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Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein
Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and...
Autores principales: | McCue, J, Osborne, D, Dumont, J, Peters, R, Mei, B, Pierce, G F, Kobayashi, K, Euwart, D |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282370/ https://www.ncbi.nlm.nih.gov/pubmed/24811361 http://dx.doi.org/10.1111/hae.12451 |
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