Recipharm Expands High-Potency Capacity in Spain

Editor’s Take: Customers increasingly want smaller, more flexible capacity that can follow a product from the clinic to its first commercial batches. Learn more about the changing HPAPI manufacturing landscape.

Recipharm, a global contract development and manufacturing organization (CDMO), has extended the high potency offering at its Leganés site in Spain to GMP pilot scale, giving customers a single high containment route from development to commercial supply.

“High potency compounds are a fast-growing part of the industry’s pipeline, from oncology to rare diseases, and with new high containment facilities taking more than two years to come online, specialist capacity is struggling to keep pace,” said Greg Behar, CEO of Recipharm. “We are moving ahead of that demand. At Leganés, customers can bring their high potency programs to one partner, from the first pilot batches all the way to commercial supply, helping them get these medicines to patients sooner.”

The new pilot scale suite is built around dry granulation, with high potency tableting and coating in the same containment area. Dry granulation is particularly well suited to high potency drugs: it preserves API stability without moisture or heat, improves containment and operator safety, makes efficient use of scarce or high value materials, and is solvent free. The suite is supported by Recipharm’s proprietary ReciPredict platform, which uses material science, modelling and simulation to optimize formulation and process design, reducing API consumption by up to 70% during development and scale-up, an important saving where API is scarce and costly.

The new capabilities build on Leganés’ commercial high potency operations, which handle compounds up to OEB 5 with a capacity of around 250 tons per year. The site also manufactures and packages conventional and film coated tablets and capsules, with full serialization and in-house quality control laboratories. It is approved by the U.S. FDA, AEMPS (EU GMP) and Japan’s PMDA.