On top of our broad capabilities, expertise, and track record in drug substance development, we have the following highlights that differentiate Ardena’s offering from other drug substance manufacturers.
Ardena offers a wide array of chromatographic purification techniques. While the goal of every process chemist is to eliminate chromatographic purification steps, this often if not possible in early clinical development. In order to enable delivery of multi-kg quantities of high quality drug substance, chromatographic purification of intermediates or final drug substance may be required.
Ardena has capabilities to perform gravity chromatography with batch size up to 20 kg/run. For more complex purifications Ardena offers preparative HPLC. We employ 4 prep-HPLC systems (Novasep and Hypersep) with 15 cm and 20 cm columns. We have huge experience in the purification of complex mixtures from synthesis or derived from natural products.
Ion Exchange Chromatography
For charged (bio)molecules Ion Exchange Chromatographic (IEC) is a highly efficient purification technique. Arden has expertise in using IEC for the purification of mono- or poly-sulfonate, phosphate, carboxylate derivatives of carbohydrates, cyclodextrines and other small and large molecules.
We run IEC under GMP using GE Bioprocess system with columns up to 20 cm.
Ardena has capacity for ultra- and nanofiltration of small molecules, (bio)conjugates, polymers, and nano- or micro-particles. This enables us to remove organic impurities and solvents, salts, and to carry out buffer exchanges for your product.
Short path distillation
Ardena offers short path distillation for the purification of very high boiling and thermally labile compounds. We perform short path distillation to meet research and GMP requirements. We have capacity to purify up to 100 kg per 24 hours.
High potent drug substance manufacture
Ardena’s drug substance unit has capabilities and expertise in the manufacture of highly potent drug substance, including steroids. Our production facility has containment capabilities that comply with Occupational Exposure Band C (0.1-1 mg/m3) requirements.
Ardena offers comprehensive peptide development and production capabilities. Our GMP facilities comprise of manufacturing labs for peptide synthesis and purification, LAF hood, and a grade C cleanroom.
We also provide a range of peptide analysis and characterisation technologies that ensure you have full characterisation information about your drug substances.