BioPro IEX Bulk Media

BioPro IEX Bulk Media

IEX Stationary Phases for Preparative Chromatography

BioPro IEX Bulk Media

    Particle Technology

    Ion exchange media is widely used in the analysis and purification of biomolecules. For instance, in industrial-scale protein production processes, IEX media are often used for initial product capture and intermediate purification stages as well as the final polishing steps. Using reversible charge-charge interactions offers several advantages over in comparison to other chromatographic methods, e.g. high capacity and fast throughput.


    BioPro and BioPro SmartSep form a series of ion exchange resins specifically designed for biochromatography. It is available as a strong anion exchanger (BioPro Q) and a strong cation exchanger (BioPro S).


    The media is based on a hydrophilic polymer matrix, with a particle size of 10 µm, 20 µm, 30 µm and 75 µm.


    BioPro offers a high dynamic binding capacity (DBC), together with low non-specific adsorption and excellent recovery. BioPro is manufactured in lot sizes up to 450 L.

     

    Guide to IEX Media Selection

     

    Guide to IEX Media Selection

    Specifications
     
    BioPro
    SmartSep
    Q10/Q20/Q30
    BioPro
    Q75
    BioPro
    SmartSep
    S10/S20/S30
    BioPro
    S75
    Ion exchange type Strong anion exchanger Strong cation exchanger
    Charged group -R-N+(CH3)3 -R-SO3-
    Matrix Hydrophilic porous polymer beads
    Particle Size [µm] 10, 20, 30 75 10, 20, 30 75
    pH range 2 - 12
    Ion exchange capacity
    [meq/mL resin]
    min. 0.08
    min. 0.10
    min. 0.08
    min. 0.10
    Dynamic binding capacity
    [mg/mL resin]
    min. 110 (BSA)
    min. 160 (BSA)
    min. 110 (lysozyme)
    min. 160 (lysozyme)
    Compression factor
    1.05-1.15
    Typical flow rate
    200-1000 cm/h, Max. 2000 cm/h

     

     
     

    Bio Pro S75 Particle

    BioPro S75 Particle

     

    Advantages of BioPro Resins
    BioPro 75 µm features   Intermediate purification and polishing

    Excellent dynamic binding capacity (DBC)

     

    Solution for challenging separations

    Low non-specific adsorption and high recovery

     

    Increase productivity

    High capacity with low operating  pressure even

    at high flow rates

     

    Reduced processing costs

    Full compliances with GMP requirements

     

    Short delivery time for industrial-scale quantities

    Short delivery for industrial-scale quantities

     

    Full compliance with GMP regulations

    Reduced  processing costs

     

     

     

    Availability and Regulatory Support

    YMC Mission Statement

    YMC provides separation technology for the entire lifecycle of pharmaceutical compounds.

    YMC will never knowingly change any product that is being used in a validated production process or validated analytical method.

    Worldwide availability, FDA/GMP

    Regulatory support file avaible under non-disclosure agreement. Use in validated cGMP-manufacturing processes. Customised material avaible on request. DMF registerd with FDA.

     

     

    Examples of Possible Preparative Applications of BioPro Resins
    Antibody Purification Protein Purification Peptide Purification
    Trastuzumab Histones Insulin
    Bevacizumab Interferon  
    IgG, antibody variants Factor VIII, Factor IX  
    Purification of monoclonal antibodies

    Ion exchange (IEX) is widely used for the analysis and purification of bio-molecules such as protaeins, peptides and monoclonal antibodies.

    In industrial-scale production, IEX is used for initial capture, intermediate purifications or final product pollishing.

     

    Challenges during mAb purification

    For purification of monoclonal antibodies, high demandes are required from the separating material. Factors influencing the binding characteristics of lgG are pH, linear elocity and/or salt concentration (at the time the sample is loaded onto the column.

     

     

    Purification of Monoclonal Antibodies

     

    Examples of Preparative Applications

    • Antibody Purification
    • Protein Purification
    • Peptide Purification
    • Oligonucleotide Purification

     

    Separation of Proteins in Human Serum on BioPro QA and commercial Q Type Products
    Separation of a Standard Text Mixture of Proteins
    Purification of Proteins

     

     

    Two step purification of IgY

    High Dynamic Binding Capacity: The dynamic binding capacity of BioPro is excellent even at high flow rates. This results in higher sample loading in your preparative process.

    Cleaning in Place: BioPro is well suited for alkaline CIP procedures.

