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Our Technology

Our Technology

PlasmaCap EBA™ is Therapure Biologics’ innovative expanded bed adsorption (EBA) technology for plasma protein capture.

It was developed by a dedicated team of experts to extract valuable plasma proteins directly from plasma or fractionated plasma materials by providing:

  • Efficient protein capture
  • High plasma protein capture yields
  • High purity plasma proteins

Watch and Learn

Watch this video learn about PlasmaCap EBA™ in detail.

Therapure Biologics: PlasmaCap EBA™ and Plasma Protein Capture

PlasmaCap EBA™ will help provide a stable supply of high quality plasma proteins to the North American market. Our initial focus is on three important plasma proteins: intravenous immunoglobulin (IVIG), albumin, and alpha-1 antitrypsin (AAT) which are established products in the plasma protein industry with growing demand. Using our extensive knowledge of plasma proteins and working with key industry players, we have developed a program to launch these products to address the needs of the market.

Learn more about our pipeline of plasma proteins.

Learn more about how PlasmaCap EBA™ technology captures plasma proteins.

Innovative Features of PlasmaCap EBA™

In addition to the ability to efficiently capture plasma proteins at high yields and purities, PlasmaCap EBA™ is an elegant technology that was designed with innovative features aimed at resolving practical issues with conventional chromatography.

1. Flexible choice of starting material

  • Handles common buffers and plasma sources with high particulate and viscosity allowing for manufacturing flexibility

2. Even distribution of material flow

  • Gentle rotation of fluidizer creates even distribution of material flow to increase ligand-protein interaction for optimal capture yields

3. Proprietary adsorbents for optimal protein capture

  • High density (3.0-3.5 g/mL) tungsten-carbide agarose beads minimize adsorbent bed expansion requirements, reducing buffer usage and column sizes
  • Adsorbents consist of varying size distribution of beads (40-350 µm) allowing for an expanded bed with optimized surface area for plasma protein capture
  • Beads can be cross-linked to conventional ligands including:
    • Affinity ligands
    • Ion-exchange ligands
    • Mixed-mode ligands
    • Metal-chelating ligands
  • Adsorbent manufacture is ISO 9001 certified
  • Proprietary adsorbents designed to facilitate regulatory approval of drug products:
    • Adsorbent materials are generally considered safe for biopharmaceutical manufacturing
    • Adsorbents have been documented to have no leachables or extractables

4. Optimal expanded bed adsorption for efficient plasma protein capture

  • Material flow generates stable expanded adsorbent bed based on bead size (largest at bottom, smallest at top) keeping operations simple
  • Near plug-flow material movement reduces back mixing and convection currents minimizing residence time, reducing cycle time and operating costs
  • Void space in expanded adsorbent bed allows particulates, precipitates, and air bubbles to pass through with minimal effect on chromatography operations

5. High throughput plasma protein capture and elute

  • Minimal pressure drop along the column; material throughput is limited by rates of ligand-protein interactions which allows high material throughput, reducing cycle time and operating costs

Additional Properties

  • Whole system, including column and beads, can be efficiently cleaned in place with 1 M sodium hydroxide at high temperatures
  • Column and process is scalable from development scale to commercial scale

Capture Multiple Plasma Proteins using
PlasmaCap EBA™

To optimize the therapeutic benefit derived from donor plasma, Therapure Biologics’ patented manufacturing process passes human pooled plasma through sequential PlasmaCap EBA™ chromatography columns.

Each column is designed with proprietary adsorbent beads that selectively extract plasma proteins with optimal protein binding, to give enhanced product yield and purity for proteins used in established therapies. PlasmaCap EBA™ also has the potential to produce novel therapeutic proteins.

The gentle rotation of the proprietary fluidizer creates even material distribution for maximum target-protein binding.

Unbound proteins flow through the column, retaining their structure, allowing this flow through to be processed on sequential PlasmaCap EBA™ chromatography columns.

Utilizing the flexibility of the PlasmaCap EBA™ technology, our scientists have generated and tested protocols for capturing plasma proteins from materials commonly available including:

  • Fresh frozen plasma
  • Cryo-poor plasma
  • Cohn supernatants
  • Cohn fractions

From these materials, this technology is able to capture many proteins including:

  • Immunoglobulin G (IgG)
  • Human Serum Albumin (HSA)
  • Alpha-1 Antitrypsin (AAT or A1AT)
  • Factor VIII (FVIII)
  • von Willebrand Factor (vWF)
  • Fibrinogen
  • Prothrombin Complex Concentrate (PCC)
  • Antithrombin III (AT or ATIII)
  • Transferrin (Tfn)

To learn more about how plasma protein manufacturers and other biomanufacturing organizations can take advantage of PlasmaCap EBA™, please contact us.

It has shown promising results for yielding more therapies of high quality and purity from the precious supply of plasma.

Customize PlasmaCap EBA™ for your process

The market for plasma proteins continues to expand due to a growing patient base for current products and novel plasma protein products. There is increasing opportunity to capture more value out of each unit of plasma or fractionated plasma material. Whether you are a plasma protein manufacturer or a biomanufacturing organization, the PlasmaCap EBA™ technology can be customized to capture a wide range of plasma proteins.

