Manufacturing

XBiotech is using cutting-edge “low technology” to build a commercial drug production platform.

Our manufacturing program involves a disposable bioreactor concept, in-house designed bioreactor platforms, 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 come pre-sterilized and are simply discarded after use. 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 contamination.

Simple, disposable technology, together with in-house engineering, dramatically reduces capital requirements and go-forward infrastructure and operational complexities, compared to conventional processes centered around clean-in-place, stainless steel bioreactor technology.

We have now established a scalable and dynamic manufacturing capability. The 500L 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 allows us to move as quickly and efficiently as possible to transition from clinical programs, to commercial launch of our products and beyond.

XBiotech is planning construction of its first commercial scale manufacturing facility. The planned new facility would be capable of operating a total capacity of 25,000L, with an annual total output of about 2,000,000 doses. This facility would be capable of launching XBiotech’s lead product candidate into the global market place.