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Purification Techniques: MaXtar® Q HR: High-Resolution is not a Claim

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    With the continuous development of pharmaceutical industry and increasingly various biological products, the market demands to high resolution chromatography resin is increasing. By virtue of its excellent separation and stable property, MaXtar® Q HR resin has been applied in clinical stage of antibody, vaccine and recombinant protein and marketed projects. This article will introduce its features and performances fully.


    1.Batch-to-batch Consistency Performance


    purification-techniques-maxtar-q-hr-high-resolution-is-not-a-claim1.jpg


    Figure 1. MaXtar® Q HR binding capacity performance between three batches


    Summary: Using BSA standard protein to characterize the binding capacity of MaXtar® Q HR, there is no obvious differences between batches.


    2.Superior Virus-removal Ability


    ProjectPhaseLRV
    Project 1IND>4
    Project 2Phase II>5


    Table 1. Virus-removal validation performance in different projects


    3.Industrial Scale-up Performance

    01.Pressure flow rate curve


    purification-techniques-maxtar-q-hr-high-resolution-is-not-a-claim2.jpg


    Figure 2. MaXtar® Q HR pressure flow rate curve



    02.Production-scale Column Packing


    Column SpecificationD=1200 H=21.5 cm
    Column Efficiency HETP9471
    Symmetry AS1.01


    purification-techniques-maxtar-q-hr-high-resolution-is-not-a-claim3.jpg



    Summary: MaXtar® Q HR is based on the MaXtar® high-flow improved agarose matrix. When the pressure reaches up to 3 bar, the linear flow rate is ≥ 300 cm/h, and it has been successfully applied in industrial production.


    Case Share

    Application 1

    Sample Information: lgG


    purification-techniques-maxtar-q-hr-high-resolution-is-not-a-claim4.jpg


    Figure 3. HCP removal and recovery rate performance of different anion


    Summery: MaXtar® Q HR possesses both high recovery rate and excellent HCP removal capability in antibody projects. The HCP removal effect and recovery performance after IgG purification are better than those of other domestic manufacturers.


    Application 2

    • Sample Information: Plasmid DNA

    • Volume of Column: H=15 cm, D=26 mm

    • Equilibrium Buffer: 100 mM Tris-HCl, 0.4 M NaCl 10 mM EDTA, pH 7.5

    • Elution Buffer: 100 mM Tris-HCl,1.0 M NaCl 10 mM EDTA, pH 7.5 (0-100%B,5 CV)


    purification-techniques-maxtar-q-hr-high-resolution-is-not-a-claim5.jpg


    Figure 4. Plasmid DNA purification chromatogram


    Summery: MaXtar® Q HR possesses excellent separation ability in plasmid projects. After linear elution, RNA residuals can be removed efficiently.


    Recommendations for process optimization

    MaXtar® Q HR is widely used in recombinant protein and antibody projects. It mostly adopts the flow-through mode, and the main purpose is to remove exogenous impurities. In the early stage of process development, the optimization of loading pH and conductivity, as well as the loading amount, are the key parameters of the flow-through mode. With the help of DoE experiments, the optimal experimental conditions can be quickly found. In applications such as vaccines, MaXtar® Q HR mostly adopts the binding mode. In the early stage of process development, elution with salt concentration is given priority. If the sample cannot be effectively separated or the resolution is low, the salt concentration for elution can be appropriately extended. After the separation effect is achieved, the stepwise elution method can be optimized. If the loading capacity is low, the pH can be appropriately increased to enhance the ion interaction and improve the loading capacity.


    Products Catalog Number

    Products Name Cat. No. Pack Size
    MaXtar® Q HR1014-181125 mL
    1014-1812100 mL
    1014-1813500 mL
    1014-18141L
    1014-18155 L
    1014-181610 L
    1014-181720 L
    Chrom-Trap® MaXtar® Q HR 1mL 2014-18111×1 mL
    Chrom-Trap® MaXtar® Q HR 4.7mL2014-18121×4.7 mL
    Chrom-Trap® MaXtar® Q HR 5mL 2014-18131×5 mL


    References

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