Cosmos – that’s the name of the production site launched in July 2021 in Lugano – has already obtained important authorisations and has started its production activity in three departments: pre-filled syringes (PFS), single dose strips for thyroid hormones and oral solids (hard capsules, tablets and an intermediate of syrup).
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‘Cosmos’: Technology, Efficiency and Sustainability
THE VISION BEHIND THE NEW FACTORY
The new site embodies the realisation of a far-sighted strategy: centralising the activities and IBSA offices, which over the last decades have been distributed throughout the Lugano area (with the offices of Lamone, Cadempino, Manno and Collina d’Oro), while accompanying the extraordinary growth that IBSA has been experiencing in recent years.
In addition to centralising operations, the new plant – which is part of the larger project of the CorPharma district – will also allow for the expansion of production, an aspect that inevitably required new spaces, as well as the adoption of modern and cutting edge technologies. Precisely for this reason, Cosmos is equipped with the best technological solutions, to be always looking at development from a green and sustainability perspective.
PRODUCTION OF PRE-FILLED SYRINGES AUTHORISED FOR ALL EUROPEAN COUNTRIES
When it comes to production plants, in the pharmaceutical industry two types of approvals are required, one at the production site level (manufacturing authorisation and GMP) and one for the registration dossier of the drug or medical device.
The department dedicated to the production of pre-filled syringes had already obtained the manufacturing authorisation from the local authorities (Swissmedic), at the end of 2021. Following this authorisation, on March 16 the Notified Body EUROFINS conducted a surveillance inspection for the production of IALURIL, a medical device that – once administered intravesically – helps restore the urothelium.
The audit was successful: Cosmos’ PFS department is now authorised to produce IALURIL in pre-filled syringes in all European countries, as well as in UK and Switzerland, where the product is currently on the market. The next step will be to obtain authorisations for non-European countries, where the product is already registered, but where the new production site is yet to be authorised, such as Korea, Australia, Colombia and Vietnam.
In the words of IBSA’s Regulatory Affairs team: “Having obtained the authorisation to centralise the production of IALURIL for all of Europe at the Cosmos site is a source of great pride. Cosmos is a very nice and advanced plant, from both a technological and a sustainability perspective. Now, our commitment is aimed at having our new site recognised and authorised even outside Europe”.
MORE TECHNOLOGIES, MORE EFFICIENCY, MORE SUSTAINABILITY
This recent approval is a further step towards the centralisation of the activities and operations that IBSA aims to achieve. Until a few months ago, before the approval of the PFS department of Cosmos, the production and finalisation of pre-filled syringes were divided between the Swiss plant in Massagno and the Italian one in Lodi. Indeed, production would be initiated in the Massagno plant but – since this site does not have the necessary equipment for terminal sterilisation – the product had to be shipped to Lodi and, finally, returned to Switzerland for inspection and secondary packaging.
As the Quality Assurance department, which closely followed the project, told us: “This is a big step forward for IBSA, a step of which we are very proud. With the production of IALURIL taking place entirely in Switzerland, in the Cosmos plant, the whole process can now be managed on site. In addition to centralising activities, this makes it also possible to reduce the movement of goods and products in their intermediate manufacturing stages, thus significantly reducing CO2 emissions”.