IDIFARMA has announced new GMP spray drying capabilities which will make it one of the very few contract development and manufacturing organisations (CDMO) to offer spray drying technology for highly potent drugs up to Category 4 OEL/OEB.
The Spanish CDMO, which specialises 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, which involves a significant investment for the company, will be installed and qualified in mid-2018 and will give Idifarma spray drying capacity for niche commercial products and clinical batches.
Luis Oquiñena, general manager and co-founder of Idifarma said: “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.
“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 serialisation and capsule filling capabilities and strengthens Idifarma’s position as a specialised 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.
Oquiñena added: “Our investment in new technologies reflects our continued success within the CDMO market and our intent to further grow our business with specialised capabilities. As well as new technologies we are also investing in qualified and experienced staff to deliver our services and now have 120 employees on site. As customer demand for our niche CDMO services continues to grow we fully expect both investments and staff numbers to increase steadily in the coming year.”