Gene Therapies: A Guide To Aseptic Single-Use Connectors

By Amber Sherrick, Market Manager, Biopharma and Derek Pendlebury, Director of Sales, Biopharma, Colder Products Company

While the number of cell & gene therapies in the pipeline hold much promise, it is important to evaluate your manufacturing process and gauge if improvements can be made to your efficiencies, aseptic conditions and timelines. Even components such as connectors can have a big impact on your productivity and quality.

There are many lessons to learn from traditional biologics like vaccines and mAbs as they have been early adopters of aseptic connectors and single-use technologies (SUT) overall.

There is a wide range of processing technologies for connectors, they can be supplied as either discrete components or more often as pre-validated, presterilized single-use systems – ready to open and use. They are used to connect single-use fluid paths – these fall into two basic categories based on how the connection is achieved: those that connect by welding or fusing together two fluid paths and those that mechanically couple two components installed in the fluid pathway.

You might ask, how should you determine if you should use a tube welder or a connectors. In this article, we will explain environments where a tube welder option will work and situations where an aseptic connector is the better option as well as explain the differences and benefits of both a gendered and genderless connector.