Recipharm has announced the expansion of its high-potency capabilities at its Leganés site in Spain to include GMP pilot-scale production.
The site previously offered commercial manufacturing for high-potency active pharmaceutical ingredients (HPAPIs).
The company cited rising customer demand for smaller, more flexible capacity so customers can scale a product from pilot to larger-scale commercial production.
Greg Behar, CEO of Recipharm, said: “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."
We are moving ahead of that demand. At Leganés, customers can bring their high-potency programmes to one partner, from the first pilot batches all the way to commercial supply, helping them get these medicines to patients sooner.
With the expansion, the Leganés site can now produce both clinical and small-scale commercial batches for high-potency oral solid dose (OSD) products using the same pilot-scale equipment, then scale up to the site’s commercial lines without moving to another site, avoiding technology transfer and simplifying the journey from clinical development to market.
The new pilot-scale suite is built around dry granulation, which Recipharm says confers several advantages for high-potency products, including the following:
- API stability: avoiding moisture and heat associated with certain wet-granulation and drying processes can benefit ingredients sensitive to those conditions
- Containment and worker safety: the process can be designed to limit dust generation and exposure, although the level of protection depends on the complete equipment and handling system
- Less API waste: HPAPIs can be extremely expensive and only small quantities may be available during development. Efficient use of material is therefore valuable
- No process solvents: dry granulation avoids the need for granulation solvents.
The suite is also supported by Recipharm’s proprietary ReciPredict platform, which uses material science, modelling and simulation to optimise formulation and manufacturing processes.
The company said that it can reduce API consumption by up to 70% during development and scale-up — a particularly useful saving where API is scarce and costly.
The Leganés site already has commercial high-potency manufacturing operations with a reported capacity of around 250 tonnes per year, handling compounds up to OEB 5.
