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VNenServicesCustom Product DevelopmentEshmuno® Fit Custom Affinity Resin Development Services

Eshmuno® Fit Custom Affinity Resin Development Services

Streamline your downstream processing with Eshmuno® Fit custom affinity resin development services. Our approach utilizes tailored caustic-stable Nanofitin® ligands designed specifically for your target molecule and conjugates them to our well-established Eshmuno® base beads. This enables the creation of custom and optimized affinity resins to address your specific purification challenges.

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Benefits:

  • High yield, even for difficult-to-purify molecules
  • High purity levels can be achieved in just one step, streamlining the purification process
  • Improves and simplifies the overall purification workflow by reducing the number of downstream processing steps
  • Cost savings from optimized and simplified downstream processes, high efficiency, and increased recovery of valuable therapeutics
  • Easy to scale, ensuring consistent performance through scale-up and flexible manufacturing

Why choose Eshmuno® Fit custom affinity resin development services?

  • Diversity: Our technology relies on a library of over 1e14 Nanofitin® variants, enabling custom generation of ligands for affinity separation of various target molecules such as vaccines, viral vectors, and novel mAbs.
  • Tailored caustic stability: Allows for reusability and the reduction of consumables costs.
  • Versatility: Randomization of binding sites combined with a ribosomal display screening platform allows for the customization of ligands to specific interactions and tailored process conditions.
  • Templated manufacturing: Manufactured under controlled conditions. Established quality system, certified ISO 9001, and Rx-360 audited site.
  • Project execution: Ensuring the implementation of the custom affinity resin from start to finish through our dedicated team of technical experts and project managers.

Eshmuno® FIT Framework

Scientist in a lab working with samples and an electronic pipette

Ligand Discovery & Characterization

  • Comprehensive Nanofitin® ligand screening tailored to your specific purification needs
  • Identification of up to 20 ligands
  • Affinity constant determination (KD), elution condition screening, and testing of relevant process parameters
    Scientist in a lab carefully looking at a test tube that she is holding in her hands
    • Up to 3 pre-packed prototypes of selected ligands coupled with Eshmuno® matrix
    • Physical characterization testing
    • Functional testing, including static binding capacity, dynamic binding capacity, and cleaning-in-place
      Scientist in a lab, in front of a monitor, using some test tubes to run experiments
      • 6 statistical batches, including bicinchoninic acid (BCA) protein assay and dynamic binding capacity
      • Research scale production (ISO9001)
      • QC testing, including bicinchoninic acid (BCA) protein assay, dynamic binding capacity, etc.
        Scientist in production plant, fully gowned
        • Scale-up of Nanofitin® ligand and resin production
        • Definition of extended specifications
        • Validation of analytical methods
        • Process validation through qualification batches
        • Quality and regulatory compliance for GMP applications
        • Regulatory support files

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