We deliver scalable and robust GMP-compliant purification processes for recombinant proteins.
Our expertise in downstream processing allows us to develop improved or completely novel purification processes. Hereto, we typically adhere to Design of Experiments (DoE) and Quality by Design (QbD) tools to efficiently anchor purification steps and monitor the key process parameters for scale-up.
We are well-equipped to perform high-throughput screenings. Depending on the molecule of interest we use a wide range of diverse clarification filters and chromatography resins. , Using these, we can assess a variety of properties , such as affinity, pseudo affinity, ion-exchange, hydrophobic interaction, size-exclusion or mixed mode, to quickly test rapid clarification, binding and elution properties of the protein of interest. In addition, we have developed various processes including TFF flat screens or hollow fiber membranes for ultrafiltration/diafiltration (UF/DF), enzymatic treatments for DNA digestion, nanofiltration for viral clearance and sterile filtrations.
For small scale cultures, up to 1 L, product can be batch-wise clarified by centrifugation, purified on appropriate pre-packed columns and be subjected to concentration/diafiltration by ultracentrifuge membrane devices to support feasibility and proof of concept studies.
For larger scale cultures, up to 200 L product per run can be clarified using single-use filters as pre-defined during the earlier development phase. The proteins can be further purified by chromatography using the ÄKTA™ pure 25 automated purification system, suitable for process design and purification up to a few milligrams of protein in a relatively short time and cost-effective manner.
Using the ÄKTA™ pilot systems we scale up the chromatography process to confirm the scalability of the designed process and producing for instance 50 g of the protein of interest per batch. The material generated is suitable for further characterization and/or toxicology studies. Finally, a UF/DF process step is designed to concentrate, diafiltrate and formulate the intermediate and/or the final product. Alternatively, formulation is performed using desalting chromatography.