OSD
Key trends shaping high-potency API manufacturing in 2026
2026 is expected to mark an important milestone for high-potency API (HPAPI) manufacturing. As precision medicine continues to evolve, and more oncology and immunology programmes depend on highly active compounds, manufacturers are under increasing pressure to deliver processes that combine safety, scalability and regulatory robustness.
Against this backdrop, three themes are emerging as key drivers of progress: automation, digitalisation and sustainability.
Automation is playing a growing role in reducing manual intervention across HPAPI operations. Robotics and automated handling systems help minimise operator exposure while supporting more consistent and robust processing. In parallel, containment strategies are becoming increasingly integrated. Closed systems, isolators and advanced heating, ventilation and air conditioning (HVAC) infrastructure are being designed to work together, allowing primary and secondary containment controls to function more effectively throughout the manufacturing lifecycle.
Digitalisation is further reshaping high potency manufacturing. Real time monitoring and data driven process control are improving data availability and process understanding, enabling science-based and fact based decision making. These capabilities support more proactive risk management, help validate containment performance, and enable smoother technical transfer and scale-up from development into commercial manufacturing.
Sustainability is also moving to the centre of HPAPI manufacturing strategies. Manufacturers are increasingly adopting solvent-free or solvent reduced processing, energy-efficient HVAC solutions and more sustainable waste-management practices. These efforts reflect a broader industry shift towards reducing environmental impact while maintaining operational performance, safety and compliance.
Together, these developments are enabling CDMOs and pharmaceutical companies to better manage risk, improve efficiency and maintain high standards of quality and safety. As demand for high potency APIs continues to grow, the ability to integrate automation, digitalisation and sustainability into manufacturing strategies will be critical to meeting future development and supply needs.
