Maintaining Aseptic Processes Using Small-Volume, Closed Systems

As targeted cell and gene therapies gain more ground in today’s healthcare landscape, small-batch aseptic processing has become integral in producing these precision medicine treatments. 

This shift, coupled with downstream challenges and a widespread push to close aseptic processes earlier in upstream development, has forced manufacturers to reevaluate how to optimize sterility throughout the process. 

One of the key factors in enabling closed aseptic processes is with sterile connections – maintaining the integrity of a fluid path from start to finish – requires a focus on those points of connection between systems that may be susceptible to contamination during the joining of two systems. Traditionally, in small batch applications, these connections have been supported through manual, open processes such as quick connect and luers, which require connections to be completed under laminar flow hoods, or tube welding, which uses heat to fuse open tubing ends together to create a sterile connection. 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.

Image c/o CPC

While many traditional biopharma applications have begun closing systems by utilizing sterile connectors, the cell therapy and gene therapy space has not yet fully embraced closed end-to-end systems, typically opting for open connections or tube welding. As these newer therapies continue to move forward and scale up, users should evaluate the value of closing the process from end to end. Considerations for this change should include minimizing contamination risk, securing documented and validated processes, simplifying training, enabling consistency, and enhancing speed-to-market by creating quicker connections in line.

Whether talking about traditional biopharma, cell therapy, or gene therapy applications, ultra-compact sterile connectors were not available for closed, small-volume (<10L) processes until the recent launch of the MicroCNX® aseptic connector. This small-volume connector features a simplified “pinch-click-pull” installation: users pinch to remove the connector’s protective cover, click its two halves together, and pull out the protective membranes to allow flow to move through the connector. 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 related performance and reliability concerns. 

Small format connectors used in small-batch processes will likely experience 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.  

Interested in the time, cost, and safety considerations of aseptic connections? And how to streamline and accelerate your aseptic process with single-use connectors?  Read the full article here.