APT1604 is a base-stable 600 Da peptidometic ligand coupled to a 6% cross-linked agarose matrix. APT1604 binds to Fc-fragment of monoclonal antibodies (mAb) and various immunoglobulin (IgG) subclasses. The interaction between protein and ligand has been suggested to result from mixed mode ionic – hydrophobic interactions, albeit with high selectivity for immunoglobulins. The main application area for APT1604 is purification of mAb from mammalian cell harvest, but it can also be used for purification of IgG from other sources. The…

In this work we present results with a novel high capacity Protein A medium prototype based on high flow agarose. The medium prototype was optimized for higher dynamic binding capacity (DBC) at long residence time. A 20–50% higher DBC was obtained compared to MabSelect SuRe™. DBC was independent of MAb concentration in the range 1–10 g/L. Optimization of elution conditions (pH and flow rate) was performed by design of experiments. A lifetime study for 100 purification cycles, performed with a…

Reliable analytical tools are valuable for economical process development, production, and batch release of vaccines. The current method recommended by the European Pharmacopoeia and WHO for determination of influenza virus titer ¬ single radial immunodiffusion assay (SRID) is straightforward and easy, but leaves plenty of room for improvement when it comes to assay variability and speed of analysis. In addition to having low sensitivity and precision, the method is both time-consuming and quite labor-intensive. In this study a Biacore™ assay…

With increasing use of single-use, disposable fluid processing systems, concerns of mixing arise in processes such as protein concentration, clarification and diafiltration. For some operating conditions of flow rate, solution viscosity or flow path configurations, protein solutions may become stratified in vertically-oriented hanging bags. This can cause decreased efficiency in cross flow applications. In this study, we modeled a stratified solution and tested the influence of these various operating conditions using ReadyCircuit* 2-D pillow bags. Even with viscous materials, flow…

Much attention has been given to ion exchange (IEX) media as a means to improve productivity as a result of increasing demand for higher efficiency on the downstream process. Until recently, strain optimisation for high productivity and upstream purification were the bottlenecks for most bio-processes. However, with the progress made in recent years, titers in fermentation processes have increased significantly. Obviously, this increased volumetric productivity will help reducing the cost of goods, but it also has an impact on the…