Injecting high-volume, high-viscosity drugs

The era of biologics has opened up avenues for what we call personalized medicine: very specific molecules targeting the diseases right at their core. Due to their effectiveness, biologics and biosimilars are expected to grow at an annual rate of over 8%. We now see several disease areas, historically dominated by a few blockbusters, splitting up in a number of different sub-diseases.

At first this may look like a huge win-win scenario, but it comes with a number of challenges. As patient groups get smaller, the return of investment needs to be covered by higher prices and/or decreased R&D costs. At the same time, patient convenience is in focus and self-treatment is the gold standard in subcutaneous injections. There is also a strong trend toward less frequent administration, and as a result, increasingly large dosing.

With proteins delivered via auto injection subcutaneously in higher doses, there is the major consideration of time. Auto injection time of 10-15 seconds has historically been regarded as the maximum threshold for acceptability – patients typically prefer to not hold a device in place for any longer.

The complex molecular structure of biologics also poses a technical challenge. Biologics have a higher potential for destabilizing or aggregating in the pre-filled syringe or other primary package over the course of its shelf life. They often need to be delivered in higher concentrations to have an effect, and at high concentrations, the viscosity of the product increases exponentially. From a formulation point of view, higher viscosities could cause problems with the drug’s syringeability, which is the ease with which the formulation can be pushed through a needle. At the patient level, the force and needle bore size needed to administer a viscous injection may result in increased discomfort and user anxiety.

Maggie^® is a cartridge-based solution built with SHL’s market-proven Needle Isolation Technology (NIT^®).

Leveraging two decades of experience, SHL’s technologies are able to deliver any formulations for subcutaneous and intramuscular injections effectively and efficiently. Our most requested specifications are available in preconfigured devices that offer a faster developmental timeline compared to bespoke products, giving clients a much shorter path to market with their innovative and novel therapies.

For drug formulations in higher volumes, SHL’s cartridge-based auto injector Maggie^® offers the safe and effective delivery of up to 3.0 mL. Featuring a permanently hidden needle and continuous clicking injection feedback, this easy-to-use two-step auto injector raises the bar for safety.

Cartridges provide a broad range of options for fulfilling various drug characteristics and therapeutic needs, widening the scope of container choices, including for both single and dual-chamber therapy solutions. However, because their needles are not pre-attached, they do pose the risk of contamination and needlestick injuries. SHL addresses this problem with Needle Isolation Technology (NIT^®), a unique safety solution where the needle is pre-installed in the device. In one simple step, the user initiates the automatic needle attachment process without being exposed to the needle. With this technology, SHL ensures that the needle is permanently hidden throughout the entire process, mitigating the risk of metal contamination.

The Molly^® family of devices (from left to right): Molly 1.0 mL FNS, Molly 1.0 mL RNS and Molly 2.25 mL.

SHL’s Molly^® family of auto injectors also offers dosing in higher volumes. Molly^® 2.25, the highest volume variant, features the same intuitive features, ergonomic cap and automatically locking needle cover features of its predecessors. Built with a unique power pack, the Molly^® family offers customization flexibility while enabling pharmaceutical companies to dramatically reduce their investment and timelines.

For higher viscosity drug preparations, SHL’s Bertha^® is a versatile auto injector that can accommodate a 1.0 mL or 2.25 mL pre-filled syringe and liquid viscosities of up to 60 centipoise. For viscosities of up to hundreds of centipoise, SHL’s market-proven Rotaject^® technology offers safe and dependable support. Rotaject^® technology can solve some of the most daunting challenges of biologics with its clock-spring technology that ensures the full dose is pushed by a constant force. This technology allows for high viscosity drugs to be delivered safely and comfortably, within seconds.

All of SHL’s offerings are developed in close partnership with biopharmaceutical clients to increase the patient’s acceptance of the device and ensure patient safety throughout the injection process. Our in-house design team works with clients to develop devices based on human factors studies and input from a range of experts and stakeholders on how the patient understands the device.

SHL is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery devices such as auto injectors and pen injectors. With locations in Taiwan, Sweden and the US, our experienced engineers and designers develop product enhancements and breakthrough drug delivery solutions for pharma and biotech clients globally.