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Innovative approach for improved r FVIII concentrate
Author(s) -
Morfini Massimo
Publication year - 2014
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12359
Subject(s) - chinese hamster ovary cell , immunogenicity , recombinant dna , antigenicity , biosimilar , glycosylation , affinity chromatography , size exclusion chromatography , downstream processing , clone (java method) , chemistry , antibody , virology , biochemistry , medicine , immunology , biology , receptor , microbiology and biotechnology , enzyme , gene , dna
The development of a new recombinant factor VIII was designed and implemented to answer a number of unmet needs of patients affected by hemophilia A . Turoctocog alfa is bioengineered in a specific Chinese hamster ovary clone to present translational and posttranslational characteristics (sulphation, glycosylation) biosimilar to natural circulating forms of FVIII , with the aim to devoid any minimal change which may impact immunogenicity and antigenicity of recombinant protein. Both producer cell line and media are maintained free of any animal or human plasma derivative. Downstream processes of purification are performed by five steps (immunoaffinity chromatography, ion‐exchange chromatography, virus inactivation by means of solvent‐detergent treatment and nanofiltration, and to end with gel filtration), to provide the best possible margin of safety from known and unknown infectious agents. Large clinical trials seem to confirm the expectations placed in T uroctocog alfa in terms of high quality and safety of recombinant FVIII toward the goal of overcoming actual and future challenges of hemophilia therapy.