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Modernize plasma fractionation for higher yield and purity
Global demand for plasma-derived therapeutics, including Intravenous Immunoglobulin (IVIG), albumin, coagulation factors, and protease inhibitors, continues to grow, while the supply of human source plasma remains constrained. Improving the recovery of therapeutic protein from each liter processed during blood plasma fractionation is therefore critical. Selective chromatography technologies, such as affinity chromatography, support higher yield and purity per liter, helping manufacturers extract greater therapeutic value from available plasma.
Challenges in the plasma fractionation process
Traditional precipitation-based workflows introduce multiple processing steps, each contributing to cumulative yield loss across the purification process. Chromatography solutions, including chromatography resins, designed for plasma protein purification, can be scaled from process development to commercial manufacturing while supporting regulatory documentation requirements. High-performance affinity chromatography resins address these constraints at the capture step, while ion exchange chromatography resins help address impurities in subsequent steps.
Affinity capture for plasma-derived proteins
The CaptureSelect affinity chromatography resin portfolio addresses the selectivity challenges associated with plasma protein purification. CaptureSelect resins use VHH single-domain antibody fragments that bind target plasma proteins directly from complex source materials, including plasma intermediates. This selectivity enables high purity during the capture step and can reduce the number of downstream purification steps. The portfolio supports purification of major plasma protein targets, including IgG, human serum albumin, alpha-1 antitrypsin, Factor X, and C1 inhibitors, as well as a pipeline of affinity ligands and resins in development for various plasma protein targets. Ligands are produced through an animal origin-free (AOF) process.
- IgG purification from plasma
- Albumin, AAT, Factor X, and C1 inhibitor capture
CaptureSelect FcXP Affinity Matrix and POROS CaptureSelect FcXP Affinity Resin are the two format options for IgG capture from plasma. Both resin formats share the CaptureSelect FcXP ligand which binds to the CH3 domain of human IgG, enabling capture directly from complex plasma feedstocks. The ligand binds to four human IgG subclasses (IgG1, IgG2, IgG3, and IgG4), preserving the natural subclass distribution critical for the clinical efficacy of IVIG products.
POROS CaptureSelect FcXP combines the FcXP ligand with a rigid POROS bead structure that supports predictable pressure-flow characteristics and a broad operating range suitable for large-scale purification.
The CaptureSelect portfolio addresses the major high-value plasma protein targets beyond IgG:
- CaptureSelect Human Albumin Affinity Matrix: Designed for high-selectivity, single-step purification of human serum albumin (HSA) from plasma. High yield and purity are achievable in one step.
- CaptureSelect AAT-XL Affinity Matrix: Intended for purification of alpha-1 antitrypsin (AAT) from plasma and recombinant sources.
- CaptureSelect Factor X Affinity Matrix: Designed for purification of human Factor X from plasma and recombinant sources.
- POROS CaptureSelect C1-InhXL Affinity Resin: Designed for purification of human C1 esterase inhibitor.
Advantages of affinity chromatography for plasma proteins
The CaptureSelect affinity platform offers three core technical advantages across plasma protein targets:
- High selectivity: Selective ligand binding supports efficient capture from complex plasma matrices.
- Mild elution conditions: Elution conditions help maintain biological activity without requiring harsh pH conditions or chaotropic agents.
- Efficient clearance of impurities: Selective binding supports the reduction of non-target plasma proteins and process-related impurities.
Polishing steps in the plasma protein purification process
Following affinity capture, additional polishing steps help reduce aggregates, product variants, endotoxins, and residual plasma-derived impurities. Ion exchange chromatography (IEX) is commonly used during plasma protein purification to further improve product purity and safety.
POROS resins feature high binding capacity, high resolution, and a rigid poly(styrene-divinylbenzene) backbone that tolerates high-viscosity feedstocks common in plasma processing. Chemical stability under stringent cleaning-in-place (CIP) regimes supports the cleaning requirements of commercial manufacturing programs.
Ion exchange resins in plasma protein purification
Ion exchange chromatography separates proteins based on differences in surface charge and can operate in bind-elute or flow-through modes. The following resins support plasma protein polishing applications:
Anion exchange (AEX) resins:
- POROS 50 HQ Strong Anion Exchange Resin: Mixed amine, large pore, suited for plasma proteins polishing in bind/elute or flow/through mode.
- POROS XQ Strong Anion Exchange Resin: Quaternary amine, medium pore, suited for plasma proteins polishing in bind/elute or flow/through mode.
Cation exchange (CEX) resins:
- POROS 50 HS Strong Cation Exchange Resin: High-capacity strong cation exchanger suited for plasma protein polish
- POROS XS Strong Cation Exchange Resin: High-capacity strong cation exchanger, salt tolerant, suited for plasma protein polish.
Quality, supply continuity, and manufacturing support
Selecting a chromatography resin supplier involves considerations of supply security, manufacturing quality, and regulatory documentation. CaptureSelect affinity resins and POROS chromatography resins are manufactured in ISO-certified facilities that support quality and regulatory documentation requirements. Dual-site production capabilities help support supply continuity for commercial manufacturing programs.
Frequently asked questions
CaptureSelect FcXP Affinity Matrix and POROS CaptureSelect FcXP Affinity Resin are designed for purification of IgG directly from complex plasma feedstocks. Both bind the CH3 domain of human IgG and capture four human IgG subclasses (IgG1, IgG2, IgG3, and IgG4), preserving the natural subclass distribution important for the clinical efficacy of IVIG products. A single affinity capture step can achieve high purity and yield. This capture step can help reduce the number of downstream polishing steps required.
CaptureSelect and POROS resins are available in screening and process development formats, as well as bulk quantities for pilot and commercial manufacturing using the same resin chemistry and ligand technology.
Process development tools include 96 well GoPure screening plates for rapid resin evaluation and static binding experiments, Robocolumns for high-throughput condition screening, and GoPure or MiniChrom™ columns for small-scale process development. Leakage ELISA assays are also available to quantify affinity ligand leakage during process characterization.
Additional bioprocessing resources
Bioprocessing resources
For research and development use only in support of FDA-regulated end uses. Not for diagnostic use or direct administration to humans or animals.