Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies - An alternative to the hybridoma method is producing engineered antibody molecules and fragments

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Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies
An alternative to the hybridoma method is producing engineered antibody molecules and fragments by in vitro methods.


BioPharm International
Volume 20, Issue 7

35. http:// http://www.emea.eu.int/humandocs/Humans/EPAR/synagis/Synagis.htm [Accessed 2005 Oct 15].

36. http:// http://www.ebra.org/ebrabulletin-ecvam-report-monoclonal-antibody-production_76.htm [Accessed 2005 Sept 22].

37. http:// http://www.emea.info/humandocs/Humans/EPAR/leukoscan/leukoscan.htm; [Accessed 2005 Sept 23].

38. http:// http://www.emea.info/humandocs/PDFs/EPAR/Ceascan/041296en6.pdf; [Accessed 2005 Sept 22].

39. Marx U, Embleton MJ, Fischer R. Monoclonal antibody production. The report and recommendations of ECVAM workshop 23. 1997 ATLA 25:121-135.

40. Werner RG. The development and production of biopharmaceuticals. Bioprocess International 2005 Supplement to Vol. 3; 9:6-15.

41. http:// http://www.emea.eu.int/humandocs/Humans/EPAR/enbrel/enbrel.htm [Accessed 2005 Oct 11].

42. http:// http://www.emea.eu.int/humandocs/Humans/EPAR/humira/humira.htm; [Accessed 2005 Oct 14].

43. http:// http://www.emea.eu.int/humandocs/Humans/EPAR/herceptin/herceptin.htm; [Accessed 2005 Oct 15]

44. http:// http://www.preclinica.com/content/articles/frame.asp?issue=0304&article=12; [Accessed 2006, Oct 12]


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