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    Single-Use Technology for Monoclonal Antibodies

    Biologic drugs based on monoclonal antibodies (mAbs) have seen a growing number of approved products due to their effectiveness in combating diseases including cancer, autoimmune diseases and rheumatoid arthritis. Opportunities for increased production of monoclonal antibodies in turn increases competition within the biopharmaceutical industry. The growing demand and increased competition for these biologic treatments requires even greater efficiencies in R&D and manufacturing. 

    Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

    Food and Drug Administration Covid 19 Update Press Release

    Shortened Time to Market Drives Process Improvements

    Sophisticated monoclonal antibody production systems help drive accelerated times to market to get the therapeutic treatment to the patient. These increasingly complex systems demand process development that support a rapid transition to full scale production. The development and production of mAbs have a major influence on single use bioprocessing systems market growth.

    mAb Systems Criteria

    • Deliver enhanced design flexibility
    • Adapt quickly to new operating conditions
    • Able to scale
    • Easily transferable to various manufacturing facilities
    • Offer effective handling of media substances
    • Yield increased cost-effectiveness
    • Support robust single-system technologies
    • Support wide variety of bioreactors including microbioreactors, benchtop and production bioreactors

    Growing Demand for Single-Use Technology (SUT) in Biopharma

    With ongoing Covid-19 vaccine R&D activities and clinical studies, a majority of bioprocessing manufacturing companies depend on single-use systems to develop, produce and get mAbs to the market faster. Additionally, the growing number of monoclonal antibody therapeutic products being developed and produced for the diagnosis and treatment of autoimmune disorders, cancer and other infections is furthering the single use bioprocessing market growth.

    Single-Use Technologies Offer a Wide Range of Benefits in Pharmaceutical Manufacturing

    • Enhanced scalability 
    • Mitigate contamination risk preventing resource waste and improving yield 
    • Higher degree of flexibility process design 
    • Ability to fit existing, validated production processes
    • Significant potential for cutting overall system costs
    • Increased capacity and productivity from small-batch to large-batch volumes
    • Easy to use and maintain

    CPC Expertise in Monoclonal Antibody Media Transfer

    CPC’s extensive experience and expertise in media transfer solutions help you design the right monoclonal antibody media transfer solution for single-use systems as well as traditional manufacturing. Our team collaborates with your bioprocessing professionals to help optimize your processes, transition to commercial-scale production and help shorten your time to market. CPC’s design and application engineers understand bioprocessing materials, upstream and downstream application processes and clean room production to identify the right media transfer connector solution for your SUS manufacturing. 

    AseptiQuik® Connectors for Improved Media Transfer Production

    It’s critical for biopharma companies and laboratories to design the optimal fluid pathway but it’s an often-overlooked component of a SUS. CPC AseptiQuik Sterile Connectors help establish critical media transfer links for achieving monoclonal antibody production accurately, timely, and cost-efficiently.

    Biopharma companies use AseptiQuik sterile connectors to produce monoclonal antibody treatments that require aseptic connections to be produced in any production environment. Selection of the single-use connection technology can have serious implications on the scalability, reproducibility and security of the process. AseptiQuik Sterile Connectors provide on-the-fly changes or additional monitoring during cell culture by offering a tool for making secure aseptic connections that are quick and easy to use, even in non-sterile environments.

    • Genderless connectors with multiple terminations 
    • Single-use connectors designed for small-scale and large-scale production
    • Robust construction
    • Easy to use with reliable performance 
    • No additional hardware required

    How AseptiQuik Sterile Connectors Help Monoclonal Antibody Production

    • Lightweight, cost-effective sterile connections 
    • Withstand pressures in high vibration applications
    • Simple three-step connection
    • Eliminate incompatible connections
    • Widest range of genderless connectors on the market
    • Works with wide range of tubing types
    • Allow connection in hard-to-reach area
    • Aseptic connections in uncontrolled environment
    • Mitigate cross contamination risk

    AQG-beauty

    Insight from CPC Bioprocessing Experts

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