The, Swedish site in Malmö is a 100,000 square foot (~10,000 sq. meters) facility, equipped with 6000 liters of total reactor capacity for solution phase manufacturing (with reactors from 150L to 1500L), and solid phase reactors up to 280L. The Malmö facility is the ideal site for very large scale GMP manufacturing for both SPPS and LPPS projects.
The facility offers high pressure columns used for large-scale purification with internal diameters ranging from 20 to 60 cm. Isolation of peptides at large-scale is achieved with multiple large tray lyophilizers (200 kg ice capacity).
The Malmö facility has successfully undergone 6 pre-approval inspections by the US FDA, and an additional routine site inspection by the US FDA. The last inspection took place in 2013.