The Spain-based contract development and manufacturing organization (CDMO) has been running its contract development and manufacturing spray-drying service for slightly over a year. At the center of the operation is a GEA Niro Mobile Minor spray dryer, designed to manufacture smaller volumes of powder samples.
Manuel Leal, Idifarma business development director, told Outsourcing-Pharma the spray-drying facility will help his company assist clients in dealing with a particularly vexing challenge drug developers frequently face.
“Poor solubility is one of the key problems for drug development. It is estimated that as much as 90% of drugs in the pipeline have poorly soluble APIs,” Leal told us.
“Spray-dried solid dispersion is one to the most suitable solutions to this challenge,” he added. “Idifarma is focused in providing our clients with the best technological solutions to the problems in their pipelines, so investing in GMP spray drying capabilities was the perfect fit for us.”
Additionally, Leal said, spray drying is effective of improving solubility of BCS class II and IV molecules. Also, he told us, the technology can be harnessed to process thermo labile APIs and allows process control in achieving desirable characteristics in terms of flow property, particle size distribution, and other attributes.
Leal added that in the months since the spray-drying capabilities were put into service, the response among Idifarma customers has been “very positive.”
“There are just a handful of companies able to handle OEB4 drugs with this technology, and we are probably the most nimble partner, so we are catering to a variety of customers, from start-ups all the way up to Big Pharma companies,” he said. “We are developing and manufacturing mostly innovative and hybrid drugs -505 (b)(2)-, although we are also collaborating with this technology for generic drugs.”
In addition to bringing on spray drying capabilities, Idifarma in recent years has expanded its serialization and capsule-filling capabilities. Leal told OSP the company plans in the near future to increase its contract manufacturing business, expand specialized capabilities for small-scale and highly potent drugs, and make other strategic investments to increase its market presence.