Drug delivery
standardisation is a two-year cycle from development to qualification and regulatory approval, assuming no major challenges in the meantime”. The final challenge involves assessing the sustainability of a drug delivery system across its life cycle, because while an innovation may, on the face of it, be more sustainable than the system it is replacing, a more rigorous analysis may show that not to be the case. For example, while a reusable device may appear more sustainable than a disposable one, if patients need to switch to a different dosage, they may have to replace a device that hasn’t reached the end of its natural life. Roche, in common with other pharma companies, uses life-cycle assessment (LCA), which looks at sustainability at every stage of the process.
Pre-filled injection devices and pressurised metered- dose inhalers have come under scrutiny.
Thinking outside the box
Nonetheless, some companies in the pharmaceutical and medical device sectors are rising to the challenge by reimagining traditional drug delivery systems. For example, certain autoinjector platforms are being developed with reusable components and disposable cassettes to reduce environmental impact. These devices often feature patient-friendly designs, incorporating visual and audio cues to guide users through the injection process and confirm dose completion. Connectivity options like Bluetooth and RFID are increasingly being integrated, allowing for automated sharing of dosing data with mobile health applications. Additionally, innovative refill systems are emerging, enabling patients to return used autoinjectors to centralised hubs where automated processes handle disassembly, cleaning, syringe replacement, quality control and relabelling – supporting both sustainability and patient convenience.
There has also been some striking thinking-outside- the-box innovation. Roche has developed a new drug delivery system for treating patients with diabetic macular oedema or diabetic retinopathy. Normally, these patients would receive monthly intravitreal injections of ranibizumab. Roche’s Susvimo, however, is a surgically implanted port delivery system (PDS) that continuously releases ranibizumab into the eye and requires refilling only every six or nine months. As well as being more sustainable, it benefits patients. “It significantly reduces the burden of frequent invasive procedures and the associated travel while maintaining comparable vision outcomes,” says Fuetsch. Secondary packaging also offers potential for greater sustainability. Because it doesn’t touch the drug directly, the regulatory requirements are less strict. Nonetheless, says Fuetsch, secondary packaging “still needs careful assessment and validation. This is due to the complexity of protecting contents during transport and storage, especially when temperature controlled.” And while Roche is ahead in the transition of reuse targets for transport packaging, Fuetsch adds that “implementation and
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Collaboration is key to improving sustainability
In a sector where regulators understandably prioritise patient safety, how can pharma companies make sure that their products and processes also meet sustainability targets? The solution requires regulators to collaborate more closely, both with manufacturers and with each other, to reach a consensus on how sustainability principles could be integrated into drug development. As Fuetsch says, regulators “play a crucial role in aligning global regulations with sustainable drug delivery practices”. Roche, she says, encourages regulators “to foster a flexible, global framework that supports innovation, patient access and sustainability simultaneously”. Ideally, the future will see greater harmonisation of environmental standards across the regions covered by the ICH, as well as integration of sustainability metrics in regulatory submissions. Fuetsch argues that a harmonised global framework is crucial for a smooth transition to avoid conflicting requirements across the EU and international legislations, making the framework too complex to navigate: “Sustainability rules should be aligned and developed in consideration of existing pharma and adjacent frameworks impacting the healthcare sector.”
This collaboration is already starting to happen. There has been increasing interest in adopting LCA standards for evaluating environmental impacts across a product’s life cycle. Fuetsch particularly welcomes the upcoming British Standards Institute (BSI) standard, PAS 2090:2025, which is designed to establish product category rules (PCRs) for conducting LCAs of pharmaceutical products. Expected to be the first such specification publicly available and globally applicable, it aims to harmonise environmental evaluation. “Previously, a lack of such a standard led to inconsistent results for similar products,” says Fuetsch. “This collaboration shows how industry and regulators can effectively create unified sustainability frameworks.” ●
www.worldpharmaceuticals.net
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