Ardena’s drug substance team comprises over 110 people dedicated to support our customers with all their needs encountered during the development of new drug substances. This comprises, solid state research, process and analytical development, manufacture of clinical scale and small commercial scale active pharmaceutical ingredients, and release and stability testing.
We have a dedicated and experienced development team supporting process development, analytical development, process safety investigations, and solid state research.
Our process development labs house reactors from 0.5 L up to 20L, parallel reactor equipment, and autoclaves from 10mL up to 5L. Our process safety lab is equipped with a DSC and RC1.
Our analytical labs support development, QC and stability testing of drug substances, and comprise a full array of analytical equipment, including NMR, UPLC, HPLC, LC-MS, GC, GC-HS, IR, Raman, XRPD, single crystal X-ray diffraction, Malvern nanosizer, GPC, TGA-MS, AAS, and coulometric Karl Fischer.
Our production facilities include two state of the art GMP pilot plants, one in Oss (The Netherlands) and one in Sodertalje (Sweden). The plants contain fully segregated manufacturing suites, LAF weighing booths and grade C cleanroom environments.
Our GMP manufacturing equipment consists of reactors from 1L up to 1000L (HC and GLS), autoclave reactors, liquid, slurry, and powder dosing devices, agitated work up tanks (700 L), filters, filter dryers, stoves, 50L and 100L rotary evaporators, stainless steel chromatography columns, preparative HPLC systems and VTA short path distillation equipment.