Nanoform announced the cost leadership position of its CESS^® technology, the culmination of more than a decade of scientific, engineering and manufacturing innovation leading to a cumulative scale up factor of more than one million.

Spray-dried ASDs have been the pharmaceutical industry’s preferred technology for improving the bioavailability of poorly soluble small molecule medicines. However, they often require significant quantities of polymers, organic solvents, and complex downstream processing which all adds to their cost position. CESS^® changes that equation by providing highly competitive manufacturing economics through smart manufacturing, similar or better performance than ASDs with lower pill burden, and less environmental impact.

“Historically, pharmaceutical companies have accepted trade-offs between performance, sustainability and cost,” said Christian Jones, CCO of Nanoform. “CESS^® demonstrates that those trade-offs are no longer necessary. We believe Nanoform is now uniquely positioned as a value leader, environmental leader and increasingly a cost leader. Based on recent business intelligence we believe that Nanoform’s CESS^® process is now significantly more cost effective than either European or US based spray dried dispersions and potentially even below Asian low-cost spray drying.”

Cost Leadership

Over the past decade, Nanoform engineers have transformed CESS^® from a lab-scale process into a commercial manufacturing platform producing kilograms per hour and supporting multi-ton annual production. Nanoform offers both clinical and commercial GMP CESS^® capacity in Helsinki, Finland.

Compared with spray drying, CESS^® offers lower cost of goods, high yields, lower investment requirements, reduced excipient usage, simplified downstream processing, and a manufacturing architecture designed for efficient commercial-scale production. Nanoform believes this progress positions CESS^® to compete directly with conventional spray-drying economics while delivering superior product characteristics.

Value Leadership

Nanoform has demonstrated that nanocrystalline formulations produced using CESS^® can deliver exposure comparable to marketed ASD products while enabling dramatically higher drug loading. In programs such as nanoenzalutamide, Nanoform increased drug loading from 12% in the marketed ASD benchmark to 40%, enabling much smaller dosage forms and reduced pill burden for patients.

The result is the potential for at least comparable pharmacokinetic performance, fewer and smaller tablets, reduced excipient burden and differentiated product profiles that create value throughout the product lifecycle.

Environmental Leadership

Conventional spray drying commonly relies on substantial volumes of organic solvents including methanol, ethanol, acetone, dichloromethane and DMSO, whereas CESS^® only utilizes recycled pharmaceutical-grade carbon dioxide as its processing medium. The technology can substantially reduce or eliminate solvents, polymers, and excipients while simplifying manufacturing operations.

The combination of recycled CO₂, reduced raw material consumption, and streamlined processing creates one of the pharmaceutical industry’s most compelling sustainability propositions while simultaneously improving manufacturing economics.

A New Generation Beyond Spray Drying

“First Nanoform became a value leader through improved patient-centric formulations. Then we became an environmental leader through our sustainable CO₂-based platform. Through years of process intensification, scale-up and engineering innovation, we are now establishing cost leadership as well,” concluded Jones.

“Spray drying transformed formulation development over the past twenty years. We believe CESS^® represents the next generation: at least comparable performance, higher drug loading, more sustainable and competitive economics in a single platform.”