With this approval, Farmabios can now offer manufacturing services with a high containment system up to occupation exposure band (OEB) 5, a cryogenic capacity up to -100°C and a fully automatized system with a distributed control system (DCS).

Axplora said that the new multipurpose facility is designed to produce HPAPI and steroid batches up to 300 kg thanks to a wide range of cutting-edge equipment including several reactors with a wide range capacity from 1,000 to 12,000 l, vertically connected to filter driers, horizontal centrifuges, biconic dryer and ancillary tanks for temporary process storage. Fully equipped isolators are also in place for loading and discharging starting materials, intermediates and final products.

“This major project to expand the Gropello Cairoli site demonstrates Axplora’s dynamism in our industrial investment strategy that we have been successfully deploying for several years,” says Paolo Perracino, director of the Gropello Cairoli site.

Gianpietro Roncoletta, project engineer at Farmabios, added: “Complex chemistry is our core competence at Gropello Cairoli site, enabling us to meet our customers’ needs with the manufacturing of HPAPIs and Steroids. This new cGMP production unit strengthens our offering and supports our position as a reliable and agile partner in the drug products value chain.”

We are so proud of this achievement, resulting from years of working together closely in the project team. My warm thanks to each person involved in this exciting journey. We started in 2019 with the construction of the building and while being slowed down by the COVID pandemic, we did not give up. This is evidence of our resilience on this site.”

Farmabios aims to get additional approvals for the now cGMP certified new production line by the end of this year to be fully operational.