Single-use bioprocessing is designed to be flexible, efficient, and effective in the manufacture of drug substances, monoclonal antibodies, vaccines, biosimilars, cell and gene therapies, and other modalities. Genderless, easy-to-use single-use connectors are a key tool in enabling this paradigm. By reducing system complexity, simplifying training requirements, and enabling rapid process conversion, these products help manufacturers accelerate their timelines.​

In contrast to both tube welding and laminar flow hood methodologies, connectors do not require any additional equipment or capital investment to integrate them into existing processes. The training needed to incorporate connectors in a system is minimal, as is the time needed to change connectors – roughly 15 seconds, compared to tube welding, which can take more than a minute for a trained operator to complete. This time savings is another factor that, when applied to thousands of changeovers, creates attractive economies of scale for manufacturers.​

Tube welding requires its own dedicated equipment and power source, which can impose space and time constraints that become more cumbersome as manufacturers ramp up production. While traditional biopharma applications have adopted more processes centered around closing of systems utilizing sterile connectors, the cell therapy and gene therapy have been slower to adoption of those processes. As these modalities remain relatively new and less known to some, many cell and gene therapy processes still employ tube welding or open connections; not yet adopting single-use aseptic connections.

While sterile aseptic connectors have been widely adopted in larger aseptic processing applications, ultra-compact sterile connectors were not available for closed small volume (<10L) processes until recently. Their use in small-batch processes has begun to experience more widespread adoption, largely due to the time and cost savings these connectors represent: as autologous cell therapies and other targeted gene therapies work to scale up to commercial levels, connections that can be changed out in seconds, rather than in the minutes typical of traditional connection processes, represent a distinct advantage for industry. Their ease-of-use, one-time validation, and flexibility in integrating with existing processes make single-use aseptic connectors ideal for use in challenging bioprocessing and personalized medicine conditions.​

This process offers a stark contrast to tube welding, which requires at least a dozen steps, access to electricity, routine equipment maintenance, and comparatively extensive training. It also allows manufacturers to maximize their cleanroom space by eliminating the need for multiple welders and the space required to maneuver them. The MicroCNX connectors’ intuitive, simplified connection process also helps reduce the risk of operator error, minimizing the related operator performance and reliability concerns. CPC, a global leader in single-use connection technology, has pioneered the MicroCNX series in response to a burgeoning need for more reliable aseptic connection techniques in small-volume processing.​