Process Chromatography: Five Decades of Innovation - - BioPharm International


Process Chromatography: Five Decades of Innovation

BioPharm International
Volume 20, Issue 10

25. Janson JC, Hedman P. Large-scale chromatography of proteins. Adv Biochem Eng. 1982;25:43–99.

26. Low D. Scale-up of protein chromatographic separations. In Hancock WS (Ed). High performance liquid chromatography in biotechnology. New York: J Wiley & Sons; 1990. pp. 117–169.

27. Jungbauer A. Chromatographic media for bioseparation. J Chrom A, 2005; 1065:3–12.

28. Bren L. The Road to the biotech Revolution; Highlights of 100 years of biologics regulation. FDA Consumer Magazine, Centennial Edition, 2006; Jan–Feb.

29. Builder SE, Garnick RL, Hodgdon JC, Ogez JR. Proteins and peptides as drugs: Sources and methods of purification. In Rehm HJ and Reed G (Eds) Biotechnology, Vol 3; Bioprocessing (Stephanopoulos, G, (Ed) Weinheim, Germany: VCH. 1989, pp. 58–73.

30. Root MA, Chance RE, Galloway, JA. Immunogenicity of insulin. Diabetes, 1972;21(2):657–660.

31. Walsh G. Therapeutic insulins and their large-scale manufacture. Appl Microbiol Biotechnol, 2005;67:151–159.

32. Novo Nordisk History, pp 8–9,, accessed Nov 2006.

33. Lasagna L. The biological revolution: Commercialization of the molecule. Research Mgmt Rev. 1987;1:5–13.

34. Barinaga M. Asilomar revisited: Lessons for today? Science 2000;287:1584–1585.

35. US Food and Drug Administration. Guidance for industry. Research involving recombinant DNA molecules. Rockville, MD;1976.

36. Gosse ME, Manocchia M. The first biopharmaceuticals approved in the United States: 1980–1994. Drug Info J, 1996;30:991–1001.

37. Approved Biotechnology Drugs, (accessed Nov 2006).

38. Reichert JM, Paquette C. Therapeutic recombinant proteins: Trends in US approvals 1982–2002. Curr Op Mol Therapeutics. 2003;5(2):139–147.

39. Walsh G. Pharmaceutical biotechnology products approved within the European Union. Eur J Pharm Biopharm. 2003;55:3–10.

40. Shankar G, Shores E, Wagner C, Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 2006; 24(6):274–80.

41. Pfund NE. The wheat from the chaff: The separations industry comes of age. Hambrecht & Quist, 1987.

42. Ehrenheim P. GE Healthcare presentation at bioLOGIC Asia, Mumbai, India, 2006;Nov 28–29.

43. Sofer GK, Nyström LE. Process chromatography. A practical guide. London: Academic Press; 1989.

44. Sofer GK, Nyström LE. Process chromatography. A guide to validation. London: Academic press; 1991.

45. Feldman F. Production of proteins for replacement therapy: plasma or recombinant? IBC Conference: Biological safety and Production, Boston, 1999.

46. Jungbauer A, Boschetti E. Manufacture of recombinant proteins with safe and validated chromatographic sorbents. J Chrom B. 1994;662:143–179.

47. Chase HA. Purification of proteins by adsorption chromatography in expanded beds. Trends Biotechnol. 1994;12(8):296–303.

48. Noel R. EBA for industrial scale protein isolation. Recovery of biological products XII. Arizona, 2006;Apr 2–7.

49. Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerheim D, Vanderlaan M, Blank GS. Industrial purification of pharmaceutical antibodies: development, operation, and validation of chromatography processes. Biotechnol Genet Eng Rev. 2001;18:301–327.

blog comments powered by Disqus



First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International,
Click here