How advances in primary packaging are helping patients administer biologics at home

Anil Kumar Busimi - senior global product manager for SCHOTT iQ Platform at SCHOTT, explores how innovation in packaging is giving patients more options to administer medication from home. 

The rise of biologics continues to dominate the global pharma drug pipeline, yet it is the administration of these drugs that presents a challenge to the pharma packaging. As biologics have become more structurally complex than their predecessors over the past decade, they require special packaging to ensure drug stability throughout shelf life.

More so, a changing market has introduced the possibility of home administration for biologics, which is being driven by the goal to lower healthcare costs. This is supported by advances in f primary packaging solutions. Medication now needs to be filled, stored and administered in a single container type, while at the same time allowing for easy, safe and accurate injection administration. This can be achieved with pre-filled syringes (PFS) but also by using auto-injectors and wearable devices.

Safe administration with pre-filled syringes

The key benefit of PFS is that they make injections easier and safer for both healthcare professionals and patients. The drug is already filled in the container in its exact dose, which prevents the risk of dosing inaccuracy, while the administration process is often supplemented by auto-injection or safety devices. In addition, pharmaceutical companies can benefit from less overfill in PFS in comparison to using vials. Furthermore, PFS can be used directly for aseptic filling as they are already washed, siliconized, fitted with a tip cap or needle guard, and sterilised, which saves costs and process steps.

To meet the needs of biologics, available syringes made from borosilicate glass tubing were specifically developed for highly sensitive formulations. For example, the 1ml long syriQ BioPure glass syringes from SCHOTT, feature lower adhesive residues and a lower tungsten level (ICP-MS certificate available) compared to standard syringes, which supports a low extractables and leachables (E&L) profile while ensuring drug stability. The syringes come with elastomer components, which further provide a low E&L profile to additionally reduce the risk of potential drug/container interactions during the entire shelf life. At the same time, the optimised siliconization process, which provides a uniform inner coating, improves the functionality with conventional safety devices and autoinjectors making the administration process safer for patients.

Eliminating silicone to keep highly sensitive biologics stable in ultra-pure prefilled syringe systems

In PFS, one of the components that drugs may interact with is silicone. The substance has long been deemed a necessity to help reduce the injection force needed to administer drugs and make the treatment more comfortable for the patient. However, an estimated 10-15% of the biologic pipeline drugs are ultra-sensitive to silicone. Pharmaceutical containers, which contain silicone, are therefore not suitable to package such drugs.

When PFS refrain from siliconization of the syringe barrel, an accurate geometry of the container becomes important to maintain a consistent gliding force. This is possible, using 100% inspection of the glass tubing, which ensures tight dimensions and high cosmetic quality of each barrel. Currently, the only commercial available option for glass PFS is the syriQ BioPure silicone-free syringe system combined with GORE ImproJect plungers. The product combination consists of a PFS system with a silicone free glass barrel and plungers that eliminate the need for silicone as a lubricant in pre-filled syringes. Moreover, the new and tighter tolerances go beyond ISO 11040-4 to provide a smooth self-injection, while including all mentioned benefits of the regular syriQ BioPure portfolio.

Finding the right PFS for injection volume and drug viscosity

The highly viscous nature of some biologics presents another challenge to packaging. The high viscosity level is the result of ensuring efficacy of the treatments by increasing the bioavailability and the Active Pharmaceutical Ingredient (API) concentration. In return, this means that more force is required to inject the drug. Yet if too much force is applied, the injection process may become uncomfortable for the patient and the syringe inside the autoinjector device is at risk of breaking.

While the 1ml long staked in needle is considered the standard for biologics drugs, there is a trend to deploy 2.25ml PFS to also allow higher injection volume and accommodate the increasing viscosity of the biologic drugs. Hence, pharma companies can choose between 1ml long or 2.25ml syriQ BioPure PFS, which both feature high mechanical strength and are compatible with safety devices and auto injectors to make injection safe and improve patient experience.  

Administering large volumes with wearable injectors

The trend of self-administering injectable drugs and the goal to reduce injection frequency is driving the development of wearable injectors or large volume injectors, which are particularly designed for subcutaneously administering injectable drugs in large volume (more than 2 mL) and/or over extended injection time-periods. While wearable injectors are not a new concept, the use in administering biological drugs is a novelty.

Similar to the use of an auto-injector for self-administration, it is the primary packaging in wearable injectors that plays a key role in keeping the drug safe from contamination. At the same time, it is responsible for ensuring optimal functionality to deliver the drug, and must seamlessly fit into the device. Deciding for the right primary packaging for wearable injectors can be a daunting task as the container needs to ensure drug stability, provide container closure integrity (CCI), ensure smooth fill and finish operations and must comply with the relevant regulatory requirements. To reduce the complexity during development and time to market, many wearable injectors rely on proven primary packaging solutions like cartridges. The containers allow designers to choose container length, volume, diameter, neck and flange design, and the stopper and plunger material. Another benefit of cartridges is that many of their functional parameters, particularly glide force, have been tested to full extent according to ISO standards.

The importance of primary packaging

As an integral part of every drug, the primary packaging is responsible for keeping the drug safe until it is administered while improving the patient experience. Relying on a close collaboration early on in the process with the packaging and component supplier, pharma companies are able to find the right packaging for its drug, patient group and administration requirements. For packaging suppliers this allows them to continuously respond to trends in a timely manner and develop varied innovative solutions, which meet the market needs.