CHEMICALS KNOWLEDGE HUB issue 2 / October 2025

56 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 ROUNDTABLE that are safe, cost-effective and accessible at scale. For RNA-based drugs, this requires manufacturing partners who can provide continuity from early research to commercial production. Our vertically integrated model was built with this in mind. By unifying raw materials, GMP drug substance and drug product capabilities within a single organisation, we eliminate supply handoffs that can delay development or compromise traceability. This ensures smoother progression from concept to clinic and faster delivery to patients. We also recognise that large-patient indications, such as cardiometabolic disease, will test the limits of global supply. To serve these populations, we’ve invested in high-capacity infrastructure and nextgeneration enzymatic technologies that enable sustainable, large-scale manufacturing. By embracing patient-centric principles and advancing our partners’ science with speed and reliability, we help ensure their medicines achieve full potential for patients worldwide. LS. Patient-centric care is transforming expectations across the value chain, including how and where therapies are produced. We’re continuously adapting by focusing on speed, flexibility, and quality. This means enabling our clients to reduce time to market whilst maintaining compliance and patient safety. We’re also delivering solutions to support smaller, more targeted batches and decentralised manufacturing models that reflect the direction of patient-centred innovation. What impact is the rise of biopharma and advanced therapies having on your supply chain and manufacturing decisions? ML. Advanced therapies can benefit from a fundamentally different supply chain model, one that integrates technical depth, regulatory rigour and scalability. At Hongene, this has driven major investments in global, vertically integrated manufacturing infrastructure, enabling control from nucleoside raw materials to finished oligonucleotide and mRNA drug products. This model enhances resilience by reducing dependence on fragmented vendor networks and enables full batch-level traceability – a regulatory expectation. It also allows us to meet diverse customer needs, from the aggressive timeline expectations of small biotech to multi-ton manufacturing for global pharma. Our supply chain strategy is also guided by technology innovation. Chemoenzymatic ligation enables high-purity siRNA and sgRNA production at scale, with improved sustainability compared to traditional synthesis methods. Our structureguided mRNA chemistry designs are increasing the duration and potency of drugs such as PCVs. Innovations like these position us not just as a supplier, but as a strategic enabler of nextgeneration RNA therapeutics. As biopharma advances, we have evolved far beyond raw materials into a full-service CDMO and innovator, enabling partnerships that bring some of the world’s most advanced medicines to patients. BC. The demand for patient-centric care is transforming how therapies are developed, manufactured and delivered and this has direct implications for our business strategy. Patients today expect not only effective medicines, but also treatments that are easier to access, administer and integrate into their daily lives. This has shifted the focus toward therapies that minimise hospital stays, reduce treatment burden and improve quality of life, which in turn shapes how we work with our partners across the value chain. One clear outcome is the rising demand for alternative formulations and delivery routes. Monoclonal antibodies remain the cornerstone of biologics and continue to expand their clinical footprint. In oncology, PD-1/PD-L1 inhibitors like pembrolizumab and nivolumab are no longer reserved for late-stage cancers, but are increasingly approved in earlier lines of therapy and across multiple tumour types. Similarly, in autoimmune diseases, TNF and IL-17 inhibitors are being positioned in earlier treatment algorithms, often supported by real-world evidence demonstrating durable efficacy and safety. Patient-centricity also drives our focus on rare and orphan diseases. Many of these conditions affect small, highly specific populations with significant unmet needs. The ability to rapidly scale flexible bioprocesses for orphan drugs is critical to ensure timely patient access. Like I previously said, emerging modalities such as ADC and multi-specific antibodies also fit within this patient-centric framework. In addition, the growing biosimilar market adds another layer of patient-centric impact. MM. Patient-centric care has become one of the defining forces shaping pharma and, by extension, CDMOs. It demands greater agility, speed and reliability in development and supply. For Axplora, this means expanding flexible, multipurpose facilities that can serve both early-phase

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