Micro-Sphere Expands HPAPI Capabilities at Swiss Site

Spray drying specialist and capsule filling service contract development and manufacturing organisation (CDMO) Micro-Sphere has invested over €5 million to expand its GMP manufacturing capabilities at its facility in Monteggio, Switzerland.

The investment sees the Swiss site benefit from infrastructure upgrades that include an increased production area for additional capsule filling equipment under containment, new lab space for inhalation testing and powder characterisation, and further warehouse and office space.

Matteo Berlusconi has been appointed as head of site at the facility and is responsible for overseeing the practical delivery of the company’s ambitious growth plans.

He said: “Since 2017 Micro-Sphere has invested almost €30 million to improve performance and gain efficiencies with upgrades to its facility and capabilities. In the last year alone, we have installed a second PSD-2 spray dryer to add more flexibility and capacity for both clinical and commercial manufacturing, two additional MG2 capsule filling machines to increase our low dosage capsule filling capabilities, and a Malvern 3000 in our QC laboratory for PSD measurement to match the technology of our customers.

“This latest investment is another example of how we continue to invest and grow to serve market requirements and work with our clients to improve drug development and delivery.

“We will continue to respond to industry demand and our ability to take on more complex and larger-scale projects at the site is already moving to the next level with a new R&D department to offer formulation development expertise and focused on inhalation formulation development expected to be operational by the end of Q4 2022.”

The facility expansion also includes the addition of a new containment system to allow the CDMO to handle a broader range of highly potent compounds on all spray drying equipment, from small- to commercial-scale, including those with occupational exposure limits of 1µm/m³.

Micro-Sphere MD Michael Grassberger, said: “The use of highly potent compounds is becoming increasingly common across the market and at present there are very few CDMOs offering this level of capability, especially when combined with our experience and expertise.

“This facility expansion, together with our track record in the industry, strengthens our ability to produce both clinical and commercial products whilst delivering a seamless experience to our customers across the globe.”

The firm also confirmed its commitment to the biologics market with the successful renewal of its Manufacturing Licence to add biologics to its compound portfolio.

From its GMP, SwissMedic and FDA approved facility in Monteggio, Micro-Sphere’s expert team supports customers in the US, 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.