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 16L-600 L (SPPS reactor) and 215L-1500L (LPPS reactor) working volumes may be smaller. 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 (RPC-columns) and 30-100 cm (IEC columns/low pressure columns) some are dedicated to specific products. 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 inspections. The latest inspection by the Swedish MPA took place in 2022 and the current GMP certificate was issued. The site is also inspected and approved by Japanese MPDA and US FDA.