Idifarma has announced new GMP spray drying capabilities for highly potent drugs up to Category 4 OEL/OEB.
The Spanish CDMO, which specializes in niche and highly potent products, will be one of only three companies in the world offering this type of contract development and manufacturing spray drying service with the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its 4,000 sq. ft EU GMP plant.
The new equipment will be installed and qualified in mid-2018 and will give Idifarma spray drying capacity for niche commercial products and clinical batches.
“We are excited to announce this new service and very proud to be at the forefront of spray drying technology. By making this investment, we will be able to provide contract manufacturing services for intermediate products, and for oral solid drugs we can continue until the finished dosage forms,” Luis Oquiñena, general manager and co-founder of Idifarma said. “This investment is driven by significant client demand, with the market looking for spray drying solutions as a suitable technology to improve the bioavailability of poorly soluble drugs. Idifarma now has all the ingredients to support our customers’ spray drying projects at different scales and contribute to accelerated drug development and manufacturing timelines.”
This announcement follows recent investment in both serialization and capsule filling capabilities and strengthens Idifarma’s position as a specialized contract partner for the development and manufacturing of oral solid dosage forms, including high potency compounds and niche pharmaceuticals requiring small commercial and clinical batches.