SHL Medical’s Reunite is showing that self-administering lyophilised drugs at home is finally within reach.
SHL Medical
As biologics and other complex therapies reshape modern medicine, lyophilisation has become a cornerstone of innovative drug development. By converting unstable formulations into stable powders, this freeze-drying method extends the shelf life of active ingredients while reducing dependence on cold-chain logistics.
However, the complex vial kits conventionally used for lyophilised parenterals have prevented reliable and routine self-administration.
New solutions – most notably the introduction of dual-chamber primary containers and their integration into autoinjectors – are combining reconstitution and injection into a single, controlled sequence. By removing key barriers to administration, these emerging technologies are finally making at-home self-injection a practical and scalable option for lyophilised drugs.
The rise of lyophilisation
Lyophilisation stabilises biologics such as antibodies and peptides by removing water, thereby preventing degradation and enabling storage at room temperature or in less stringent refrigerated conditions.
Regulatory approvals of lyophilised injectables have risen markedly since the early 2000s. Roughly one in three parenterals approved by the US FDA are lyophilised products, and the global market for lyophilised drugs is projected to grow from $371 billion in 2025 to $683 billion by 2032.
Although manufacturing costs for lyophilised products can be higher up front, these are generally outweighed by advantages throughout the product lifecycle.
Most liquid formulations require continuous temperature control – from the factory to the warehouse to the hospital, clinic, or pharmacy. Cold-chain management accounts for nearly 18% of total biopharma logistics costs and poses inventory risks, including losses from temperature excursions. By contrast, lyophilisation minimises cold storage needs, allowing more adaptable distribution with lower long-term expenses and fewer supply-chain vulnerabilities.
The patient delivery barrier
Traditionally, lyophilised drugs have come in vial kits that require manual reconstitution: adding diluent, mixing, then drawing the solution into a syringe. This complex procedure – typically involving 12-15 steps – demands dexterity and sterile handling. The complex delivery sequence is time-consuming, further increasing the risk of user error.
This complexity means most patients require training or support from healthcare professionals, which severely limits the take-up of self-administration. As healthcare shifts towards home-based and self-administered models, such complex procedures for lyophilised drug delivery are unsustainable.
An integrated approach
SHL Medical’s Reunite is overcoming this usability barrier.
Reunite is an easy-to-use dual-chamber cartridge (DCC) autoinjector featuring SHL’s Needle Isolation Technology (NIT) and designed to support automated reconstitution and delivery of lyophilised formulations.
The streamlined delivery process starts with the user unlocking the knob, which triggers an automated reconstitution sequence in which a spring mechanism mixes the diluent with the lyophilised drug. Next, twisting the cap primes the system, with the sterile, pre-attached cannula engaging to establish the fluid path. Finally, the device is pressed against the skin to deliver the injection.
The entire delivery process is thus reduced from 12-15 manual steps to three, supporting self-administration and patient independence.
Reunite was the first autoinjector of its kind approved in the US in 2024 and in the EU, UK, and Switzerland in 2025.
Streamlining processes by partnering with Lyophilization Technology, Inc.
Successfully bringing a lyophilised therapy in an integrated device to market requires tight coordination across formulation development, lyophilisation, fill-finish, and final device assembly. To streamline these efforts, device companies are collaborating with contract development and manufacturing organisations (CDMOs) that specialise in lyo-liquid processes and DCC filling.
SHL’s collaboration with Lyophilization Technology, Inc. exemplifies this approach: aligning device design with proven lyophilisation and filling capabilities reduces technical risk and accelerates development and commercial launch timelines.
The strategic value of Reunite
Reunite advances the potential of lyophilised therapies by combining long-term formulation stability with simplified self-administration and faster commercialisation. Designed as a streamlined three-step system, Reunite reduces training requirements and empowers patients to manage treatment confidently and independently.
The inherent stability of freeze-dried formulations reduces cold-chain dependence and strengthens supply chain resilience. Supported by SHL’s integrated partnerships across lyophilisation and DCC filling processes, such as that with Lyophilization Technologies, Inc., Reunite minimises technical risk, streamlines development, and accelerates time to market.
As investment and research into complex biologics and home-based care models continue to grow, a future is quickly approaching where patients can safely and easily self-administer an increasing number of lyophilised therapies in the comfort of their own home. For pharmaceutical companies, device technologies that automate the reconstitution and delivery of lyophilised formulations – such as Reunite – offer a practical path to making this future a reality.
Together, these advances enable reliable self-injection and enhance patient independence.