PolyPeptide Malmö, Sweden
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 600L. The Malmö facility is the ideal site for very large scale GMP manufacturing for both SPPS and LPPS projects.
The facility offers both high and low 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 (up to 288 kg ice capacity).
The Malmö facility has successfully undergone several pre-approval and routine site inspection by the US FDA. The latest inspection took place in 2016. After passed inspections, GMP certificates are issued by regulatory authorities, including the Swedish MPA and the Japanese PMDA.