Switzerland-based contract development and manufacturing organisation (CDMO) Micro-Sphere has successfully completed the Swissmedic inspection of its expanded facility, resulting in the renewal of its GMP approved status and increased manufacturing capacity.
The Swissmedic approval will allow Micro-Sphere to provide larger capacity output, with the CDMO in a position to supply pharma grade spray dried powders at 10s of MT per year and manufacture up to 500 million capsules per year.
The formal audit was carried out at Micro-Sphere’s state-of-the-art facility near Lugano, in Ticino, due to recent expansion as part of a 21 million CHF (€19 million) investment.
Swissmedic is the Swiss national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, and a license is needed to manufacture medicinal products in the country.
“Our facility met the expectations related to GMP and quality for spray drying and manufacturing services to support our customers. We are satisfied with the result achieved” said Ms. Liana Meneghin, Qualified Person (QP) at Micro-Sphere.
Micro-Sphere will continue to work across all the markets where Swissmedic GMP certification is recognised, including Europe and Canada, and intends to increase its client portfolio with its greater capacity.
“Our company is growing and expanding its operations. We have invested a significant amount of time and resource into gaining Swissmedic approval because a positive audit is a critical component of our expansion process.
“We remain deeply committed to excellence and further growth, and quality is crucial to our success and our customers’ satisfaction,” said Stefano Console, Managing Director at Micro-Sphere.
The approval is the next step in Micro-Sphere’s investment into expanding its GMP manufacturing capabilities at its facility in Switzerland and comes in response to increased demand for spray drying from companies ranging from big pharma to small virtual firms.
From its GMP, SwissMedic and FDA approved facility, 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.