Abstract
rAHF-PFM, the first third-generation recombinant Factor VIII concentrate, has been under clinical evaluation since November, 2000. No materials of human or animal origin are used in the production and final formulation of rAHF-PFM. To achieve this, the cell culture used to produce Recombinate, a preparation that has proven safety and efficacy for more than a decade, has been adapted to a protein-free medium. The monoclonal antibodies employed for immunoaffinity chromatography are produced in a protein-free medium, i.e. without the addition of any human- or animal-derived materials as well.
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© 2004 Springer-Verlag Berlin Heidelberg
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von Depka Prondzinski, M., Tiede, A. (2004). Phase III Clinical Evaluation of rAHF-PFM Prepared Using a Plasma/Albumin Free Method. In: Scharrer, I., Schramm, W. (eds) 33rd Hemophilia Symposium. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-18260-0_19
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DOI: https://doi.org/10.1007/978-3-642-18260-0_19
Publisher Name: Springer, Berlin, Heidelberg
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