OSD
OSD
Author: Lidia Garcia Martin, MSAT & New Productions Head, Recipharm
Throughout 2025, the pharmaceutical landscape was reshaped by the accelerating demand for targeted and increasingly complex therapies. Growth in oncology, immunology, and precision-medicine pipelines intensified the focus on molecules with higher potency and narrower therapeutic windows. These compounds offer notable clinical promise but demand far more sophistication in handling, containment, and process control.
As sponsors advanced more niche and personalised modalities, manufacturers were pushed to adopt holistic approaches to safety and quality. For example, integrating equipment design, facility layout, and procedural controls to manage occupational exposure and maintain compliance.
The industry also saw expanded investment in scalable containment solutions, digitalised process oversight, and the technical capabilities required to progress highly active compounds through development. This year highlighted that successful drug development depends on managing potent materials safely, efficiently, and with strong technical discipline.
A key trend we can expect to see drive innovation in 2026 is the surge in high-potency active pharmaceutical ingredients (HPAPIs) for high-potency drug development, as more therapies rely on highly active compounds for targeted efficacy. This shift places a premium on specialist capabilities to ensure both operator safety and predictable product quality, particularly advanced containment, automation, and data-driven process control.
The next wave of progress will likely stem from robotics and closed-system technologies that reduce manual handling and mitigate exposure risks, alongside digitalised monitoring that strengthens science-based decision-making and enhances risk management. As developers seek to move potent candidates from early development toward commercial readiness, technical transfer expertise and integrated containment strategies will become differentiators.
High-potency manufacturers are prioritising energy-efficient heating, ventilation, and air conditioning (HVAC) systems as well as facility layouts that minimise waste and unnecessary airflow demands. Process selection is also evolving, with solvent-free or solvent-reduced techniques gaining traction, supported by closed systems and isolators that limit emissions and improve material efficiency.
Sourcing strategies are increasingly favouring suppliers capable of supporting greener operations, as organisations now measure environmental progress with far greater precision. Metrics around energy use, waste-stream reduction, carbon footprint, and water consumption are becoming embedded within broader operational performance indicators, aligning procurement decisions more closely with sustainability goals.
The ongoing push for sustainability will also influence innovation. Developments in through solvent-free processing and efficient HVAC design will help enable more resilient development of the most complex treatments entering pipelines in 2026.
As more high-potency programmes enter the development pipeline, manufacturers planning for 2026 should prioritise ensuring facilities are ready to meet the complex needs of these therapies safely and consistently. This includes investment in next-generation containment, closed systems, isolators, engineered HVAC infrastructure and segregated zoning that maintains robust primary and secondary controls.
Upgrading automation and robotics capabilities will be equally important, reducing manual handling and exposure risks while improving process robustness and reproducibility. At the same time, integrating digitalised monitoring systems will enable real-time verification of containment performance, support data-driven risk assessments, and facilitate smoother technical transfers — ensuring these advancements work together to elevate high-potency operations.
Given the complexity of scaling high-potency products, facilities must also ensure adaptability, with flexible process suites and equipment that can transition seamlessly from development to commercial production. By proactively modernising infrastructure, manufacturers can reduce risk and remain competitive as potent-molecule pipelines continue to expand.