To serve the needs of the pharmaceutical industry and users, Terumo and Nemera agreed to cooperate to confirm compatibility between PLAJEX™ COP prefillable syringes and the Safe’n’Sound® platform, an add-on passive sharps injury protection device for prefilled syringes (PFS).
In an exciting new era in drug development, the uptake of biopharmaceuticals drives more attention to the development of advanced drug delivery devices. Terumo and Nemera have taken benefit of their polymer science know-how to collaborate and provide the pharma industry with a unique combination of PLAJEX™ polymer-based PFS with Safe’n’Sound®.
PLAJEX™ is a sterile ready-to-fill COP syringe developed by Terumo with a strong focus towards biotherapeutic applications. Key features of PLAJEX™ include:
– a silicone oil-free prefilled syringe system, integrating Terumo’s proprietary i-coating™ plunger stopper;
– steam sterilized for mitigating protein oxidation and aggregation;
– selected materials to minimize interactions with the drug product;
– high transparency and resistance to breakage;
– narrow dimensional tolerance of the moulded parts.
Safe’n’Sound® is a customizable platform of add-on passive sharps injury protection devices for PFS developed by Nemera. Amidst the key benefits, Safe’n’Sound® offers biopharmaceuticals with:
– a passive device requiring no extra gesture from the user compared to a naked syringe;
– strong resistance to shocks and vibrations for a robust and reliable functionality;
– good visibility of the tip for easy inspection of the formulation even with low filling volume;
– ergonomic features for ease of use.
To establish and confirm compatibility between PLAJEX™ and Safe’n’Sound®, Terumo and Nemera defined a development plan. The performance of this combination has been verified technically through a Design Verification Plan and validated by users through simulated clinical user studies.
Preparations are ready for commercial supply: pharmaceutical clients are discussing several projects and plan to launch their drug product into the international market with the PLAJEX™ and Safe’n’Sound® injection system.