To serve the needs of the pharmaceutical industry and users, Nemera and Terumo agreed to cooperate to confirm compatibility between PLAJEXTM 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 PLAJEXTM polymer-based PFS with Safe’n’Sound®. Patient non-compliance with their drug could result in non-effective therapy or even dangerous consequences for potent drugs.
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.
PLAJEXTM is a sterile ready-to-fill COP syringe developed by Terumo with a strong focus towards biotherapeutic applications. Key features of PLAJEXTM include:
? a silicone oil-free prefilled syringe system, integrating Terumo’s proprietary i-coatingTM 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.
To establish and confirm compatibility between Safe’n’Sound® and PLAJEXTM, Nemera and Terumo 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 Safe’n’Sound® and PLAJEX™ injection system.
For further information, please refer to the whitepaper published in ONdrugDelivery – Prefilled syringe focus, edition N° 73, February 2017.