throughout the cold chain remains one of the most costly and logistically demanding challenges in global pharmaceutical distribution, particularly for vaccines and protein therapeutics reaching remote or low-income regions.