Micro-Sphere has added to its contract development and manufacturing expertise with new spray drying technology and increased high containment capabilities.
The Swiss contract development and manufacturing organization (CDMO), which specializes in spray drying and capsule filling, has invested more than €3.5 million bringing on-line a new PSD2 spray dryer and associated technical area and clean room at its state-of-the-art facility in Monteggio, Switzerland.
The new equipment expands the CDMO’s spray drying capabilities in both clinical and commercial manufacturing.
“Customer demand for GMP spray drying is increasing because of the need to support poorly soluble drugs,” said Michael Grassberger, CEO, Micro-Sphere. “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 COVID19.”
Alongside the PSD2 spray dryer the company has also invested in its high containment capabilities, (specifically dispensing) with the purchase of a rigid glove box isolator which allows handling of HAPI with an OEL (Occupational Exposure Limit) down to 30ng/m3.
Grassberger said, “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 recognized as a key-partner to this industry.”
The new equipment is part of the CDMO’s continued investment into expanding its GMP manufacturing capabilities and comes in response to increased demand for spray drying and inhalables from companies ranging from big pharma to small virtual firms.
From its EU-GMP, FDA and SwissMedic approved facility in Moncteggio, Ticino, Micro-Sphere’s expert team supports customers in the U.S., Europe, New Zealand and Asia with spray drying capabilities for the development and manufacture of both potent and non-potent pharmaceutical products, with a particular focus on inhalable dosage forms.