The importance of quality in biotechnology: The first biosimilar of EPO;L'importance de la qualité en Biotechnologie: le cas du 1er biosimilaire de l'EPO

Nephrologie et Therapeutique

Volumn 5, Issue SUPPL. 1, 2009, Pages 10-15

  Le Cotonnec, J Y ^a   Lawny, F ^a  

^a Triskel Integrated Services   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BINOCRIT; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ARTICLE; BIOLOGICAL ACTIVITY; BIOTECHNOLOGY; DRUG STRUCTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHARMACODYNAMICS; PHYSICAL CHEMISTRY;

AMINO ACID SEQUENCE; BIOTECHNOLOGY; ERYTHROPOIETIN; ERYTHROPOIETIN, RECOMBINANT; EUROPE; HUMANS; MOLECULAR SEQUENCE DATA; RECEPTORS, ERYTHROPOIETIN; THERAPEUTIC EQUIVALENCY;

EID: 60849086492     PISSN: 17697255     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1769-7255(09)70060-4     Document Type: Article

References (5)

1. Brockmeyer C, Seidl A. Binocrit. Quality by design. A standard approach to the assessment of quality, safety and efficacy of biopharmaceuticals following the hospital pharmacists's checklist. EJHP Practice 2008 [in press].
2. Gilg D., Riedl B., Zier A., and Ziemmermann M.F. Analytical methods for the characterization and quality control of pharmaceutical peptides and proteins, using erythropoietin as an example. Pharm Acta Helv 71 (1996) 383-394
3. Erslev A.J., and Beasarab A. Erythropoietin in the pathogenesis and treatment of the anemia of chronic renal failure. Kidney international 51 (1997) 622-630
4. ®. EMEA scientific discussion and summary of product characteristics. Accessed at: http://www.emea.europa.eu/humandocs/Humans/EPAR/binocit/binocrit.htm
5. Covic A., Cannata-Andia J., Cancarini G., Coppo R., Frazão J.M., Goldsmith M., et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know-a position paper by the ERA-EDTA Council. Nephrol. Dial Transplant 23 (2008) 3731-3737