This article describes and demonstrates the performance of a novel disposable culture platform, the rolling tube, which we have developed, tested, and found superior, in many aspects, compared with current platforms being used in process development applications such as media screening and clone selection. The rolling-tube platform provides a balance between throughput and scale or volume (necessary to perform analytical assays); it also is robust, easy to set up, and ergonomic to use, as well as versatile, saving time and money. Importantly, results obtained with this system are applicable to larger platforms used in commercial production. This platform is now being implemented in our laboratories in California and Europe.
The volume of the 2-L roller bottles is not large enough to allow purification and a comprehensive characterization of the product or impurities. Smaller, low-cost platforms such as T-flasks and plate systems have advantages in throughput, space use, and ease of use while allowing for sufficient sample volume for analysis and being predictive of performance at large scale. In previous experiments, we have found that T-flasks performed similarly or even better than the large roller bottles (not shown). However, both flask and plate systems have drawbacks such as ergonomics and gas transfer and condensation problems resulting from their design combined with lower volume (especially multi-well plates) that can significantly affect culture performance. Therefore, we set out to develop a platform that would preserve the advantages of the traditional roller bottle along with those of the more advanced flask and plate systems. Here, we describe the performance of the roller tube platform compared to two small-scale platforms: T-flasks and 6-well plates.