Orbicell® Technology Overview

APL’s proprietary technology platform is marketed under the registered trade name Orbicell®.

Orbicell® Bioresins are activated with special chemistries that bind valuable biological materials. These Bioresins serve as physical carriers of covalently attached ligands which function as specific hooks that specifically bind target biomolecules from biological fluids. During purification processes, highly valuable biomaterials (i.e. monoclonal antibodies, tagged recombinant fusion proteins, ect.) found at low concentrations in a sea of contaminants, are recovered by the ligands in high yields, and with purities that are very close to standards required for therapeutic applications.

In a standard tangential flow ultra filtration system molecules of varying sizes are circulated through the filters. Molecules larger than the filter pore size, are retained within the tangential flow loop, circulating continuously. Molecules smaller than the filter pore size, pass through the filter and exit the flow system. Therefore, the tangential flow system separates molecules based only on their size. Consequently, a tangential flow ultra filtration process is hardly adequate to purify by itself a specific biomolecules and yield a purified product. To do this, such a system must incorporate into the process an affinity separation matrix, such as Orbicell® Affinity Bioresins.

The Orbicell® Affinity Bioresins purify specific biomolecules by an affinity process to yield a purified product. The Orbicell® Process methodology is based on a simple fact that individual beads, when larger than the pores of a micro filtration membrane, are always kept within the flow system, be that a tangential flow or some other filtration system or, alternatively, continuous centrifuge system. Therefore, when affinity ligands (“hooks”) on the surface of Orbicell® beads capture target biomolecules, only the beads are retained circulating within the system, while either the contaminants or the products can be washed out. In APL’s affinity separation process, Orbicell® Affinity Bioresin Platform is designed to exclusively and reversibly capture selected target molecules with their specific binding hooks, thus enabling an effective capture, washing, and release of purified biomolecules. The unwanted biomaterial, present in the solution, passes during the washing cycle through the pores of a filter or is washed out with the supernatant of an alternative continuous centrifuge. When the contaminants are completely removed, changing the binding conditions (pH, salt concentration, ect.) will release the bio product molecules from the affinity resin into the solution. The resulting eluate is subsequently concentrated by ultra filtration process, yielding a highly purified product in high yield.