Cerbios’ HPAI Plant Passes Swiss InspectionBy
Cerbios-Pharma, a Lugano, Switzerland-headquartered contract development and manufacturing organization, has passed a SwissMedic cGMP inspection for its new super critical carbon dioxde atomization plant. The plant is now authorized for both clinical-scale and commercial-scale supply of high potency active ingredients (HPAIs) of submicron crystal-size, intended to improve the bioavailability of poorly soluble drugs.
In March 2015, Cerbios invested in the atomization plant for the purpose of engineering particles using super critical fluid technology capable of generating micro and nano-API particles with very narrow particle-size distribution. This investment expanded Cerbios’ contract manufacturing services platform in the area of HPAIs, either in conjunction with the production of the HPAI itself or as a standalone option. The plant was developed to handle HPAIs at 200 grams cGMP scale. The scale-up in the plant enables 50 grams to 200 grams of output capacity per batch of HPAIs.