    Stability towards alkaline conditions: The high chemical stability of BioPro resins allows effective cleaning and economic purifications.

    Scalability across All Particle Sizes: The consistent performance across all particle sizes is advantageous for seamless method transfer between particle sizes.

     

    Excellent Dynamic Binding Capacity at High Linear Flow Rates
    Cleaning in Place (CIP)

    BioPro S75 is well suited for alkaline CIP procedures. The dynamic binding capacity (DBC) and the selectivity are unaffected by 20 cycles of CIP with 1.0 M NaOH. The recovery of proteins is maintained at 100%, which demonstrates the absence of nonspecific adsorption of proteins of this hydrophilic resin.

    Stability towards alkaline conditions

    Stability towards alkaline conditions is essential for efficient sanitizing procedures in a highly regulated environment.
    BioPro Q75 demonstrates excellent tolerance towards challenging alkaline conditions. Stability testing shows that 0.1 M NaOH is suitable for long term storage of BioPro. The high chemical stability of BioPro resins allows effective cleaning with alkaline solution and the longevity this material ensures efficient and economic purifications.

    Loading Study for BioPro QA – Proteins
    Low Backpressure
    Title Document Type Language Phase Type Download
    Purification of Insulin and Lysozyme with BioPro IEX SmartSep Application Note E
    Purification of monoclonal antibodies with BioPro IEX SmartSep Application Note E
    BioPro IEX materials Brochure E
    BioPro IEX Packing, Care and Use Care and Use Instructions E
    BioPro IEX Prep 75 um Care and Use Care and Use Instructions E
    BioPro IEX Screening Kit Care and Use Care and Use Instructions E
    BioPro IEX SmartSep Prep 10, 20, 30 um Care and Use Care and Use Instructions E
    MSDS BioPro IEX Prep Bulk MSDS E
    Bulk Packing Material for Preparative Chromatography Overview E
    Purification of biopharmaceutical proteins and peptides using ion-exchange bulk media designed for high-throughput purification Poster E Please login
    BioPro IEX SmartSep Q und S in 10, 20 und 30 µm Product Information E Please login

    Request Now

    Please contact YMC for pricing or specific solutions for your purification process.

    Michael Ostendorf

    Product Manager Bulk Media

    ph. +49 (0)2064 427-280

    Product Particle Size Product Code
    BioPro SmartSep Q10 10 µm QSA0S10
    BioPro SmartSep Q20 20 µm QSA0S20
    BioPro SmartSep Q30 30 µm QSA0S30
    BioPro Q75 75 µm QAA0S75
    BioPro SmartSep S10 10 µm SSA0S10
    BioPro SmartSep S20 20 µm SSA0S20
    BioPro SmartSep S30 30 µm SSA0S30
    BioPro S75 75 µm SPA0S75

     

    Typical pack sizes:

    50 mL, 250 mL, 1 L, 5L, 10 L, 20 L
    Larger or customised pack sizes are available on request.

     

    Regulatory support file under non-disclosure agreement. Used in validated cGMP-manufacturing processes. Customised material available on request. DMF registered with FDA.

     

     

    Please login to see the prices (if needed insert link to login page).

    Product Description Price (EUR) Stock
    BPQAA0S75-01PK BioPro IEX Q75, 100 nm, S-75 µm, 1 mL column (5 per unit) -
    BPQAA0S75-05PK BioPro IEX Q75, 100 nm, S-75 µm, 5 mL column (5 per unit) -
    BPQSA0S30-01PK BioPro IEX SmartSep Q30, 100 nm, S-30 µm, 1 mL column (5 per unit) -
    BPQSA0S30-05PK BioPro IEX SmartSep Q30, 100 nm, S-30 µm, 5 mL column (5 per unit) -
    BPSPA0S75-01PK BioPro IEX S75, 100 nm, S-75 µm, 1 mL column (5 per unit) -
    BPSPA0S75-05PK BioPro IEX S75, 100 nm, S-75 µm, 5 mL column (5 per unit) -
    BPSSA0S30-01PK BioPro IEX SmartSep S30, 100 nm, S-30 µm, 1 mL column (5 per unit) -
    BPSSA0S30-05PK BioPro IEX SmartSep S30, 100 nm, S-30 µm, 5 mL column (5 per unit) -
    • 2-3 days
    • 1-2 weeks
    • 3-4 weeks

    Related Categories

    Contact

    • Michael Ostendorf
    • Product Manager
    • Bulk Media
    • ph. +49 (0)2064 427-280