WHAT ARE TRUE HUMAN™ ANTIBODIES?
True Human™ antibodies, as the name implies, are simply those that are derived from a natural antibody identified from the blood of an individual.
At XBiotech, we believe that cutting-edge medicine should work in a targeted way to make patients feel better and help restore quality of life without worry of side effects. Through True Human™ technology, we want to be pioneers in the way the world looks at biopharmaceutical technology and production.
We have established a Start-to-Finish monoclonal antibody production platform. From the construction of Production Cell Banks to the Aseptic Fill of Vials and Pre-filled Syringes, all production processes are performed on-site in our manufacturing facility utilizing disposable single use systems.
Our production platform allows for the rapid scale-up of new investigational molecules and their associated cGMP processes, while our talented and experienced multi-disciplinary manufacturing team leads the finalization in process design, implements continuous process development, and generates clinic-ready production batches.
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Industry Context
Marketed antibodies to date, described as “Fully Human”, are not derived from human gene sequences that have undergone the crucial process of selection in a human. Without exception, all marketed products to date that are described as “Fully Human”, are in fact engineered and are not selected based on natural tolerance in the human body. The use of the term “Fully Human” to describe these products has thus created considerable confusion.
manufacturing
The clean-room environment (meets ISO 14644-1:2015 Class 7 and Class 5 air quality standards) is 20,442 square feet with 18,537 square feet of manufacturing support areas including controlled-access raw materials receiving/quarantine area, a controlled-access released goods storage and quality control and microbiology laboratories.
Modern medicine should help patients feel better, not worse. At XBiotech, we believe in the Hippocratic principle of "do no harm." We believe this is inherent to the innovative True Human™ antibody medicines we are developing. True Human™ antibodies move beyond the idea that effective medicines must come with toxicity or harmful side effects.
By utilizing the body’s natural immune system, XBiotech develops therapies that help you heal and feel better.
