Pharma Trio to Debut At-Home, High-Dose Drug Delivery Platform

PARIS, FRANCE – January 16, 2026 – A new strategic collaboration between three pharmaceutical technology leaders aims to shift the administration of complex, high-dose biologic drugs from the clinic to the comfort of a patient’s home. Datwyler, LTS Device Technologies, and Stevanato Group announced they have joined forces to create an integrated platform for large-volume subcutaneous drug delivery, a move poised to accelerate the market entry of next-generation therapies.

The partnership combines expertise in elastomer components, wearable devices, and drug containment to address a pressing need in modern medicine: the convenient self-administration of treatments like monoclonal antibodies and anti-cancer drugs, which often require volumes too large for traditional injection methods. The companies are set to unveil their pre-verified platform solution at the upcoming Pharmapack conference in Paris on January 21-22, 2026.

A Revolution in Patient-Centric Healthcare

The announcement comes amid a profound transformation in the pharmaceutical landscape, driven by two converging trends: the explosive growth of biologic therapies and a strong patient preference for decentralized healthcare. Biologics, which are complex medicines derived from living organisms, represent the cutting edge of treatment for many chronic and life-threatening diseases. According to Precedence Research, the U.S. biologics market is on a steep upward trajectory, projected to reach an estimated $483 billion by 2034.

However, these powerful therapies, particularly monoclonal antibodies used in oncology and autoimmune treatments, often require high-dose formulations that challenge conventional delivery methods. Simultaneously, patients are increasingly seeking more control and convenience in their treatment regimens. A recent Mayo Clinic study highlighted this shift, finding that 73% of participants preferred in-home self-administration after 24 weeks of therapy. This desire to avoid frequent, time-consuming trips to hospitals or infusion centers underscores the demand for solutions that empower patients.

"By enabling patients to self-administer therapies at home, subcutaneous drug administration facilitates a growing shift towards more accessible personalized healthcare," said Paolo Ferrigno, Product Manager at Datwyler, in the official announcement. He noted that the components his company provides, such as the spray-coated NeoFlex™ plungers, are designed to "increase the functional reliability of large volume injection systems and promote greater comfort and safety for the patients."

Overcoming the 2mL Subcutaneous Barrier

For decades, subcutaneous injections—those delivered into the tissue just beneath the skin—have been largely limited to volumes of 2mL or less. This constraint is due to physiological challenges, including potential pain, tissue tolerability issues, and the kinetics of drug absorption. While effective for many medicines, this volume cap presents a significant hurdle for the new wave of high-dose biologics.

Transitioning these large-volume therapies from controlled, intravenous hospital infusions to at-home subcutaneous delivery requires overcoming these technical and physiological barriers. The design of a custom delivery solution for each new drug is a time-consuming and costly process for pharmaceutical manufacturers, creating a bottleneck in a highly competitive market.

"There is a pressing market need for innovative solutions to support larger volumes of up to 20mL in a self-administered setting while strictly maintaining safety, therapeutic efficacy, and patient compliance," commented Riccardo Marcon, Senior Vice President of Sales & Marketing of Drug Containment Solutions with Stevanato Group. He emphasized that ready-to-use components are critical for efficiency, stating, "Our market-leading ready-to-use, EZ-fill® containers are supplied pre-washed, pre-siliconized, pre-assembled with front stoppers, packed in Nest & Tub and pre-sterilized."

An Ecosystem for Accelerated Innovation

The collaboration between Datwyler, Stevanato Group, and LTS Device Technologies is built on the concept of a pre-verified "ecosystem." By integrating their respective best-in-class technologies into a single platform, they offer pharmaceutical partners a streamlined path to market, reducing development timelines and de-risking the manufacturing process.

The platform consists of three synergistic components:
* Stevanato Group's EZ-fill® Cartridges: These large-volume, ready-to-use glass cartridges serve as the primary drug container. By providing them pre-sterilized and ready for filling, Stevanato Group helps pharmaceutical companies bypass several complex and capital-intensive manufacturing steps, accelerating production.
* Datwyler's NeoFlex™ Plungers: These critical elastomer components are engineered for large-volume containers. Their proprietary fluoropolymer spray coating provides a complete barrier that prevents drug interaction and ensures smooth, controlled gliding without the need for silicone oil, which is vital for maintaining the integrity of sensitive biologics.
* LTS Device Technologies' Sorrel™ Platform: This wearable, on-body injector is the patient-facing part of the solution. The smart device is designed to be pre-filled and pre-loaded, simplifying use for patients at home. Its software-controlled electromechanical pumping system allows for the precise, slow, and comfortable delivery of drug volumes up to 20mL from the cartridge.

This integrated approach aims to provide a reliable, off-the-shelf solution that addresses the entire delivery chain, from sterile containment to patient-friendly administration.

Navigating a Competitive and Regulated Future

The alliance enters a dynamic and competitive market for wearable drug delivery devices. Other major players, including Enable Injections, BD, and Ypsomed, are also developing advanced on-body injectors to meet the demand for at-home biologic administration. The key differentiator for the Datwyler-LTS-Stevanato partnership appears to be its focus on a fully integrated, pre-verified system that promises to reduce complexity and speed up development for drug manufacturers.

However, bringing such a combination product—one that integrates a drug and a device—to market involves navigating a complex regulatory landscape. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent requirements for these products, demanding extensive data on device performance, drug stability, and human factors. Proving that patients can use the device safely and effectively without direct medical supervision is a critical step in the approval process.

The success of this new platform will ultimately depend not only on its technical performance and regulatory approval but also on gaining the trust of both clinicians and patients. The collaboration's emphasis on a patient-centric design, combined with the established reliability of its component parts, signals a clear strategy to address these challenges and secure a leading position in the future of large-volume drug delivery. The upcoming presentation at Pharmapack is expected to provide further details on the system's capabilities and the roadmap for its adoption by the pharmaceutical industry.