BREAKTHROUGH FOR LARGE-VOLUME MANUAL INJECTION: A FIRST-OF-ITS-KIND LARGE-VOLUME PFS IN A PASSIVE SAFETY SYSTEM

Isabelle Jeangoudoux and Léa Salfati introduce the industry’s first fully integrated large-volume passive safety system, combining the syriQ BioPure® 5.5 mL prefillable glass syringe with the Safe’n’Sound® 5.5 mL passive safety system. The authors explain how joint development, compatibility testing and human factors research are de-risking large-volume subcutaneous self-injection at home.

Subcutaneous (SC) drug delivery continues to expand as an alternative to intravenous infusion, supporting the broader shift towards decentralised, patient-centric care. This shift is accompanied by a growing focus on large-volume biologics, with an increasing number of therapies requiring dose volumes beyond the 1–2.25 mL range historically associated with prefillable syringes (PFSs). To meet this need safely and conveniently at home, SCHOTT Pharma and Nemera have worked together to design the first large-volume passive safety system supporting manual self-injection at home: Nemera’s Safe’n’Sound® 5.5 mL passive safety system built specifically around SCHOTT Pharma’s syriQ BioPure® 5.5 mL staked-needle glass PFS – the first large-volume staked-needle glass PFS on the market.

The syriQ BioPure 5.5 mL PFS was the first-of-its-kind to be verified for at-home use with an autoinjector. There was an unmet need, however, for a 5.5 mL PFS combined with a passive safety system for manual injection. Manual injection devices may be preferred by some users because they retain the familiarity and simplicity of a PFS. Manual injections can also provide greater control over the injection experience, including injection speed and visual confirmation of dose delivery. Furthermore, manual devices can be more economical to produce due to the lower complexity of the subassembly, which may be important for some patient groups and geographic regions. Pharmaceutical companies may choose to launch a formulation in both an autoinjector and a manual injection device to cover a broader range of markets.

Requirements for the Safe’n’Sound 5.5 mL system were shaped through direct dialogue with pharmaceutical customers, and the development builds on the established platform compatibility already proven between SCHOTT Pharma and Nemera with 1 and 2.25 mL formats. The result is a large-volume drug delivery solution that offers flexibility of grip posture and strong commercial attractiveness – capabilities that current large-volume delivery options on the market cannot fully match – while making at-home self-injection of biologics accessible to a much larger pipeline of drug formulations. To support this development, SCHOTT Pharma and Nemera have run a structured programme of mechanical, performance and human factors testing.

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