The Company was founded around the mission to develop a next generation of better, safer therapeutic antibodies. As the biopharmaceutical industry scrambled to advance technologies to engineer therapeutic antibodies, the use of natural human antibodies as therapeutics remained largely unexplored. The discovery and commercialization of natural or True Human™ antibody therapeutics was therefore a quantum advance for medicine, and a significant business opportunity. After years of innovation and dedicated research, XBiotech scientists have established a remarkable discovery engine for True Human™ antibody therapeutics.
The advance of better tolerated antibody therapeutics will expand existing markets and open up vast new ones. Thus affordability of these drugs is key to seizing burgeoning (global) market opportunities. Therefore in 2008, XBiotech began to develop manufacturing technology to produce biologics with reduced infrastructure needs.
Standard industry processes for manufacturing were too costly and excessively complex to reengineer. These biomanufacturing plants required huge, capital-intensive infrastructure, including bioreactor systems of bewildering complexity. The timelines to establish these facilities, and the work force needed to run and maintain them were excessive. New thinking was necessary.
Fortunately, the ability to greatly simplify manufacturing approaches, using some innovation but with largely existing technology, seemed achievable. XBiotech set out with a minimalist philosophy, free of preconceptions, to build a new manufacturing process. The idea was to build a complete manufacturing system that was simple, robust and as capital friendly to build as it was affordable to operate. Ultimately, it involved designing and building disposable bioreactor systems that are so durable they almost never need servicing; and creating a purification process that facilitates such high product recovery that it is perhaps the most efficient in the industry. The result has been to establish a manufacturing process that realizes: (1) dramatic reduction in capital requirements; (2) shorter lead times; (3) simpler quality compliance; and (4) unprecedented production flexibility compared to industry standard manufacturing systems of today. In the end, we not only reached our target, but went well beyond cost of goods expectations and created a whole new way of building a biopharmaceutical company.
Today, XBiotech is equipped to establish a new paradigm in the biopharmaceutical industry-develop breakthrough biological therapies with unprecedented flexibility and cost efficiency.
Typical Clean-in-Place Stainless Steel Bio-Reactor System (upper left and below). An example of simple, disposable 1,000L bioreactor systems used by XBiotech (upper right). The capital costs for constructing a manufacturing facility with stainless bioreactor systems is many many times greater than the cost of a similar output disposable reactor facility. Moreover, maintenance and operation of the stainless bioreactor plant is more complex and requires a larger, highly trained workforce compared to the disposable system. The row of complex reactors (below) have about the same production capacity as a single plastic bag reactor shown operating on the XBiotech manufacturing floor.