SYMBIOZE®: LARGE-VOLUMEON-BODY INJECTOR PLATFORMFOSTERING PATIENTS’ EXPERIENCE

Cécile Gross and Mark Tunkel discuss the how Nemera‘s on-body injector platform – Symbioze^® – has been developed by drawing on a combination of lessons learned from the history of injection devices and the company’s extensive experience developing drug delivery devices for the parenteral route.

When considering the delivery of injectables since the first human insulin injection more than 100 years ago, it is clear that the journey from then until now has been paved with many discoveries and improvements – especially when it comes to lessening the burden of disease on patients. From a drug perspective, many developments have led to an increase in the number of pathologies treated via this route, including rare diseases, and an expansion in the therapeutic areas addressed by to the rise of biologics. From a delivery device perspective as well, evolutions have been steady, much to the benefit of patients.

FROM GLASS SYRINGES TO PATCH PUMPS

Returning to the insulin example, bulky reusable glass syringes were replaced by thin disposable plastic syringes with the primary benefit being a reduction in the needle thickness, which translated into less pain for patients during their multiple daily injections. Even if, from a cost perspective, a prefilled syringe or the combination of syringe and vial were – and still are – attractive, administering an accurate dose, carrying the device and, above all, dealing with the psychological aspects of coping with disease remained problematic.

The arrival of pen injectors in the 1980s enabled patients to overcome these factors. Dose accuracy was improved, followed by clinical outcomes and, ultimately, patients’ adherence and acceptance. With regard to reducing the pain, pen injectors only require a low injection force to administer the dose thanks to their very thin single-use needles. Needle phobia is also more easily avoided with this type of needle compared with standard syringe needles.

Another positive aspect is the flexibility offered to patients – there is a variety of choices between reusable and disposable devices, between colours and shapes for younger patients, and between connected devices or standalone ones. When connectivity is desired, the technical solution selected to enable it becomes part of the patient’s continuous glucose management routine, often increasing compliance overall. Finally, the pen shape is discrete and easy to carry, helping with the aforementioned psychological aspects of the disease.

The next jump occurred in the 1990s with insulin pumps for continuous delivery, which have become small, compact, handy and effective. Connectivity offers the possibility to “close the loop” for blood glucose monitoring. Needless to say, managing such a pump requires training, involvement and financial capability on the part of the patient, but it definitely offers lifestyle flexibility without compromising reliability in dose delivery.

Recently, patch pumps seem to have begun replacing infusion sets. These devices are attached to the patient’s skin via an adhesive, which is less invasive than tubing or a catheter. Beyond the commonly expected connectivity features, these pumps are usually equipped with advanced algorithms that enable patients to monitor their condition more closely.

In the same way that solutions provided to patients with Type 1 diabetes later spread to those with Type 2, the evolution in the treatment of diabetes and its comorbidities has led the way for other drugs and therapies. The current developments in injectables are fully benefiting from this evolution. The latest example is on-body delivery systems, which aim to provide bolus delivery of biologics in the fields of immunology, oncology and haematology.

FROM PATCH PUMPS TO ON-BODY INJECTORS: SYMBIOZE^®, AN IDEAL SOLUTION FOR PATIENTS

In order to offer a comprehensive device range for injectables, Nemera has developed Symbioze^® – an on-body injector platform addressing both the challenges of large-volume delivery and sustainability with its reusable-disposable design. Building on the history of injectable pumps discussed here, along with the company’s extensive experience with pen injectors, patient-friendly features are an integral part of the Symbioze^® platform.

Starting with the patch itself, the supplier has been carefully selected for its track record and ability to customise its shape to the device. The shape has been developed with a focus on applying insights gained from the in-house human factors studies conducted by Insight by Nemera. Work is currently in progress to optimise the usability of Symbioze^® by limiting the number of user steps and providing comprehensive instructions for use (IFU), which is expected to increase patient adherence.

As is standard for patch pumps, Symbioze^® has automatic insertion and retraction of the needle, which makes the safety cap a must to avoid needlestick injuries. However, the drug is delivered via a soft cannula, which is reminiscent of the tubing used in older devices and increases patient comfort. There is also an important feature that increases patient safety, whereby the drug is not delivered if the device is not worn properly – this is expected to influence the clinical outcomes to follow a positive curve. This may also avoid high-value drug loss for pharma companies.

Being able to offer a seamless and fluid injection experience encouraged the design team to limit the number of buttons on the interface as well as to manage connectivity and software management remotely from an app or the cloud for the purpose of enhancing the patient’s engagement. To foster patient adherence, the device must not be too complicated to handle, and the guiding instructions must speak by themselves.

One of Nemera’s offerings is connected device UI/UX design. The company has a comprehensive understanding of user needs that informs the development process to determine how to balance development of the device, sensor systems, software and digital platforms to best support the user. Nemera applies this to the development of the device, the mobile application and software development, ensuring that requirements are driven by an understanding of user needs – balancing those with the capabilities of the technology. This design and engineering capability is used to deliver smart solutions that make a real difference to patients’ lives, including in combination with Symbioze^®.

Although sterility and contamination are not an issue in other injection devices, they become a consideration for Symbioze because of its reusability. How can the sterility barrier be ensured when assembling two separate parts? The design team had to overcome this challenge to avoid the manipulation of the primary drug container – a large-volume glass cartridge – by patients. The choice not to have the naked cartridge separated from its housing has been driven by Nemera’s wealth of experience in safety systems for prefilled syringes. Many of its pharma partners are offering high-value drugs in this format, so it is critical for self-injecting patients not to have to worry about correctly positioning the drug container.

Preserving the drug and its container has been a priority during the early phases of the platform development. Nemera’s solution was to add a membrane at the crimping place to control the fluid path opening. This solution has been validated through a series of tests, some of which were conducted with the help of the Hôpitaux Civils de Lyon (France), Lyon’s biggest public hospital network.

Overall, Symbioze^® is a pure combination of the lessons learned from the history of injectable delivery devices and Nemera’s experience developing combination products. It is also an ideal representative of Nemera’s motto: “We put patients first”.

To read the full article: Wearables-ONdD-Sep-2024-Issue-164-MedRes 164_2024_Sep_Wearables_Nemera
To read the full magazine: Wearables-ONdD-Sep-2024-Issue-164-MedRes

About Nemera

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 fulfil our mission.