Micro-Sphere Invests $5 Million to Expand GMP Manufacturing Capabilities
The investment allows the Swiss site to benefit from infrastructure upgrades that include an increased production area for additional capsule filling equipment under containment, new laboratory space for inhalation testing and characterization of powders, as well as additional warehouses and offices.
Matteo Berlusconi has been appointed site manager of the plant and is responsible for overseeing the practical implementation of the company’s ambitious growth plans.
He said, “Since 2017, Micro-Sphere has invested nearly €30 million to improve performance and gain efficiencies through facility and capacity upgrades. In the last year alone we have installed a second PSD-2 spray dryer to add more flexibility and capacity for clinical and commercial manufacturing, two additional MG2 capsule filling machines to increase our capsule filling capabilities low dosage and a Malvern 3000 in our Quality Control Lab for PSD measurement to match our customers’ technology.
“This latest investment is another example of how we continue to invest and grow to meet market demands and work with our customers to improve drug development and delivery.
“We will continue to meet industry demand and our ability to undertake more complex and larger scale projects on site is already being taken to the next level with a new R&D department to offer formulation development expertise and focus on the development of inhalation formulations which should be operational by the end of the fourth quarter of 2022.”
The expansion of the facility also includes the addition of a new containment system to allow the CDMO to handle a wider range of high potency compounds on all spray drying equipment from small to commercial scale. , including those with occupational exposure limits of 1 µm/m³.
Michael Grassberger, MD of Micro-Sphere, said, “Use of highly potent compounds is becoming more commonplace in the marketplace and today very few CDMOs offer this level of capability, especially when are combined with our experience and expertise.
“This facility expansion, coupled with our track record in the industry, enhances our ability to produce clinical and commercial products while providing a seamless experience for our customers around the world.
The company also confirmed its commitment to the biologics market with the successful renewal of its manufacturing license to add biologics to its compound portfolio.
From its GMP, SwissMedic and FDA approved facilities in Monteggio, Micro-Sphere’s team of experts supports customers in the United States, Europe, New Zealand and Asia with spray drying capabilities for development and the manufacture of potent and non-potent pharmaceuticals, with particular emphasis on inhalable dosage forms.