BioPro IEX Bulk Resins

IEX Resins for Downstream Processing

    Ion Exchange Resins

    Ion exchange media are widely used in the 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. This separation technique offers several advantages in comparison to other chromatographic methods, e.g. high capacity and fast throughput.

    BioPro IEX and BioPro IEX SmartSep form a series of ion exchange resins specifically designed for biochromatography. They are available as a strong anion exchanger (BioPro IEX Q) and a strong cation exchanger (BioPro IEX S).
    The media are based on a hydrophilic polymer matrix, with a particle size of 10 µm, 20 µm, 30 µm and 75 µm. BioPro IEX offers a high dynamic binding capacity (DBC), together with low non-specific adsorption and excellent recovery. BioPro IEX is manufactured in lot sizes up to 450 L.

     

    Advantages

    • Excellent dynamic binding capacity
    • Low non-specific adsorption and high recovery
    • High capacity even at high flow rates
    • Full compliances with GMP requirements
    • Increased productivity
    • Reduced processing costs
       

    Available Ion Exchange Resins:

    AEX Resins

    CEX Resins

    AEX and CEX Resins

    AEX Resins
     BioPro IEX SmartSep Q10BioPro IEX SmartSep Q20BioPro IEX SmartSep Q30BioPro IEX Q75
    Ion Exchange Typestrong anion exchanger
    Charged Group-R-N+(CH3)3
    Base Materialhydrophilic polymer beads
    Particle Size [µm]10203075
    pH Range2.0 - 12.0 (compatible with 1 M NaOH for CIP)
    Ion Exchange Capacity
    [meq/mL resin]
    min. 0.08
    min. 0.08
    min. 0.08
    min. 0.10
    Dynamic Binding Capacity
    [mg/mL resin]
    min. 110 (BSA)
    min. 110 (BSA)
    min. 110 (BSA)
    min. 160 (BSA)
    Compression Factor
    1.05-1.15
    Typical Flow Rate
    		200-1000 cm/h, max. 2000 cm/h
    Pressure Limit
    		4 MPa3 MPa3 MPa0.3 MPa

     

    CEX Resins
     BioPro IEX SmartSep S10BioPro IEX SmartSep S20BioPro IEX SmartSep S30BioPro IEX S75
    Ion Exchange Typestrong cation exchanger
    Charged Group-R-SO3-
    Base Materialhydrophilic polymer beads
    Particle Size [µm]10203075
    pH Range2.0 - 12.0 (compatible with 1 M NaOH for CIP)
    Ion Exchange Capacity
    [meq/mL resin]
    min. 0.08
    min. 0.08
    min. 0.08
    min. 0.10
    Dynamic Binding Capacity
    [mg/mL resin]
    min. 110 (Lysozyme)
    min. 110 (Lysozyme)
    min. 110 (Lysozyme)
    min. 160 (Lysozyme)
    Compression Factor
    1.05-1.15
    Typical Flow Rate
    		200-1000 cm/h, max. 2000 cm/h
    Pressure Limit
    		4 MPa3 MPa3 MPa0.3 MPa

     

    Multiple Sample Options Available!

     

     

    The image shows the various sample options for BioPro IEX
    Multiple sample options for BioPro IEX – bulk resin samples or prepacked column formats available

    Resin Properties

    Excellent Dynamic Binding Capacity at High Linear Flow Rates

    High sample loading at high flow rates is determined by the dynamic binding capacity of an ion exchange resin. The dynamic binding capacity of BioPro is excellent even at high flow rates. When compared to similar competitor products it consistently exhibits a higher dynamic binding capacity. This results in higher sample loading in preparative processes.

    Full Scalability

    One of the advantages of YMC’s BioPro IEX resins is its full scalability. This property provides an identical chromatographic behaviour across all particle sizes. This is beneficial, as separation and fractionation can be optimised on the analytical scale. Depending on the required resolution the optimal bead size can be selected. Then, the process can be reliably transferred to the production scale. This enables highly flexible implementation of BioPro IEX resins, resulting in a perfectly tailored solution.

