The French-privately owned contract manufacturing organisation (CMO) has installed a Hosokowa Alpine Micronizer at a facility in Feucht, Germany that is operated by its active pharmaceutical ingredient (API) and oral solid dose division, Excella GmbH.
Excella, which was bought by Fareva in 2008, already had a Hosokowa Alpine Pin Mill for large volume processing. The new micronizer, in contrast, is designed for smaller volume work and will be used for high potency API particle production.
Fareva spokesman George Hlass said: “We’ve observed the trend that more of our customers require micronization for their HPAPIs.”
He added that: “Our customers see increasing value in simplifying their supply chain and the synergies associated with doing their API and OSD development and manufacturing at Excella.”
Fareva’s rationale echoes what fellow CMO Catalent said when it acquired API particle tech firm Micro Technologies last November.
At the time, the newly public US contractor told us customer demand for micronization is being driven by the drug industry’s focus on lower solubility BCS class II and IV APIs.
Fareva also said the additional micronization capacity “strengthens our one stop shop model,” under which Excella is responsible for producing both the API and the dosage form on customers’ behalf.
This also fits with observations about the Catalent investment. At the time John Kreger, an analyst at William Blair, said: “Particle size engineering is typically employed in the preclinical or Phase I stage of development—well before Catalent usually competes for a new molecule.
Fareva did not respond to a request for comment ahead of publication.