The manufacturing process for recombinant factor IX.
Semin Hematol
; 35(2 Suppl 2): 4-10, 1998 Apr.
Article
de En
| MEDLINE
| ID: mdl-9565160
ABSTRACT
Advances in recombinant DNA manufacturing technology have now made possible the production of a highly purified and active recombinant factor IX (rFIX) product. Recombinant factor IX was developed by (1) stable insertion of the genes for both factor IX and PACE-SOL (a truncated, soluble serine protease needed to enhance the capacity of cells to remove the amino-terminal propeptide from rFIX) into Chinese hamster ovary cells; (2) selection of a cell line that was capable of expressing high amounts of active rFIX while growing in bioreactors containing a completely defined culture medium that does not contain blood or plasma products; and (3) inclusion of four independent chromatography steps, none of which require monoclonal antibodies. Furthermore, rFIX has been extensively tested to demonstrate similarity to plasma-derived factor IX and has been shown to be a consistent, high-purity product. For example, a high-specific-activity product (276+/-23 IU/mg) has been consistently produced throughout 65 consecutive batches from five consecutive manufacturing campaigns. Thus, rFIX offers a consistent and high-purity source of factor IX treatment for patients with hemophilia B.
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Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Facteur IX
Limites:
Animals
/
Humans
Langue:
En
Journal:
Semin Hematol
Année:
1998
Type de document:
Article
Pays d'affiliation:
États-Unis d'Amérique