The company has installed a PSD2 spray dryer and associated technical area and cleanroom at its facility in Monteggio
Micro-Sphere has invested more than €3.5m ($4.05m) to expand its spray drying and containment capabilities. The Swiss CDMO, which specialises in spray drying and capsule filling, has installed a PSD2 spray dryer and associated technical area and cleanroom at its facility in Monteggio. The equipment expands the CDMO’s spray drying capabilities in both clinical and commercial manufacturing.
Micro-Sphere CEO Michael Grassberger said: “Customer demand for GMP spray drying is increasing because of the need to support poorly soluble drugs. This is not our first spray dryer project and we have used our experience, plus GEA’s professional support, to accelerate this project and meet customer demand despite the restraints brought by COVID-19.”
Alongside the PSD2 spray dryer the company has also invested in its containment capabilities, (specifically dispensing) with the purchase of a rigid glove box isolator which allows handling of HAPI with an occupational exposure limit (OEL) down to 30 ng/m3.
Grassberger added: “There has been a significant rise in demand for high potent compounds to be spray dried, with an increasing incidence of generic HPAPI, which confirmed our decision to invest in our high containment capabilities. “This investment diversifies Micro-Sphere’s capability to address these demands and broadens our manufacturing services, meaning we can spray dry high potent compounds on a big scale, whilst also boosting our high containment expertise.“Greater awareness and concern for safety in the industry are all factors that have led to a need for a well-defined multiple response to containment issues. Micro-Sphere wants to become and be recognised as a key-partner to this industry.”
The equipment is part of a continued investment into expanding the company's GMP manufacturing capabilities and comes in response to increased demand for spray drying and inhalables.
From its Monteggio, Ticino, facility, the company’s team supports the development and manufacture of both potent and non-potent pharmaceutical products, with a particular focus on inhalable dosage forms.