A high quality and robust safety system for high-volume biologics at home
Audrey Chandra and Cécile Gross discuss Nemera’s development of a new product for the safe delivery of high-volume biologics at home.
Needles have been used to inject drug treatments for a long time, via intradermal, subcutaneous or intramuscular routes. Thanks to prefilled syringes (PFSs), a number of new drugs are now being administered in medical settings. These include different types of molecules – for example, anti-thrombotic agents, such as heparin. Vaccines and other small molecules are also commonly administered subcutaneously (SC) by healthcare professionals. However, recent developments in drug research and production have made available bigger molecules. Biological drugs have become available in PFSs and are predominantly used to treat complex chronic conditions.
The trend towards self-administration comes from two directions at the same time: from pharmaceutical companies that offer these biological drugs for chronic conditions in PFSs – and patients themselves.
Safety system for biological self administration
How did Nemera enter this market? It first offered a safety system with a Luer lock, but the availability of PFSs with a staked needle has made it possible to offer the first Safe’n’Sound® in 1 mL. Compatible with several kinds of glass PFS following ISO standards, it is also compatible with the PLAJEX® polymer PFS from Terumo.
In order to add the benefits of a platform approach, the device has been conceived as flexible. Available in different kinds of flange types, it can offer customisation with “soft-touch” material to improve grip, as well as an overcap to ease the rigid needle shield removal. Colour customisation for a safer drug or dose identification is also available.
SAFE’N’SOUND® 2.25 ML: A CUSTOMISABLE PLATFORM
Biological drugs are very often needed in high concentration. This can be driven by the nature of the molecule, the composition of the final drug and the effort to decrease the frequency of treatment for the patient. Their viscosity increases according to the power law of the antibody concentration. Thus, to be injected, these molecules need to be diluted, which leads to higher injection volumes and lower (but still high) viscosity. As a result, larger-dose drug deliveries are a growing segment, with volume shifting towards 2 mL.
Taking this market need into account and leveraging its experience with the 1 mL version, Nemera developed a 2.25 mL device, safeguarding the device robustness as well as the platform approach.
To read the full article : HERE
As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.
For more information, visit www.nemera.net