The biologics market is expanding rapidly – with a compound annual growth rate of 15% predicted until 2027. But this new generation of drugs comes with unique challenges that require an innovative approach underpinned by extensive experience.
Stevanato Group
That’s why Stevanato Group has developed novel solutions designed to help clients work with complex, sensitive and hard-to-stabilise monoclonal antibodies (mAbs). Its glass drug containment solutions and drug delivery devices are combined with state-of-the-art analytical services, reliable technologies and manufacturing equipment.
One of the key challenges with mAbs is the stability, potency and safety of the drugs over time and the fact that they are more susceptible to drug-container interaction. Reliable delivery systems are crucial to improve therapy adherence, but the higher concentration and injection volume of mAbs can lead to issues with delivery device functionality. Right-first-time development becomes harder than ever.
Stevanato Group’s Technology Excellence Centers (TECs), located in Italy and the USA, provide tailored analytical and device testing services to support clients from early-stage development to launched combination products – reducing risk and improving quality along the way.
A prime example of this is when a leading pharmaceutical company needed a new staked-needle pre-filled syringe (PFS) to be used in a disposable auto-injector for its mAb product and involved Stevanato Group’s TEC team to find a solution. The pharma company had encountered out-of-specification injection times during tests with other syringes on the market. The TEC team analysed the interactions between the drug and the container components and discovered that the thickness of the silicone layer inside the syringe was a contributing factor, as it thinned when in contact with the drug due to the wettability effect, particularly with the use of standard sprayed-on silicone oil. Further tests revealed that the use of Stevanato Group’s Alba® syringes, which have a cross-linked silicone coating, significantly reduced silicone migration – providing a more consistent and durable performance. Because Alba® syringes demonstrated a stable, predictable glide force, they also successfully met the injection time requirements – in this case, less than 15 seconds – over time.
More recently, Stevanato Group’s PFS offering has been extended with the addition of a 8 mm special thin wall (sTW) 27G needle. While maintaining the same external dimensions as a standard thin wall needle and tip design, it features a shorter length and a larger internal diameter. For biologic formulations with higher viscosities, this increases flow rate through the needle and, therefore, reduces the injection force required, enhancing the injection experience for patients.
When it comes to drug delivery devices, the Aidaptus® two-step, single-use auto-injector, developed in collaboration with Owen Mumford, can accommodate a variety of drug viscosities, including mAbs. It can also adapt to different dose volumes with no change parts, while accommodating to 1 and 2.25mL PFSs in the same form factor. For pharmaceutical innovators, this enables Aidaptus® to adapt to the specific characteristics of a novel drug formulation through changes to the specification of the syringe components. And it is compatible with Alba® syringes, which can be delivered pre-sterilised via the EZ-fill® platform. Altogether, this offers the opportunity for Aidaptus® to be a clinical tool while also a streamlined commercial solution with its flexible filling and hybrid PFS accommodation i.e. a single device design solution for pharmaceutical innovators’ pipelines and portfolios ≤ 2.25ml.
Another option for customers needing to deliver high-volume mAbs is Stevanato Group’s Vertiva® on-body delivery system – composed of a single-use pod with a pre-filled and pre-loaded cartridge combined with a multi-use smart controller. Designed for versatility, Vertiva® supports both full-content bolus injections and basal infusions up to 10mL capacity, making it ideal for a wide range of large-volume therapies. To optimise Vertiva®’s supply chain, Stevanato Group’s capabilities in primary packaging, assembly equipment, and analytical services are complemented by a strategic collaboration with leading contract manufacturing organisation Thermo Fisher Scientific, that offers optimised fill-finish and final assembly services.
Alongside its portfolio of novel solutions for mAbs, proprietary primary packaging and a suite of testing services, Stevanato Group also offers flexible inspection technology for any stage of the product journey – from lab development to high-volume production – and state-of-the-art tailor-made assembly and packaging solutions. It all adds up to a one-stop shop for even the most challenging mAb product.