- Recipharm has extended its high potency manufacturing capabilities at its Leganés site in Spain to GMP pilot scale, enabling a route from development through to commercial supply.
- The new pilot-scale suite supports dry granulation, tableting and coating for high potency oral solid dose products, while the company’s ReciPredict platform can reduce active pharmaceutical ingredient (API) consumption by up to 70% during development and scale-up.
Recipharm, a contract development and manufacturing organization (CDMO), has extended its high potency manufacturing capabilities at its Leganés site in Spain to good manufacturing practice (GMP) pilot scale. The expansion is intended to provide customers with a single manufacturing route for high potency products, from development and clinical batches through to commercial supply.
The new pilot-scale suite supports high potency oral solid dose (OSD) products and is built around dry granulation, with tableting and coating performed within the same containment area. The same pilot-scale equipment can produce clinical and small-scale commercial batches. When larger volumes are required, products can be transferred to the site’s commercial manufacturing lines without moving to another site, which the company says reduces scale-up risk and supports regulatory dossier filings.
The suite is supported by Recipharm’s proprietary ReciPredict platform, which uses material science, modeling and simulation to optimize formulation and process design. According to the company, the platform can reduce API consumption by up to 70% during development and scale-up. Recipharm said dry granulation is suited to high potency compounds because it avoids moisture and heat, supports containment and operator safety, uses scarce or high-value materials efficiently, and does not require solvents.
The new capabilities build on Leganés’ existing commercial high potency operations, which handle compounds up to occupational exposure band (OEB) 5 and have a capacity of approximately 250 tonnes per year. The site also manufactures and packages conventional and film-coated tablets and capsules, with serialization and in-house quality control laboratories. It is approved by the U.S. Food and Drug Administration, Spain’s AEMPS under EU GMP, and Japan’s Pharmaceuticals and Medical Devices Agency.
Recipharm’s wider high potency network also includes OEB 3 and OEB 4 oral solid dose manufacturing, as well as OEB 4 sterile fill-and-finish services for prefilled syringes, liquid vials and prefilled cartridges. CEO Greg Behar said the expansion responds to growing demand for high potency medicines across areas including oncology and rare diseases, while specialized high-containment facilities can take more than two years to become operational.
