OSD
Advancing high potency manufacturing through enhanced containment and sustainable process design
The shift toward high potency APIs (HPAPIs) continues to redefine expectations for pharmaceutical development and manufacturing. These compounds deliver significant therapeutic value, yet require environments engineered for exceptional precision, safety and operational control.
In Pharmaceutical Technology’s 2026 industry outlook, Lidia Garcia Martin, Head of MSAT & New Productions at Recipharm, provides insights into how manufacturing strategies must evolve to meet the rising complexity of high potency programmes.
Strengthening high potency processing performance
High potency compounds introduce requirements that extend well beyond standard production controls. Their therapeutic promise comes with strict containment and process demands, Lidia notes that these molecules “offer notable clinical promise but demand sophisticated handling, containment, and process control.”
To support dependable development and scaleup, manufacturers increasingly rely on:
- Advanced containment systems to protect operators and maintain product integrity
- Closed system processing and automation to reduce manual handling
- Precision process engineering to ensure consistent product performance
- Robust materials handling technologies that limit exposure risks
These elements are fundamental for ensuring safe, reliable and scalable HPAPI manufacturing.
Deepening HPAPI strategy and design considerations
Successfully scaling high potency manufacturing requires strategic alignment across containment, facility design and process engineering. These topics are examined in depth in Lidia Garcia Martin’s webinar, Navigate complexities and design effective HPAPI strategies for success, which focuses on designing robust, future-ready HPAPI strategies.
Embedding sustainability into potent compound facilities
Sustainability has become a core part of facility design and operational decision making, particularly for high potency environments where energy consumption is historically high, “high-potency manufacturers are prioritizing energy-efficient HVAC systems as well as facility layouts that minimize waste and unnecessary airflow demands.”
Evolving process strategies further reinforce this shift, including the use of:
- Energy efficient HVAC and utility systems
- Facility layouts that support streamlined flows and reduced resource use
- Solvent free or solvent reduced approaches that reduce emissions and waste
- Closed systems and isolators that enhance both containment and sustainability
These developments demonstrate how innovation in high potency operations now intersects with broader environmental objectives.
Designing for flexibility and future ready operations
Modern high potency facilities must support a diverse pipeline of complex molecules while enabling smooth transitions from early development to commercial production. Adaptable, modular environments provide the foundation for this flexibility, allowing manufacturers to integrate new technologies, manage varying potency levels and meet evolving client and regulatory expectations.
Lidia Martin, highlights that facility and process choices increasingly support operational efficiency and environmental performance, ensuring high potency operations remain both future ready and compliant.
Read the full industry perspective: Explore the complete analysis of the trends shaping pharmaceutical development and manufacturing in 2026: Industry Outlook 2026: Navigating AI, Sustainability, and Operational Resilience” Published by Pharmaceutical Technology
Explore our High Potent manufacturing capabilities