Thermo Fisher Scientific

POROS™ CaptureSelect™ AAV Affinity Resin

The use of POROS™ CaptureSelect™ AAV Affinity Resins represents a significant improvement in downstream processing of AAV vectors.

The unique CaptureSelect™ ligand technology is combined with the large pore structure of POROS™ resins to enable the development of large biomolecules such as viral vectors and vaccines.

  • Limit the number of steps in the AAV purification process and maximize productivity
  • Increase purity and yield in a single capture step
  • Increase process flexibility and throughput
  • Upgrade the AAV production process
  • Build a single purification platform for multiple AAV serotypes















Non-pathogenic adeno-associated virus (AAV) has emerged as a vector of choice for many gene therapies. However, purification of biologically active viral vectors for large-scale commercial use requires long development lead times, yield losses per unit operation, and challenging raw materials.

Thermo Fisher Scientific has developed downstream purification solutions that enable scaling up viral vector production. POROS™ and CaptureSelect™ AAV affinity resins provide a scalable capture step for a wide range of AAV serotypes and offer a significant improvement in the downstream processing of these molecules.

Advantages

- Fewer chromatography steps = higher yield
- Simplified, scalable and consistent process
- Lower overall cost and complexity














SDS-PAGE comparing the purity of the AAV9 viral vector purified by two downstream processing methods; one uses 3 IEX steps and the other 1 affinity capture step with POROS CaptureSelect AAV9 resin.

The data show that the purity profile of the viral vector AAV9 is equivalent when comparing both downstream processing approaches.

The gel also reveals similar purity, and the capsid viral protein (VP) topology for the viral vector AAV9 is confirmed by showing bands corresponding to the viral structural proteins VP1, VP2 and VP3.














Vector recovery throughout the processing step was approximately 70%.
Vector recovery remained consistent at 20x scale, indicating the scalability of the resins.

POROS™ CaptureSelect™ AAVX Affinity Resin is engineered to address the high selectivity and capacity requirements for large-scale downstream purification of a broad range of naturally occurring and synthetic adeno-associated virus (AAV) serotypes used for gene therapy applications. POROS™ CaptureSelect™ AAVX resin has demonstrated binding reactivity towards a set of AAV serotypes that includes AAV1 to AAV8, and AAVrh10 as well as synthetic serotypes.

Features of POROS™ CaptureSelect™ AAVX resin include:
• One-step AAV purification from crude material with high purity and yield
• High specificity and capacity, maximizing yield by significantly reducing process steps
• Superior capacity maintained at high flow rates
• Excellent scalability and easier handling and packing due to rigid polymeric bead
• Non-animal derived

POROS™ CaptureSelect™ AAVX Affinity Resin enables a robust, fast, and platformable purification process for wide-ranging AAV serotypes with excellent purity and yield obtained in one step. This resin comes with complete technical and regulatory support.


Main Characteristics

Matrix: cross-linked poly(styrene-divinylbenzene) POROS beads
Average particle size: 50 µm
Ligand: CaptureSelect AAVX affinity ligand
Binding capacity: >1x1013 genome copies/mL of resin
Elution conditions: acidic elution with 0.1 M glycine, pH 3.0
Mechanical resistance: 100 bar (1,450 psi; 10 MPa)
Formulation buffer: 18% (v/v) ethanol






















 


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