    The image shows the identical retention profiles of the ion exchange resins by YMC with different particle sizes (10 µm, 20 µm, 30 µm and 75 µm). This enables increased flexibility in downstream process development.
    The BioPro IEX resins by YMC are available at various particle sizes with completely comparable retention profiles. This enables highly flexible process implementation of the BioPro IEX resins, resulting in a perfectly tailored solution.
    Compatibility to Alkaline CIP Procedures

    Cleaning-in-place (CIP) is essential for the economic use of packed chromatography columns. Efficient cleaning procedures increase the lifetime of the separation process and thereby contribute to the overall cost effectiveness. Furthermore, powerful CIP procedures strongly increase the safety and productivity of every downstream process.

    IEX resins from YMC are fully compatible to typical CIP procedures. As an example, CIP studies have been performed using NaOH solutions with BioPro IEX S75/IEX Q75 as well as with BioPro IEX SmartSep S30/Q30. All YMC IEX resins maintain their performance values even after 100 CIP cycles.

    The image shows the results from a Cleaning-in-Place study with the ion exchange resins by YMC. The resins remain their excellent capacity even after 100 CIP-cycles with 1 M NaOH.
    A CIP-study shows: BioPro IEX resins from YMC are fully compatible to typical CIP procedures. All YMC IEX resins maintain their high performance values even after 100 CIP cycles.
    Low Backpressure

    The pressure flow characteristics of IEX resins are mainly based on the physical properties of the base beads used for the resin. In general, the particle size of the resin is the overriding parameter responsible for the separation efficiency according to the diffusion processes and for the inherent backpressures during the chromatographic processes.

    Here, the pressure flow characteristics of BioPro IEX Q75 from YMC and Q Sepharose FF from Cytiva are compared. The YMC resin shows much better pressure flow characteristics. This may be related to the rigidity of the base beads used. As a result, the YMC resin can be used over a greater flow rate range and with higher flow rates. For a pressure range of up to 3 bar, the YMC resin can be used with flow rates of up to 800 cm/hr for a bed length of 24 cm.

    The image shows the pressure flow curves of BioPro IEX Q75 and Q Sepharose FF. BioPro IEX shows lower backpressure and allows higher flow rates.
    Pressure flow curves for YMC’s BioPro IEX Q75 and Q Sepharose FF from Cytiva. BioPro IEX shows excellent pressure flow characteristics and allows higher flow rates.

    Examples of

    Preparative Purifications

    Antibodies

    For the purification of monoclonal antibodies high demands are required from the resin used. Factors influencing the binding characteristics of IgG are pH, linear velocity and/or salt concentration (conductivity) at the time the sample is loaded onto the column. Therefore, a resin with highly stable performance is required with regard to all those factors. In order to demonstrate the performance of BioPro IEX resins, several studies have been performed.

    Oligonucleotides

    Nucleic acids such as antisense RNA (asRNA), small interfering RNA (siRNA) and aptamers are expected to be the next generation of biopharmaceuticals. In order to provide these drugs, purification and analytical separations that can recognize slight structural differences after synthesis are important issues.

    The image shows the separation of different single-strand 20mer and 21mer oligonucleotides using BioPro IEX QF with very high resolution.
    High resolution separation of single-strand oligonucleotides with single-nucleotide differences using a BioPro IEX column
    Plasma Proteins

    The increasing complexity of the plasma proteins requires new solutions to increase the purity and productivity of the downstream processes. YMC’s BioPro IEX resins are available with a comparable selectivity in analytical particle sizes of 3 µm and 5 µm as well as in preparative particle sizes of 10 µm, 20 µm, 30 µm and 75 µm. The smaller the particle size, the better the resolution. The example shows the separation of a plasma protein sample using a 5 µm resin with a 50 mm bed length. This separation can be easily transferred to preparative grade particle sizes allowing a high purity isolation of the related compounds to be achieved.

