Recipharm has added pilot-scale manufacturing for high-potency medicines at its Leganés site in Spain, extending the facility’s capabilities from development through clinical production and commercial supply.
The new suite operates under Good Manufacturing Practice standards and can produce clinical and small commercial batches using the same equipment. It handles high-potency oral solid-dose products containing compounds classified up to Occupational Exposure Band 5, or OEB 5.
For products requiring larger volumes, manufacturing can move to commercial lines at the same site rather than transferring to another facility. Leganés already has approximately 250 tonnes of annual commercial high-potency capacity.
The pilot suite centers on dry granulation, with tableting and coating performed within the same containment area. Recipharm said the process avoids moisture, heat and solvents while supporting containment and efficient use of active pharmaceutical ingredients.
The suite also uses the company’s ReciPredict platform, which combines material science, modeling and simulation for formulation and process design. Recipharm said the platform can reduce active ingredient consumption by up to 70% during development and scale-up, although the announcement provided no supporting study data.
Chief Executive Greg Behar said developers increasingly need smaller, flexible manufacturing capacity for high-potency compounds, including medicines for cancer and rare diseases.
The Leganés facility also manufactures and packages conventional tablets, film-coated tablets and capsules. It has in-house quality control laboratories and regulatory approvals from authorities in the United States, European Union and Japan.