Aseptic connections enable successful use in small aseptic processes

As targeted cell and gene therapies gain more share in today's healthcare landscape, small-batch aseptic processes have become an integral part of
producing these precision medicines.
This shift, combined with downstream filtration challenges and the closed aseptic process that was widely promoted early in upstream development, has prompted manufacturers to re-evaluate how to optimize the sterility
of the entire process.
One of the key factors in achieving a closed aseptic process is the implementation of aseptic connections (maintaining the integrity of the fluid path from start to finish), focusing on those system connection points
that may be susceptible to contamination during the connection of two systems.
In traditional low-volume applications, these connections are supported by manual, open processes
.
Examples include quick connect and Luer fittings, which require connections under a laminar flow hood, or pipe welding, which uses heat to fuse open pipe ends together to form a sterile connection
.
Piping welding requires its own dedicated equipment and power supply, which can create space and time constraints that become more cumbersome
as producers ramp up production.
While traditional biopharmaceutical applications employ more processes around closed systems using sterile connectors, cell and gene therapy has been slower
to adopt these processes.
Because these modalities are still relatively new and unknown to some, many cell and gene therapy processes still employ tubing soldering or open connections, not yet disposable sterile connections
.
While sterile sterile connectors have been widely used in larger aseptic process applications, it is only recently that ultra-compact sterile connectors are available for closed small volume (<10L) processes
.
Their use in low-volume processes has begun to gain wider adoption, mainly due to the time and cost savings
that these connectors represent.
As autologous cell therapies and other targeted gene therapies scale to commercial levels, connectors that can be replaced in seconds, rather than the minutes typical of traditional joining processes, are a clear advantage
for industry.