Our development team can work with you to develop a custom process using the PlasmaCap EBA™ technology and:

  • Manufacture customized high density adsorbents
  • Optimize adsorbents to maximize plasma protein capture
  • Perform pilot runs to validate a custom process
  • Optimize EBA parameters for efficient plasma protein capture

The PlasmaCap EBA™ technology was designed to facilitate drug product regulatory approval:

  • Technology was designed to comply with GMPs
  • Adsorbent materials are generally considered safe for biopharmaceutical manufacturing
  • Adsorbents have been documented to have no leachables or extractables

PlasmaCap EBA™ technology enhances cost-effectiveness. It reduces operational involvement in capturing plasma proteins and can yield more therapies of high quality and purity from the prescious supply of plasma, unlocking plasma’s potential to improve life.

To learn more about how plasma protein manufacturers and other biomanufacturing organizations can take advantage of PlasmaCap EBA™, please contact us.

Customize PlasmaCap EBA™ for your process

Research Articles on EBA Technology

Capture of human Fab fragments by expanded bed adsorption with a mixed mode adsorbent.

A novel core fractionation process of human plasma by expanded bed adsorption chromatography

Simplified and more robust EBA processes by elution in expanded bed mode

Expanded bed adsorption in the purification of biomolecules

Capture of human Fab fragments by expanded bed adsorption
with a mixed mode adsorbent.

Hansen MB., Lihme A., Spitali M., King D. Bioseperation. 1991; 192(1):64-9.

A novel group of mixed mode adsorbents has been developed for purification of monoclonal and polyclonal antibodies from a broad range of raw materials such as hybridoma cell culture, ascites fluid, animal sera, milk, whey and egg yolk. The aim of this study was to determine whether such mixed mode adsorbents were also useful for the recovery of recombinant proteins from microbial feedstocks. This paper describes the performance of one of these adsorbents for expanded bed capture of a human Fab fragment from recombinant E. Coli cell extracts.

It is concluded that the mixed mode adsorbent binds the Fab fragment efficiently from crude extracts without any requirement for preconditioning the extract by for example de-salting or dilution. The capacity of the mixed mode adsorbent is approx. 12 mg Fab/ml matrix.

The novel mixed mode adsorbent can be useful during production of highly purified Fab fragments as the first step in a purification scheme. In this respect the mixed mode adsorbent is advantageous over alternative commercially available ion-exchange materials which require pre-conditioning of cell extract for Fab' capture. Together with the concentration and clarification effect a significant enrichment of the Fab fragment is obtained in one single high yield operation.

A novel core fractionation process of human plasma by expanded bed adsorption chromatography

Lihme A., Hansen M., Andersen IV., Burnouf T. Anal. Biochem. 2010; 399(1):102-9.

Current plasma fractionation technology combines ethanol precipitation with packed bed chromatography. We have developed a novel core fractionation process comprising five expanded bed adsorption (EBA) chromatographic steps on high-density modified agarose/tungsten carbide beads. Plasma was first chromatographed on two diethyl amino-ethyl (DEAE)-tungsten carbide agarose adsorbents (respective mean particle diameters of d(v)(0.5)=190 and 37 microm) to isolate at 50 to 80% recovery a fraction containing 4 to 7 IU/ml factor II (FII), factor IX (FIX), and factor X (FX) (specific activity >1 IU/mg) and another enriched in FVIII and von Willebrand factor (vWF) (approximately 1 IU/ml and 0.6 IU/mg, respectively). The flow-through was adsorbed on 4% agarose-10% tungsten carbide beads coupled with an acidic mixed-mode ligand to isolate an 80% pure immunoglobulin G (IgG) at a 93% step recovery. A highly purified alpha1-antitrypsin was isolated at 95% step recovery by adsorbing the flow-through on 4% epoxy-crosslinked agarose-10% tungsten carbide adsorbent material coupled with a cationic ligand. Isolation of 98% pure albumin was achieved at a 99% step recovery by pH 4.5 adsorption of the flow through on 6% agarose-10% tungsten carbide beads coupled with an acidic mixed-mode ligand. EBA may represent a feasible alternative core plasma fractionation tool.

Simplified and more robust EBA processes by elution in
expanded bed mode

Lihme A., Zafirakos E., Hansen M., Olander M. Bioseperation. 1999; 8(1-5):93-7.

This paper illustrates the feasibility of eluting EBA columns in the expanded bed mode as an alternative to the generally used method of packed bed elution. It is shown that at linear flow rates of 1-3 cm/min the difference in total elution volume between expanded bed elution and packed bed elution is less than 20%. It is suggested that expanded bed elution offers a range of significant advantages, while the drawbacks will be insignificant in most applications. The key to the success of this method seems to be the use of EBA matrices with a relatively low degree of expansion (i.e. a high density) at the linear flow rates employed for elution of bound product.

Expanded bed adsorption in the purification of biomolecules

Lihme, A., Hansen M., Olander M., Zafirakos E. Downstream Processing of Proteins, Methods in Biotechnology Volume 9, 2000; Chapter 10:121-139.

Stabilized fluid bed adsorption also phrased, expanded bed adsorption (EBA), is a recently introduced “whole broth processing” technique that enables the isolation of biomolecules(e.g., proteins and plasmids) directly from crude raw materials such as fermentation broth or extracts from natural sources. The use of EBA, as an alternative to the traditional methods, may in many instances combine the effects of centrifugation, filtration, concentration and purification into one step and hereby save time, increase yields, and cut down processing costs. EBA is a new technology that - given room for proper adaptations - may be successfully applied within a number of different industries ranging from the highly sophisticated and highly regulated pharmaceutical industry, through the production of industrial specialty enzymes, to the low-cost high-volume applications characteristic for the food industry. Even certain applications within the field of waste water treatment and valorization of waste materials may be envisioned.