Terumo and Nemera announce validated compatibility between PLAJEX polymer prefillable syringes and Safe’n’Sound

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. Patient non-compliance with their drug could result in non-effective therapy or even dangerous consequences for potent drugs.

Safe’n’Sound is a customisable 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 with 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.

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 sterilised for mitigating protein oxidation and aggregation;
• selected materials to minimise 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 PLAJEX, 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.

About Nemera:

Nemera is a world leader in the design, development and manufacturing of drug delivery solutions. To know more please visit: please visit: www.nemera.net

About Terumo:

Tokyo-based Terumo  Corporation is one of the world's leading medical device manufacturer develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine. To know more, please visit: www.terumo.com