Contract development and manufacturing organisation (CDMO) Micro-Sphere has invested more than €1.5 million at its plant in Switzerland to expand its offering in encapsulation for inhalation products.
Boosting its existing automatic capsule filling equipment Micro-Sphere has taken delivery of and commissioned a further two MG2 capsule filling machines to increase its low dosage filling capabilities to more than 100,000 capsules per hour.
Michael Grassberger, CEO, Micro-Sphere said: “Micro-Sphere is widely recognized for its expertise in Dry Powder Inhalation encapsulation services of difficult powder formulations. The new machinery will offer high quality products, reduced production times and cost savings for customers who want real commercial benefit.
“This investment is the result of increasing client demand. Added to our existing Harro Höfliger drum dosing equipment, the new MG2 Planeta dosator system means we are one of the few CDMOs in the world to offer these two important commercial size filling techniques under one roof and bridge the gap from development to commercial scale on both techniques for DPIs (dry powder inhalers).
“Both systems are designed for low-dosage filling and have an inline control unit (100% net weight check), FlexaLab (up to 3’000cps/hr.) that is ideal for R&D purposes and small clinical batches, and Planeta (up to 100’000cps/hr) which is scalable for medium-large batch productions. This brings more flexibility for our customers and a best-in-class approach.”
Situated in a new dedicated cleanroom at Micro-Sphere’s EU-GMP, FDA and SwissMedic approved facility near Lugano in Ticino, the MG2 equipment is in an area of controlled temperature and relative humidity of <20%, has a production capability of more than 100,000 cps/hour and increases the CDMO’s manufacturing capacity to up to 600 million capsules per year.
Alongside the MG2 Planeta machine, and for DPIs containing multiple doses, the company has also invested in increasing their containment level (OEB5) and in its DPI testing capabilities with additional Dosage Unit Sampling Apparatus (DUSA) and Next Generation Impactor (NGI).
“This investment sends a strong signal to our customers and partners by increasing our market competitiveness,” added Michael. “As the pharmaceutical industry is under increasing pressure to develop new drugs faster, we are committed to investing in the production capacity, technology and quality systems necessary to continue delivering high-quality, innovative solutions to our customers.”
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 GMP, SwissMedic and FDA approved facility near Lugano, Ticino, 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.
