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Efficient TFF System for Monoclonal Antibodies - China Suppliers & Factory for Flexible Filtration Solutions

Introducing our advanced single-use tangential flow filtration (TFF) system, tailored for manufacturers in China. This fully automated solution is designed with GMP-compliant fluid contact materials, ensuring the highest standards of quality for your filtration processes. As reliable suppliers, we provide efficient and flexible filtration solutions suitable for various production needs, spanning from clinical development to commercial manufacturing, Our intuitive operation allows for seamless scalability across different process scales, enabling users to significantly reduce both production time and costs. This cutting-edge TFF system is extensively utilized by factories involved in the manufacturing of monoclonal antibodies, ADCs, gene therapies, viral products, mRNA vaccines, and plasmid DNA. It effectively supports crucial processes including concentration, purification, and continuous buffer exchange, making it an essential tool for modern biopharmaceutical production in China
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    Product Detail

    Features

    Single-use design concept easily addresses the challenges of cleaning validation.

    High level of automation from automatic feed to online integrity testing, the entire TFF process is fully automated, minimizing risks from manual intervention and achieving truly intelligent tangential flow operation.

    Supports PUPSIT (Pre-Use Post-Sterilization Integrity Testing), compliant with MEA and other relevant regulatory requirements.

    Compact tubing layout ensures minimal hold-up volume.

    Flexible membrane compatibility, supports both cassette membranes and hollow fibers.

    Adaptable to different setups, flexibly integrate with various single-use bags or tanks based on user requirements.

    Compliant with FDA 21 CFR Part 11, complete validation documentation is provided.

    Frequently Asked Questions

    Q:How does this system simplify cleaning validation?

    The system features a single-use design concept, which easily and effectively addresses the traditional challenges associated with cleaning validation.

    Q:What automated processes are included in the TFF system?

    The entire TFF process is fully automated, covering everything from the automatic feed to online integrity testing. This high level of automation minimizes manual intervention risks and achieves intelligent tangential flow operation.

    Q:Does the system comply with PUPSIT requirements?

    Yes, the system supports PUPSIT (Pre-Use Post-Sterilization Integrity Testing) and is fully compliant with MEA and other relevant regulatory standards.

    Q:What design features help minimize hold-up volume?

    The system is engineered with a highly compact tubing layout that specifically ensures minimal hold-up volume during operation.

    Q:What types of membranes and vessels can be used with this system?

    It offers flexible membrane compatibility, supporting both cassette membranes and hollow fibers. Additionally, it is adaptable to different setups and can flexibly integrate with various single-use bags or tanks based on your specific requirements.

    Q:Is the system compliant with FDA 21 CFR Part 11?

    Yes, the system is fully compliant with FDA 21 CFR Part 11, and complete validation documentation is provided to support your regulatory compliance.