- Recipharm has announced a strategic investment to expand high-potency oral solid dose (OSD) clinical and pilot capabilities at its Leganés, Spain site, with operations scheduled by year’s end.
- The expansion supports phase III programmes, pilot-scale GMP projects and small-scale commercial production within a high containment environment.
Recipharm, a global CDMO, has announced a strategic investment to strengthen its high-potency oral solid dose (OSD) capabilities at its Leganés site in Spain. The new high-potency clinical and pilot capabilities are scheduled to be operational by the end of the year and are intended to support customers from development through commercial supply.
The expanded offering will enable onboarding of high-potency phase III clinical programmes, including process transfer and optimisation, as well as pilot-scale GMP projects and small-scale commercial production of 10kg or more. The capabilities are particularly suited for paediatric and orphan drug products requiring high potency containment. The site already has commercial OEB 5 containment capability (0.1–1µg/m³) and experience supporting high-potency oncology products. Leganés is an FDA-approved site within Recipharm’s global contract manufacturing network.
The investment expands upstream capabilities, allowing customers to accelerate late-stage development, de-risk scale-up or tech transfer, and transition into commercial manufacturing within the same high potency environment. The site now offers integrated assets including a coater, roller compactor, in-process control systems and analytical capabilities within a single high containment facility. Recipharm stated that this integrated setup supports scale-up efficiency, dossier filings and commercial supply robustness.
“High-potency oral solid dose manufacturing remains one of the most capacity-constrained and technically demanding areas in our industry. By adding dedicated high-potency development and pilot capabilities at Leganés, we are strengthening our ability to partner with customers earlier and support them across late-stage development through clinic to commercialisation.”
Greg Behar, CEO at Recipharm
Beyond Leganés, Recipharm also provides commercial-scale OEB4 manufacturing capability and OEB4 sterile fill and finish for pre-filled syringes, liquid vials and pre-filled cartridges across its global CDMO network. The company said the latest investment reflects growing demand for safe, scalable and high-quality high-potency pharmaceutical development and manufacturing solutions.
