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    Single-Use Technology for Gene Therapy

    THE connection solution for Cell and Gene Therapy - MicroCNX®

    Gene Therapy Uses: Hope for the Prevention of Diseases

    With new and ever-evolving genetic engineering technologies, researchers are finding new ways to treat diseases that currently have only symptomatic treatment or no treatment standard. The use of gene therapies offers promise for treating and curing a wide range of diseases, including  cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS. 

    The ultimate goal — and hope — is for gene therapy to be used to treat all genetic diseases. While still an experimental technique, recent gene therapy approvals from the FDA and EMA along with more than 1,000 different types of gene therapies in clinical trials, have seen rapid, exciting growth.

    Lean on CPC’s Cell and Gene Therapy (CGT) Expertise

    By collaborating with manufacturers and partnering with equipment suppliers, CPC helps provide revolutionary gene therapies in a faster time frame. Our sterile, single-use connectors for gene therapy are a technology that helps in making sure efficacious, repeatable and standardized processes are maintained.

    CGT manufacturers face many struggles — the high costs of production, labor, supply chain and yield management. CPC helps make this process easier and more affordable by offering solutions for closed-system design alongside our quick connects for gene therapy.

    View presentation on the Future of Cell and Gene Therapies

    Closed System Use for Gene Therapy’s Smaller Batches 

    While any drug development program can face uncertainties, developing cellular and gene therapies (CGT) presents unique challenges above and beyond those encountered for bioprocessing’s small molecule drugs. A closed system designed for gene therapy manufacturing provides the protection of a cleanroom against outside contaminants without the costs associated with maintaining it. Closed systems are becoming widely used in SUT (single-use technology) facilities for monoclonal antibodies, recombinant protein and vaccine production while the adoption of closed systems at lab scale for smaller batches for CGT manufacturing is gaining ground.

    Simplify Gene Therapy Processes with CPC Sterile Connectors 

     Easy-to-use CPC aseptic connectors help reduce system complexity and production costs by offering enhanced flexibility and reliability. The simple integration of SUT plug-and-play assemblies with quick connects for gene therapy eliminates the complicated process for connecting tubes via tube welding. Using CPC aseptic connectors means there is no need to bring a tube welding cart and components into the production suite, then moved to the biosafety cabinet to be put together. Gene therapy manufacturers designing production processes with quick connect single-use sterile connectors no longer experience the costs and delays associated with the extra time needed for open manual processes.

    Improving Gene Therapy Processes with CPC Aseptic Connectors

    • Broad chemical compatibility
    • Performance integrity down to -80°C
    • Sterilization by gamma or autoclaving methods
    • Reliable, repeatable performance
    • Validation reports available
    • Minimal operator training
    • Broad product portfolio from benchtop to cGMP production

    Achema-SterileConnectors-Rendering.1-update

    Secure and Sterile Connectors for Gene Therapy

    With the labor-intensive and open nature of gene therapy manufacturing, production is highly susceptible to operator error and contamination risks. CPC sterile connectors — attached to the single-use assembly — ensure a sterile, closed system process where each biologic drop is secure and sterile.

    Answers to Frequently asked Questions

    Single Use Technology for Gene Therapy

    CPC sterile aseptic connectors offer an easy-to-use method for flow path sterility and integrity during gene therapy manufacturing. These single-use connectors help deliver the necessary sterility protection to avoid costly failures from contamination.

    Where are Sterile Connectors Used For Gene Therapy

    Benefits of Sterile Connectors for Gene Therapy

    • Remove cumbersome steps in production
    • Minimize costs by closing operations that would normally be performed under the hood
    • Save time and labor during setup, production and between batches
    • Eliminate cross contamination in between batches
    • Reduce processing area footprint 

    Sterile Connectors for Gene Therapy: Decades of Experience, Forefront of Innovation

    CPC has been delivering aseptic connectors to the biopharmaceutical market for decades. With this extensive biopharma experience, CPC engineers have applied their single-use technology for gene therapy to sterile connector innovation. This laser-sharp focus directly led to CPC’s development of AseptiQuik®, Steam-Thru® and MicroCNX® Aseptic Connectors, exclusively designed and built for the complexities of upstream and downstream applications used in gene therapy processes.

    Get the Guide to Single-use Connectors

     

    Technical Insights from CPC's Biopharma Experts

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