Moving Ahead With Single Use Technology

By Richard Bhella, Director of Applications, ATMI Life Sciences

Single-use technologies have gained a significant foothold in the bioprocessing market over the past decade. They have proven to deliver tangible benefits in bioresearch and biomanufacturing, with applications ranging from simple storage, through mixing to bioreactors, and at production scales up to 3,000 liter. But why has the market taken to single-use so readily, and what challenges remain?

End-users have done their part too by leveraging the considerable body of experience with single-use technologies to implement superior operator training and process SOPs that are optimized for single-use systems.

 Lastly, innovations like ATMI’s Helium Integrity Testing technology mean previously undetectable pinholes that compromise sterility can be found, and the defective part replaced, before product is lost and – even more importantly – before patient health is put at risk.

 Scalability remains a concern. The largest practical size for single-use bags caps out at around 3000L, and even this size is way off the end of the bell curve in terms of usage. Above 3000L, stainless is still king, but it rules over a shrinking domain; growing productivity and ever higher titers mean that scalability is no longer in the forefront of users’ minds.

 Perhaps the biggest issue still facing single-use technology is the lack of standardization of critical proprietary parts from different suppliers. Plastics used for product contact are becoming more and more aligned, meaning there is less and less to choose between them from a leachables and extractables perspective. However, it's a very different story for connectivity between different vendors’ equipment, which can come with a bewildering array of different aseptic couplings and tubing. The market is unanimous in calling for this to be resolved; users want to be able to pick and choose the best “standard” components, and use them in ever more flexible ways, without having to go down the custom assembly route with all its attendant lead time, cost and reliability implications. To their credit, the single-use vendors are listening.