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Safety Record

  1. Human gene for factor VIII isolated
  2. The portion of the factor VIII gene encoding the B-domain is deleted
  3. B-domain-deleted recombinant factor VIII (BDDrFVIII) gene inserted into production cell (Chinese hamster ovary cells)
  4. Production cells grown in culture media that contain small amounts of human serum albumin
  5. Production cells frozen and stored
  6. Production cells taken from cell bank and thawed
  7. Production cells grow inside bioreactors with human serum albumin in the culture medium
  8. ReFacto is filtered away from production cells and then purified and concentrated by a chromatography step
  9. ReFacto is processed through a solvent-detergent viral inactivation step
  10. ReFacto is processed through monoclonal antibody purification and 3 more chromatography steps
  11. ReFacto is then freeze-dried and packaged, and no albumin is added to the final product

The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.


   
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