References
- FDA guidance on demonstration of comparability of human biological products, including therapeutic biotechnology derived products, CDER/CBER, 1996
- Guideline on comparability of medicinal products containing biotechnology-derived protein as active substances, CPMP/BWP/3207/00, 2001
- Guideline on similar biological medicinal products, CHMP/437/04, 2005
- Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, EMEA/CHMP/BMWP/14327/2006, 2007
- Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues, EMEA/CHMP/BWP/49348/2005, 2006
- Comparability of biotechnological/biological products subject to changes in their manufacturing process, ICH Q5E, 2005
- Specifications: test procedures and acceptance criteria for biotechnological/biological products, ICH Q6B, 1999
- Schellekens H. Bausch J. Biopharmaceutical molecules are not created equally. Pharm J 2002;268:300-1
- Sharma B. Immunogenicity of therapeutic proteins. Part 2: Impact of container closures. Biotechnol Adv 2007;25:318-24
- Purohit VS, Middaugh CR, Balasubramanian SV. Influence of aggregation on the immunogenicity of recombinant human Factor VIII in hemophilia A mice. J Pharm Sci 2006;95:358-71
- Boven K, Stryker S, Knight J, et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005;67:2346-53
- Peerlinck K, Arnout J, Di Giambattista M, et al. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 1997;77:80-6
- Schellekens H, Jiskoot W. Eprex-associated pure red cell aplasia and leachates. Nat Biotech 2006;24:613-4
- Schellekens H. Assessing the bioequivalence of therapeutic proteins. The Retacrit® case. Drug Discov Today 2009: doi:10.1016/j.drudis.2009.02.003
- WHO Drug Information Vol 22, 2008
- Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMEA/CHMP/BMWP/42832/2005, 2006
- Bray BL. Large-scale manufacture of peptide therapeutics by chemical synthesis. Nat Rev Drug Discov 2003;2:587-93
- Bruckdorfer T, Marder O, Albericio F. From production of peptides in milligram amounts for research to multi-tons quantities for drugs of the future. Curr Pharm Biotechnol 2004;5:29-43