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    Biopharmaceutical Purification

    Each of the steps in the downstream purification process is designed to increase the purity of the biologic product such as biosimilars, vaccines and cell and gene therapies. Efficient downstream purification processes under optimal conditions allow high purity and high production yields. Purification separates contaminants that are similar to the physical and chemical properties of the biologic product itself, such as DNA fragments, proteins, ions or cell debris, from the feedstock.

    Pure and Simple Process

    Chromatography is a fundamental operation used in downstream purification of biopharmaceutical products. It separates the components of a feed mixture by slow passage over or through a material that absorbs the components differently. Various techniques use the differences in molecular properties of the components to separate the desired product and impurities.

    Chromatography: A State of Purity and Precision

    The feed mixture from the upstream process is dissolved in the mobile phase fluid. Once the mobile phase is ready, it flows through or over the surfaces (e.g., columns, beds) for the stationary phase. During chromatography, the stationary phase is the medium affected by the separation process. A Liquid Handling Module (LHM) systematically delivers the mobile phase to and from the stationary column to isolate and purify the product.

    Types of Adsorptive Chromatography used in Biopharma

    • Affinity
    • Column
    • Gelfiltration (molecular sieve)
    • Hydrophobic interaction
    • Ion exchange
    • Mixed modThin laye

    purification-image

    CPC Expertise & Experience Assist in Biopharmaceutical Purification Process Designs

    Biopharmaceutical manufacturers are increasingly focused on downstream purification processes and workflows to manage the high-productivity outputs from upstream processes, the use of continuous bioprocessing and the growth in cell and gene therapies. CPC’s team of biopharma design and application engineers understand the need to streamline purification and chromatography workflows through efficient media handling that results in high purity and high yield biologic production. 

    Enhance Purification Separation Processes with CPC Aseptic Connectors

    The broad portfolio of innovative CPC aseptic and steam-in-place connectors provides the appropriate connection technologies to help enhance downstream purification and chromatography processes for maximum productivity, efficiency and safety. Versatile, single-use CPC aseptic connectors ensure closed connection and disconnection for transferring mobile phase fluids while managing the impurities separated during the various chromatographic separation processes. By helping optimize purification workflows, CPC aseptic and steam-in-place connectors provide a competitive advantage with increased efficiency and improved throughput while helping make quick changeovers due to changing feed mixture properties.

    Versatility and Flexibility

    CPC’s aseptic and SIP connectors provide flexibility for biopharmaceutical manufacturers to easily combine multiple components including process containers, tubing manifolds, single-use and metal transfer lines, bioreactors and other bioprocess equipment. When changeovers need to occur, genderless CPC aseptic connectors and SIP connections make it easy to connect and disconnect purification and chromatography components and processes. Multiple termination options meet today’s mounting and flow requirements.

    Innovative Design

    Downstream purification and chromatography processes and techniques differ widely, CPC’s comprehensive portfolio of aseptic and SIP connectors meet the need for a wide variety of sizes, configurations, termination options and materials. Our team of biopharma design and application engineers develop innovative, high-quality products that make sterile media transfer safe and easy. Innovative connection methods help eliminate contamination risk and provide connection assurance.

    Trusted Reliability

    CPC aseptic and SIP connectors are engineered for upstream and downstream applications including purification and chromatography. To help maintain aseptic transfer of feed mixtures, CPC connection solutions are rigorously tested―including materials testing, product testing and torture tested to failure―to meet product specifications. As a matter of fact, CPC offers reliable, reproducible performance and provides validation and extractable reports that support the performance attributes.

    Overall Robustness

    CPC aseptic connectors and Steam-Thru® Connections deliver optimized flowrates with excellent flow to size ratio for superior performance to manage the media transfer required during biopharmaceutical purification separation processes. CPC purpose-built connectors are designed to be compatible with a wide variety of chemicals to meet the needs of purification and chromatography systems. We provide a unique combination of industry expertise with the broadest portfolio of products including sterile connects, sterile disconnects, SIP connections and quick connects.

    Sterility Assurance

    Increased cell densities and product diversity is driving manufacturers to design their biopharmaceutical purification systems to manage shorter production runs with multiple changeovers. Robust and easy-to-use, single-use, aseptic connectors and SIP connections from CPC maintain flow path sterility and integrity while enabling biopharmaceutical manufacturers to use the necessary purification processes and systems that meet their cell yields and cost targets.

    Assurance of Supply

    CPC has a proven track record of providing products consistently under their stated specifications and quality requirements through having a strong supply assurance program. The program includes control of the manufacturing process from raw materials to final product manufacturing. Investments in extra capacity and redundant manufacturing ensure capacity when it's needed. Biopharma customers have confidence in CPC’s ability to fulfill demand acquired by a track record of accurate lead times, identifying and communicating potential delays and, most importantly, by sound supply chain management.

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    Sterile Connectors

    Easy-to-use AseptiQuik® and MicroCNX® Connectors provide quick and sterile connections, even in non-sterile environments—a critical capability for your biopharmaceutical manufacturing.

    Sterile Disconnectors

    With an easy push of the connector thumb latch, our sterile disconnectors maintain sterility on both sides of the system during disconnection.

    Sterile Combination Connectors

    Be assured of both a sterile connect and sterile disconnect with our all-in-one, single-use AseptiQuik® DC connection technology.

    Open Format Connectors

    Transfer media quickly and easily between single-use bag systems, tube sets and stainless process equipment.

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