    The image shows the high resolution separation of human plasma proteins with anion exchange chromatography at 5 µm particle size.
    High resolution separation of proteins in human serum using the 5 µm AEX resin BioPro IEX QF
    Proteins and Peptides

    BioPro IEX SmartSep S30 maintains its high resolution and high sample loading ability even at 1600 cm/hr and under high loading condition (30 mg/mL). It allows up to 50 % higher recovery for specific target compounds compared to the competitor’s materials. These features of the BioPro IEX SmartSep material indicate the possibility of cost savings for your purification.

    The image shows a comparison of different ion exchange resins for protein purification (Lysozyme, Ribonuclease A, Cytochrome c). BioPro IEX revealed the best resolution and highest recovery.
    Comparison of the purification of different proteins with BioPro IEX and alternative materials. BioPro IEX shows the best resolution and highest recovery for all proteins.
    Two Step Purification of IgY

    IgY is a commonly used immunoglobulin from egg yolk. In contrast to human IgG-antibodies, IgY does not bind to Protein A which makes the preparative purification of these molecules challenging. This application shows the successful two-step purification of IgY using IEX as an efficient capturing step.

    Technical Library

    Title Document Type Language Download
    Application NotePurification of Insulin and Lysozyme with BioPro IEX SmartSep Application Note EN
    Download
    Application NotePurification of monoclonal antibodies with BioPro IEX SmartSep Application Note EN
    Download
    BrochureBioPro IEX Materials by YMC Brochure EN
    Download
    BrochureBioPro IEX Materials by YMC (HQ) Brochure EN
    Download
    Care and Use InstructionsBioPro IEX 75 µm Care and Use Care and Use Instructions EN
    Download
    Care and Use InstructionsBioPro IEX Screening Kit Care and Use Care and Use Instructions EN
    Download
    Care and Use InstructionsBioPro IEX SmartSep 10, 20, 30 µm Care and Use Care and Use Instructions EN
    Download
    OverviewPacken der BioPro IEX Resin in Glassäulen Overview DE
    Download
    OverviewPacking of BioPro IEX Resins into Glass Columns Overview EN
    Download
    OverviewYMC Resins for Preparative Bioseparations Overview EN
    Download
    PosterPurification of biopharmaceutical proteins and peptides using ion-exchange bulk media designed for high-throughput purification Poster EN
    Download
    Product InformationImproving the downstream processes of plasma proteins Product Information EN
    Download
    Product InformationOptimierungspotentiale von Prozessen für Plasmaproteine Product Information DE
    Download
    Technical NoteExcellent alkaline CIP stability of YMC IEX Technical Note EN
    Download
    Technical NotePressure flow characteristics of BioPro IEX Q75 by YMC Technical Note EN
    Download
    WhitepaperGrundlagen der Chromatographie für die Analyse und Aufreinigung von Biologika Whitepaper DE
    Download

    Request Now

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

    Julia Bartmann

    Product Manager Bulk Media

    ph. +49 2064 427-260

     

    ProductParticle SizeProduct Code
    BioPro IEX SmartSep Q1010 µmQSA0S10
    BioPro IEX SmartSep Q2020 µmQSA0S20
    BioPro IEX SmartSep Q3030 µmQSA0S30
    BioPro IEX Q7575 µmQAA0S75
    BioPro IEX SmartSep S1010 µmSSA0S10
    BioPro IEX SmartSep S2020 µmSSA0S20
    BioPro IEX SmartSep S3030 µmSSA0S30
    BioPro IEX S7575 µmSPA0S75

     

     

    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.

     

     

    Multiple Sample Options Available!

     

     

    The image shows the various sample options for BioPro IEX
    Multiple sample options for BioPro IEX – bulk resin samples or prepacked column formats available

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