Technology
Direct Capture™
Direct Capture™ is a scalable method developed by Sterogene Bioseparations for the rapid purification of a target biomolecule from unclarified feed streams without having to filter, centrifuge, or pre-treat the feed stream or load on a packed bed chromatography column. Direct Capture™ purification speeds recovery of the target biomolecule, preserves biological activity and reduces potential loss.
Recovery of biomolecules directly from fermentation broth or unclarified feed streams is more technically difficult than one would predict. Sterogene Bioseparations has developed a process that is both efficient and scalable. We refer to it as Direct Capture™.
Direct Capture™ utilizes the inter-sphere and interstitial spaces between larger particles of CellthruTM BigBeads (particle sizes between 200 to 300 µm, 300-500µm and 500-1000 µm, dependent on the application) to allow cells, cellular debris, and residues to pass unhindered through the resin bed, while active ligands capture and bind the desired biomolecule. The resin is then washed to remove any trapped particulates before elution. Because there is a loss of recoverable protein with each unit step such as filtration or centrifugation, streamlining the downstream process using our Direct Capture Technology in a packed column greatly improves overall yield and lowers the cost.
Uniflow
Uniflow 4 is a 4%, 60-160 micron agarose medium, suitable for low pressure and low flow rate gel filtration and affinity chromatography. Uniflow 4 is ideal for immobilizing biologically active substances since it displays low levels of non-specific binding.
UltraFlow Extracorporeal Devices
Extracorporeal devices are mechanical organs used in blood purification such as apheresis, hemodialysis, hemofiltration, plasma-pheresis, or extracorporeal membrane oxygenation. Extracorporeal affinity adsorption devices, which are aimed at the removal of substantial amounts of compounds that participate in the pathogenesis of diseases in humans, provide effective therapeutic intervention. Several of these devices are on the market and are used successfully. New technologies such as antibody-coated adsorbents and microsphere-based detoxification are being introduced that are aimed at specific therapeutic targets. These devices must possess certain requirements including: anti-allergenic, anti-carcinogenic, resistance to microorganisms, antibacterial, non-toxic, and the ability to be sterilized. The function and performance of these devices depend on the adsorbent used.
Sterogene has developed special particles and surface chemistries specifically address these requirements. Our particles have been characterized extensively for TOC and other leachables. They are nontoxic, autoclavable, and are already a part of an FDA-approved device.
Custom Resins
As a manufacturer of chromatography resins, Sterogene Bioseparations has control over every step of the chromatography resin manufacturing process. We can control particle size, pore size, and cross-linking chemistry. We can give you the choice and substitution level of active groups and ligands. Sterogene’s scientists can provide our expertise to assist you with customization of our standard products to make an optimal resin for your specific application.
Sterogene can provide application specific-customized resins that are cost-effective and can provide documentation to assist in the approval of the process with regulatory agencies.
Customizations
Customization of a resin isn’t just about the ligand and ligand density.
| Application | Straightforward purification? Contaminant removal? In-line? Off-line? Extracorporal? |
| Feed stream | Clarified or unclarified? |
| Flow Rate | How will flow rate affect the process? |
| Target molecule | What am I trying to purify or remove? |
| Non-specific binding | Will “impurities” lower the binding of my desired target? |
| Particle size | How could particle size affect the purification? |
| Porosity | How may I use particle porosity to my advantage? |
| Immobilization chemistry | Which chemistry will give me the best performance? |
| Immobilization chemistry density | How do I ensure I don’t get “overloading” of the resin? |
| Ligand density | Is my ligand very expensive? Can I achieve the same or better results with a lower ligand density? |
| Resin life-time | Will I use the resin once or for multiple purification cycles? |
| Regeneration | How do I want to / need to regenerate and clean the resin |