Recipharm, a global contract development and manufacturing organization (CDMO), has expanded high-potency drug manufacturing capabilities at its Leganés, Spain site to include Good Manufacturing Practice (GMP) pilot-scale production for oral solid-dose products.

The new suite supports compounds up to occupational exposure band (OEB) 5 and uses dry granulation, tableting, and coating within the same high-containment area. The equipment can produce both clinical and small-scale commercial batches, allowing products to move to the site’s larger commercial lines without transferring manufacturing to another facility.

The dry-granulation process avoids solvents and is designed to preserve active pharmaceutical ingredient (API) stability, while supporting containment and efficient use of limited or costly materials. Recipharm also uses its ReciPredict formulation and process development platform, which the company says can reduce API consumption by up to 70% during development and scale-up.

The pilot-scale expansion builds on the Leganés site’s existing high-potency commercial operations, which have approximately 250 metric tons of annual capacity for compounds up to OEB 5. The facility also manufactures and packages tablets and capsules and has approvals from the U.S. Food and Drug Administration, Spain’s AEMPS, and Japan’s Pharmaceuticals and Medical Devices Agency.

The expansion follows Recipharm’s September 2026 collaboration with Swiss biotechnology company CanVirex to develop a scalable manufacturing process for an investigational oncolytic measles virus therapy. The work, based at Recipharm’s Cuxhaven, Germany facility, includes cell and virus banking and process development toward future GMP manufacturing.