True Moving Bed Chromatography (Tmbc)

Archimedes is a novel new continuous purification system (1) for purification from large volumes and concentrations of product that achieve product specifications. This new system eliminates the bottleneck caused by packed columns but retains chromatographic purification resin chemistry allowing ionic, size, affinity, and hydrophobic interaction chromatography to allow achievement of product specifications. In this system resin slurry is transported continuously through a pipe with a screw driver and a peristaltic pump. During this movement, the resin is sequentially contacted by the equilibration, load, wash, elution, and strip buffers before being continuously recycled. Continuous elution is caused by adjustment of the conductivity of the elution buffer to a conductivity that enables elution of the product at controlled concentrations and in the presence of polysorbates or multiple excipients. Each buffer is adjusted to an appropriate conductivity similar to elution with a step gradient of conductivity. This method results in improved manufacturing productivity (2) (3)because it continuously purifies. The system also offers improved scalability, improved resolution, faster operation, improved purity, and a smaller footprint as well as reduction of buffer utilization and resin requirements. Substantial savings in manpower, raw material, and capital costs accrue. These characteristics make it ideal for the purification of a perfused culture resulting in a fully continuous manufacturing process. Use of this system will convert conventional antiquated batch-wise manufacturing technology to modern continuous technology increasing manufacturing productivity and reducing manufacturing costs.

Keywords: Simulated Moving Bed, Chromatography, SMBC, Continuous Biopharmaceutical Manufacture, Manufacturing Cost Archimedes.