Company insight

New-generation biologics to rethink drug delivery

Owen Mumford Pharmaceutical Services (OMPS) is a global industry leader in medical device design and manufacturing. George I’ons, head of product strategy and insights at OMPS, discusses how UniSafe 2.25 – a safety device designed for use with 2.25mL pre-filled syringes – rethinks drug delivery device designs.

administration is picking up pace alongside the trend of self-administration. The marriage of subcutaneous administration and self-administration can help ease some of the weight on healthcare services by helping patients manage their own medication regime, and freeing up time and resources in hospitals and clinics. At the same time, with so many biologics reaching patent expiry, space is being made for manufacturers to market biosimilar products with potential for new routes and methods of delivery to help differentiate them in the marketplace. These combined factors have led to an increasing number of intravenous drugs being redesigned for subcutaneous administration. This comes with a need and opportunity to modify drug delivery devices so they can cope with larger dose volumes and higher viscosity formulations, typical of some newer biologics entering the market.

A High-viscosity drugs

The challenge presented by some new generation biologics and the high-viscosity, high-volume nature of their formulation is three-fold. Firstly, drugs with high viscosity formulations can be difficult to administer while keeping injection force below the recommended maximum value of 10N. Injection time must be prolonged, yet data shows that holding the device for any longer than ten to 15 seconds to inject medication may prove challenging for patients. If the device is removed too early, the full dose may not be injected and there could be a risk of ‘wet injections’ and drug wastage. Secondly, given that viscosity further increases in low temperatures, pre-filled syringes or other injection devices containing biologics have to be removed from refrigeration and allowed to reach room

s there continues to be significant advances in biological drug development, subcutaneous

The newest addition to OMPS’s UniSafe platform, UniSafe 2.25 was adapted to new-generation biologics.

temperature before an injection can be comfortably attempted. Lastly, needle size must be adjusted to facilitate the delivery of these higher viscosity formulations and yet remain comfortable for the patient to use. Smaller gauge needles with a larger diameter can be used, but these may result in more painful injections for patients and could impact their adherence for the treatment regime. For subcutaneous injections, 25–29G is typically an acceptable size range for needles, ideally with thin wall designs. Due to these challenges, high-viscosity formulations risk jeopardising the comfort and ease of administration, calling for new and adapted drug delivery devices that can support new-generation biologics while also upholding patient adherence.

High-volume biologics

Delivery devices with standard pre-filled syringes are designed for formulations up to 1mL, typically with a viscosity under 10cP and may not be suited to delivering new-generation biologic formulations. There are also 2.25mL pre-filled syringes emerging alongside safety devices that can accommodate them. UniSafe 2.25, a new

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addition to OMPS’s UniSafe platform, was designed to address these challenges. Designed for higher volume drugs, it is well adapted to new-generation biologics. Like the 1mL version, UniSafe 2.25 was created with a unique spring-free design and integrates critical safety features. Compliant with sharps safety regulations, patients using UniSafe 2.25 are protected from needlestick injury after injection, thanks to the passive deployment of the needle-shielding safety mechanism. Once complete and the plunger fully depressed, the needle retracts into the safety shroud. Its design features a large comfortable integrated plunger head and finger flange design for easy operation, even for patients with lower dexterity or strength. At the rear of the device, the syringe plunger is non-removable, which helps to prevent leakages, ensure the full dosage is administered and protect the product from tampering. UniSafe 2.25 can be used with both small round flange and cropped flange 2.25mL pre-filled syringes (ISO standard designs), making it compatible with a wide range of primary containers and suppliers. ● 15

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