- TRUE HUMAN™
- CORPORATE STRATEGY
XBiotech is using cutting-edge “low technology” to build a commercial drug production platform.
Our manufacturing program involves a disposable bioreactor concept and a largely disposable downstream process. The disposable “bioreactor” is a single use container, essentially a large plastic bag, which is used to contain growth media. Cells suspended in the growth media proliferate and secrete antibody, which can then be harvested and purified for use in preparation of a drug product.
The plastic bags used as bioreactors are sterilized for use and are simply discarded after harvest. Other components of the manufacturing process are also disposable. These include many “downstream” systems used in the antibody purification. This simple bioreactor system and other disposable components translate into minimal plant infrastructure and dramatically less capital costs and staffing. We also believe that it results in a more reliable production process with less risk of failure.
Simple, disposable technology, together with in-house engineering, dramatically reduces capital requirements and go-forward infrastructure and operational complexities, compared to conventional processes using stainless steel bioreactors.
We have now established a scalable and dynamic manufacturing capability. The bioreactor systems we are using permit seamless and continuous production scale-up, from clinical study programs to market. The flexibility, scalability and low infrastructure requirements allow us to move as quickly and efficiently as possible to transition from clinical programs, to commercial launch of our products—and to set up production systems virtually anywhere in the world where there is demand for biological drugs.
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