The manufacturing process for HEMLIBRA is as rigorous as the scientific research. Learn more about the collaborative process of discovering, developing, and manufacturing HEMLIBRA below.

Discovering HEMLIBRA

Researchers studying treatments for hemophilia A had an idea to use an antibody to play a possible role in the clotting process. Antibodies are a natural part of the immune system that protect the body from harm.  Researchers hypothesized that a specifically designed antibody, called a therapeutic antibody, may be able to connect key proteins in the coagulation cascade to perform the function of the missing factor VIII. 

Because an antibody is not the same as factor VIII, researchers theorized that this antibody could be used in people with inhibitors to factor VIII.

After almost 10 years and trying 40,000 different therapeutic antibodies to find a match, HEMLIBRA was discovered as a possible antibody for clinical trials.

Developing HEMLIBRA

  • Scientists then modified the therapeutic antibody with the goal of making it more similar to ones that are normally produced in humans (humanized)
  • The researchers also modified the therapeutic antibody to affect its movement through the body and ability to stay in the body (pharmacokinetics)
  • Lastly, the antibody went through a purification process to remove unwanted substances

Manufacturing a therapeutic antibody

HEMLIBRA is a therapeutic antibody manufactured with biotechnology using the Chinese hamster ovary (CHO) cell line. 

Like the discovery and development stages, manufacturing a therapeutic antibody is also a rigorous scientific process. It’s an exacting process that involves hard work from thousands of dedicated people.

When therapeutic antibodies like HEMLIBRA are made in a laboratory using biotechnology,  there are multiple, controlled purification steps taken to produce and purify, or clean, the therapeutic antibody and remove unwanted substances.

Manufacturing process

HEMLIBRA doesn’t contain human plasma or human blood components. 

HEMLIBRA does not come from human blood. Human plasma and human blood components are not used in the manufacturing of HEMLIBRA.

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A treatment option for hemophilia A with or without factor VIII inhibitors