Nemera and Terumo announce validated compatibility between PLAJEXTM polymer prefillable syringes and Safe’n’Sound®January 26, 2017
To serve the needs of the pharmaceutical industry and users, Terumo and Nemera 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®.
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.
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 PLAJEXTM 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.
For further information, please refer to the whitepaper published in ONdrugDelivery – Prefilled syringe focus, edition N° 73, February 2017.
Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its expertise covers all five modes of delivery: Nasal/Buccal/Auricular (spray pumps, actuators, valves, etc.), Ophthalmic (preservative-free multidose eyedroppers), Pulmonary (pMDI, MDI’s, DPI’s), Dermal /Transdermal (airless & atmospheric dispensers), and Parenteral (autoinjectors, pens, and safety devices).
Nemera provides solutions for the pharmaceutical industry, including standard innovative products, the development of proprietary devices and contract manufacturing.
Find Terumo on the web at www.terumo.com
Tokyo-based Terumo Corporation is one of the world’s leading medical device manufacturers with over US$5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation’s shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan’s leading stock index.