Addressing challenging formulations: Reunite to support lyophilized drug delivery

At the 2025 PDA Universe of Pre-Filled Syringes and Injection Devices Conference, SHL Medical’s Seda Aksel, PhD, and Lyophilization Technologies Inc. (LTI)’s Michael Thomas, PhD took the podium to address one of the most pressing challenges in pharmaceutical development today: the delivery of lyophilized formulations.  

The joint presentation, titled “Addressing challenging formulations: A novel drug delivery system supporting the automated reconstitution and delivery of lyophilized solutions,” highlighted how innovation in device and process can converge to unlock new possibilities for biologics and other unstable formulations. 

Lyophilization in modern drug delivery 

Many biologics and sensitive molecules simply cannot remain stable in liquid form for long, limiting their shelf life and global distribution potential. Lyophilization, or freeze-drying, has become a key solution, offering enhanced drug stability and preserving biological activity over time. Yet while lyophilization stabilizes the formulation, it simultaneously introduces complexity to the preparation process.  

The current standard, vial kits, typically involves multiple components and preparation steps that demand both technical skill and careful handling, often under the guidance of a healthcare professional. These requirements add cost, increase the risk of contamination, and make consistent dosing more difficult to achieve. 

The presentation explored how dual-chamber delivery systems address these challenges. By integrating the drug and diluent within a single device, such systems simplify preparation, reduce handling risks, and help ensure consistent dosing. Despite these advancements, there remains room for improvement, particularly in usability, patient independence, and dosing accuracy. 

It was against this backdrop that SHL Medical introduced Reunite, a dual-chamber cartridge-based autoinjector that supports automated reconstitution and delivery of lyophilized drugs. With just three simple user actions: Unlock, Twist, and Push, Reunite combines the stability advantages of lyophilization with the precision and ease of a standard autoinjector, paving the way for lyophilized drug delivery at home. 

Insights from Lyophilization Technology Inc. 

The session then transitioned to the manufacturing vantage. Michael Thomas of LTI, an Alliance partner, guided the audience through the fill-and-finish process of lyophilized formulations. He highlighted how LTI is optimizing the process by using a magazine holder that creates ideal freezing profiles. The session concluded with insights into the broader economic and market benefits: as the adoption of lyophilized therapies increases, the cost advantages of reduced cold-chain dependency and minimized drug overfill become even more significant. 

An engaging Q&A followed, during which attendees discussed how dual-chamber cartridges influence device development requirements and examined the usability advantages of Reunite, not only compared to traditional vial kits, but also with dual-chamber pre-filled syringes. Another topic of interest was how customizable cannula configurations can accommodate formulations with varying viscosities. SHL Medical’s market proven Needle Isolation Technology (NIT®) emerged as an established solution, offering full control over cannula gauge and length to achieve the desired injection time and depth. 

The future of lyophilized drug delivery 

The underlying message in Vienna was clear: the convergence of formulation science and device innovation is becoming more critical than ever. Solutions such as Reunite demonstrate how the next generation of lyophilization and reconstitution systems can combine scientific rigor with user-centric design. The future of lyophilized drug delivery lies in devices that ease patient burden, enhance accuracy, and support patient independence, while enabling manufacturers to achieve more efficient fill-finish processes, lower logistical costs, and wider global reach.  

For those who missed the presentation and would like to explore further, SHL Medical welcomes you to contact the team to request the full slide deck.