With patient-centric approaches to drug packaging becoming more prevalent certain aspects of biologics must be considered. Here, Fran DeGrazio, vice president of Scientific Affairs & Technical Services at West Pharmaceutical Services, runs through key considerations and how specific designs can help with patient adherence.
Putting the patient first
Over the past several years there has been a steady shift in the industry toward a more patient-centric approach to the development of drug packaging components and delivery systems — elements that play a key role in helping to ensure the integrity of injectable drug products — largely driven by concerns around patient safety.
Most biologics currently in development take an injectable form and the top-line consideration for any injectable drug is the patient. As many injectable biologics are highly viscous, they may require larger containment systems and slower dosing of large volumes of the drug over time.
Additionally, biologics can have sensitive chemical compositions that pose the potential for interaction with materials traditionally used for packaging and delivery systems. Therefore, it is essential to package biologics with components that can help protect the quality, safety and efficacy of the drug product.
Special considerations
Fran DeGrazio, vice president of Scientific Affairs & Technical Services at West Pharmaceutical Services
Fran DeGrazio
One overarching consideration is the quality of drug packaging and delivery systems. Regulatory bodies around the world are asking manufacturers to build quality into their products from the start to ensure consistency throughout a drug’s lifecycle and to minimise risks.
Given this shift and what is at stake, the application of quality by design (QbD) principles in the development and manufacture of biologic drug products driven and supported by regulatory guidance has been widely adopted within the biopharmaceutical industry. A solution offered by West utilises this approach — NovaPure components — which help to mitigate the risks and maximise the efficiencies of fill-finish processing.
Another consideration in evaluating drug packaging is the need to understand storage and distribution temperatures. Some of these conditions can present a significant challenge for drug packaging. To combat these challenges, West offers Daikyo Crystal Zenith vials and containers made from a novel cyclic olefin polymer. These are compatible with extreme low temperatures and the polymer’s low reactivity reduces the risk of drug contamination.
Another important consideration for biologics containment systems is mitigating the risk of particulate caused by potential interactions that can occur at the biologic-container interface or the biologic-air interface. Quality expectations have risen such that one contaminated vial or syringe can cause an entire lot to be discarded, and this can have a huge financial impact on the pharmaceutical industry. Concerted efforts to reduce particle generation at all steps of the manufacturing process can bring large benefits.
With more manufacturers implementing the use of prefilled syringes and self-injection systems for biologics interactions between the drug, the container and the patient are vital considerations. In some cases, interactions between the drug, certain components and materials used with prefilled syringes (e.g., silicone oil) may cause issues such as protein aggregation that can contribute to quality or safety issues.
It is, therefore, integral for manufacturers to pay close attention to the material characteristics of the prefilled syringe selected for their biologics. Through a careful consideration of all elements of the integrated drug delivery system the potential for protein aggregation can be minimised and drug product stability improved.
Patient adherence
Proprietary drug delivery systems are being developed to aid patients with self-administration while also addressing the specialised needs of biologics.
An emerging trend is wearable injectors. These systems may include polymer cartridges that can be designed to hold high-volume doses of sensitive biologics and offer subcutaneous, programmable electronic injections, delivering the drug over an extended time period.
While many patients are comfortable loading their devices — especially those who have been treating a chronic condition for years — others may take their medication once a month or suffer from conditions where they are at risk of forgetting the steps of properly loading the device. For these patients, a single-use, preloaded large volume injection device can make sense.
Additionally, user interfaces can be optimised by incorporating human factors practices and appropriate electronic indicators and feedback, aiding patient adherence and caregiver monitoring.
Patient-centricity
Advanced biologics often have very specialised needs around containment and delivery that can, in turn, influence the selection of appropriate packaging components. It’s important to consider how the biologic will be delivered to the patient.
Most patients are not trained medical practitioners; therefore, they need delivery systems to be intuitive. As such, self-injection systems for administration are becoming more popular.
These systems can give patients newfound freedom to self-manage their diseases outside of traditional healthcare settings. The design of these systems is, therefore, important and should have a patient-centric focus to help improve adherence and outcomes.