Housing 14 times 2,000L single-use bioreactors provided by Thermo Fisher, WuXi Biologics describes its $150m facility in Wuxi City, Jiangsu, as the world’s largest mammalian cell culture manufacturing site using disposable systems.
But the firm is increasing capacity by installing the largest available single-use bioreactors at the site: 4,000L Custom Single Run (CSR) disposable bioreactors from ABEC. Through the configuration of six bioreactors together, the site will be able to offer commercial volumes of 24,000L in a single, disposable run.
According to Chris Chen, CEO of WuXi Biologics, the investment is not due to a specific client but rather future demand.
“This is a WuXi initiated development to potentially enable 24,000L run using disposables, making it comparable to large scale stainless,” he told this publication.
“Each batch can produce 4-20kg,” he continued, adding the systems will be operational by April 2019.
Bethlehem, Pennsylvania-headquartered ABEC spokesperson Susan Cooper-Curcio told this publication: "WuXi’s selection, as well as our activities with other customers, further validates the industry’s need for flexible and scalable solutions as customers look to transition single-use technology from R&D and clinical applications to cost-effective commercial manufacturing or approved products."
Smashing the plastic ceiling
The time-saving and reduced contamination risk benefits of single-use bioreactors are well documented, but a major criticism made by end-users – including Pfizer and Janssen – concerns their limited scale for commercial production, compared to the 15,000L, 20,000L and beyond capacity of stainless steel tanks.
2,000L is considered a ceiling for single-use bioreactor bags due to the significant pressure from the increased weight of the liquid medium in larger volume bags, coupled with the significant learning curve for an end-user to manage.
However, ABEC launched a 4,300L bioreactor (with 3,500L of working volume) in 2015 and the 4,900L system (with a 4,000L working volume) last year.
According to the firm, these systems overcome the pressure issues due to “simple support structures at the lower ports.”