Datwyler Collabs with Stevanato and LTS to Advance Home-based Biologics

Datwyler, LTS Device Technologies, and Stevanato Group have announced a strategic collaboration aimed at expanding the capabilities of large-volume subcutaneous drug delivery and enabling convenient on-body administration of higher-dose therapies, according to a Datwyler press release (1). The companies plan to unveil their integrated platform solution at the Pharmapack Europe conference, taking place in Paris Jan. 21–22.

The collaboration comes at a time when the pharmaceutical industry is undergoing a significant shift from small-molecule drugs to complex biologics. As development pipelines increasingly focus on monoclonal antibodies and oncology treatments, manufacturers face growing challenges in delivering sensitive, high-dose therapeutics. Many of these therapies require volumes that exceed the 2 mL limit of conventional subcutaneous injections, driving demand for delivery systems capable of safely and effectively administering volumes of up to 20 mL while maintaining patient comfort, therapeutic efficacy, and regulatory compliance (1).

Drivers behind the shift to large-volume subcutaneous delivery

Clinical requirements and patient expectations are accelerating interest in large-volume subcutaneous administration. As healthcare systems move toward decentralized models of care, patients increasingly favor treatments that can be self-administered outside of clinical settings as evidenced by a Mayo Clinic study. It was found that 73% of patients preferred in-home self-administration after 24 weeks of treatment. The finding underscores a strong preference for convenience and autonomy in long-term therapy management (2).

This trend is reinforced by advances in device and component technologies that make home-based delivery more feasible for high-dose biologics. In a Datwyler press release, Paolo Ferrigno, Product Manager for Datwyler, states that, "by enabling patients to self-administer therapies at home, subcutaneous drug administration facilitates a growing shift towards more accessible personalized healthcare. Datwyler’s spray coated NeoFlex™ plungers increase the functional reliability of large volume injection systems and promote greater comfort and safety for the patients” (1). Such component-level innovations are critical for addressing the mechanical and functional demands associated with higher injection volumes.

In spite of growing demand, the transition to large-volume subcutaneous delivery has historically been constrained by technical challenges, including managing absorption kinetics, ensuring tissue tolerability, and designing delivery systems capable of controlled administration without compromising patient experience according to Datwyler. Developing bespoke solutions to address these variables can be resource-intensive and difficult to align with the compressed timelines of competitive drug development programs. As a result, manufacturers are increasingly seeking standardized, pre-verified platform solutions that reduce development risk and accelerate time to market.

The role of pre-verified platforms in streamlining development

The partnership brings together complementary expertise in elastomer components, drug containment systems, and wearable delivery devices to support cartridges ranging from 10 mL to 20 mL (1). For pharmaceutical companies, the use of ready-to-use, pre-qualified components can significantly reduce the complexity associated with container closure system development and validation.

Riccardo Marcon, SVP of Sales and Marketing of Drug Containment Solutions at Stevanato Group, emphasizes the importance of integrated solutions, stating in the press release, "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. For pharma companies, EZ-fill® Large Volume Cartridges have been the ideal solution to reduce their complex operations for more than a decade. 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” (1).

The collaboration leverages Stevanato Group’s ready-to-use large-volume cartridges in combination with Datwyler’s NeoFlex™ plungers, which are engineered to support the slow, controlled injection profiles required for high-volume subcutaneous delivery (1). These components are integrated with the Sorrel wearable delivery platform from LTS Device Technologies, enabling on-body administration that aligns with patient preferences for discreet, home-based treatment.

The significance of this collaboration lies in its potential to reduce development timelines, de-risk regulatory pathways, and support scalable commercialization of large-volume biologics. By offering a pre-verified, end-to-end platform, the three companies aim to address persistent technical barriers while aligning with market demands for patient-centric delivery models.

The technical and strategic rationale behind the partnership will be explored in greater detail during a Learning Lab session titled "When Size Matters: The Evolution of Self-Delivery Solutions for Subcutaneous Administration," presented by experts from all three companies at Pharmapack Europe. Attendees will have the opportunity to engage directly with the collaborators to discuss end-to-end support for large-volume drug delivery programs and the implications for future biologics development.

References:

1. Datwyler. Datwyler, LTS Device Technologies, and Stevanato Group Collaborate to Expand Self-Delivery Options for Large-Volume Drugs. Press Release. Jan 20, 2026
2. Mayo Clinic. Is home-based treatment the future of cancer care?. Study. Jan 16, 2026