Production and downstream processing of biotech compounds

Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition

Volumn , Issue , 2016, Pages 49-65

  Kadir, Farida ^a   Hamers, Mic ^b   Ives, Paul ^b  

^a Postacamedic Education Pharmacists (POA)   (Netherlands)

^b SynCo Bio Partners BV   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85051806423     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (65)

1. Afeyan N, Gordon N, Mazsaroff I, et al. (1989). Flowthrough particles of the high-performance liquid chromatographic separation of biomolecules, perfusion chromatography. J Chromatogr 519:1-29.
2. Arathoon WR, Birch JR (1986). Large-scale cell culture in biotechnology. Science 232:1390-95.
3. Benedek K, Swadesh JK (1991). HPLC of proteins and peptides in the pharmaceutical industry. In: Fong GW, Lam SK, eds. HPLC in the Pharmaceutical Industry. New York: Dekker, 241-302.
4. Berthold W, Walter J (1994). Protein purification: Aspects of processes for pharmaceutical products. Biologicals 22:135-50.
5. Borman S (2006). Glycosylation engineering. Chem Eng News 84:13-22.
6. Burnouf T, Dernis D, Michalski C, Goudemand M, Huart JJ (1989). Therapeutic advantages of a high purity plasma factor IX concentrate produced by conventional chromatography. Colloque Inserm 175:25-334.
7. Burnouf-Radosevich M, Appourchaux P, Huart JJ, Burnouf T (1994). Nanofiltration, a new specific virus elimination method applied to high-purity Factor IX and Factor XI concentrates. Vox Sang 67:132-8.
8. Cartwright T (1987). Isolation and purification of products from animal cells. Trend Biotechnol 5:25-30.
9. Chase HA (1988). Adsorption preparation processes for protein purification. In: Mizrahi A, ed. Downstream processes: Equipment and techniques, Vol. 8. New York: A.R. Liss, 163-312.
10. Chase HA (1994). Purification of proteins by adsorption chromatography in expanded beds. Tibtech 12:296-303.
11. Chase H, Draeger N (1993). Affinity purification of proteins using expanded beds. J. Chromatogr 597:129-45.
12. Christensen T, Dalboge H, Snel L (1990). Postbiosynthesis modification: Human growth hormone and insulin precursors. In: Drug Manufacture, Part IV.
13. Cumming DA (1991). Glycosylation of recombinant protein therapeutics: Control and functional implications. Glycobiology 1(2):115-30.
14. European Agency for the Evaluation of Medicinal Products (EMEA, 1997), Human Medicines Evaluation Unit. ICH Topic Q5D. Quality of biotechnological products:Derivation and characterisation of cell substrates used for production of biotechnological/biological products.
15. European Agency for the Evaluation of Medicinal Products (EMEA, 1999a). Note for guidance on minimising the risk of transmission of animal/spongiform encephalopathy agents.
16. European Agency for the Evaluation of Medicinal Products (EMEA, 1999b). Human Medicines Evaluation Unit. ICH Topic Q6B. Specifications test procedures and acceptance criteria for biotechnology/biological products.
17. European Pharmacopoeia (1997). 3rd ed. Strasbourg: Council of Europe.
18. FDA, Center for Biologics Evaluation and Research (1990) Cytokine and growth factor pre-Ppivotal Ttrial information Ppackage with special emphasis on products identified for consideration under 21 CFR 312 Subpart E, Bethesda, MD, USA.
19. FDA, Office of Biologicals Research and Review (1993) Points to consider in the characterization of cell lines used to produce biologicals, Rockville Rike, Bethesda, MD, USA.
20. Fulton SP (1994). Large scale processing of macromolecules. Curr Opin Biotechnol 5:201-5.
21. Garnick RL, Solli NJ, Papa PA (1988). The role of quality control in biotechnology: An analytical perspective. Anal Chem 60:2546-57.
22. Gottschalk U (2006). The renaissance of protein purification. BioPharm Int, June.
23. Heng M, Glatz C (1993). Charged fusions for selective recovery of b-galactosidase from cell extract using hollow fiber ion-exchange membrane adsorption. Biotechnol Bioeng 42:333-8.
24. Hippel von PH, Wong K-Y (1964). Neutral salts: The generality of their effects on the stability of macromolecular conformations. Science 145:577-80.
25. Hjerten S, Mohammed J, Nakazato K (1993). Improvement in flow properties and pH stability of compressed, continuous polymer beds for high-performance liquid chromatography. J Chromatogr 646:121-8.
26. Hodge G (2004). Disposable components enable a new approach to biopharmaceutical manufacturing. BioPharm Int 15:38-49.
27. Homma T, Fuji M, Mori J, Kawakami T, Kuroda K, Taniguchi M (1993). Production of cellobiose by enzymatic hydrolysis: removal of b-glucosidae from cellulase by affinity precipitation using chitosan. Biotechnol Bioeng 41:405-10.
28. Horowitz MS, Bolmer SD, Horowitz B (1991). Elimination of disease-transmitting enveloped viruses from human blood plasma and mammalian cell culture products. Bioseperation 1:409-417.
29. Horowitz B, Prince AM, Hamman J, Watklevicz C (1994). Viral safety of solvent/detergent-treated blood products. Blood Coagulation and Fibrinolysis 5:S21-8.
30. James AM (1992). Introduction fundamental techniques. In:James AM, ed. Analysis of Amino Acids and Nucleic Acids. Oxford: Butterworth-Heinemann, 1-28.
31. Jones K (1990). Affinity chromatography, A technology update. Am Biotechnol Lab 8:26-30.
32. Jungbauer A, Wenisch E (1989). High performance liquid chromatography and related methods in purification of monoclonal antibodies. In: Advances in Biotechnological Processes. New York, Liss, pp. 161-92.
33. Kamihira M, Kaul R, Mattiasson B (1993). Purification of recombinant protein A by aqueous two-phase extraction integrated with affinity precipitation. Biotechnol Bioeng 40:1381-87.
34. Klegerman ME, Groves MJ (1992). Pharmaceutical Biotechnology. USA: Interpharm Press, Inc.
35. Knight P (1990). Bioseparations: Media and Modes. Biotechnology 8:200.
36. Krueger JK, Kulke MH, Schutt C, Stock J (1989). Protein inclusion body formation and purification. Pharmaceut Technol Int, 48-51.
37. Kung VT, Panfili PR, Sheldon EL, et al. (1990). Picogram quantification of total DNA using DNA-binding proteins in a silicon sensor based system. Anal Biochem 187:220-7.
38. Liptrot C, Gull K (1991). Detection of viruses in recombinant cells by electron microscopy. In: Spier RE, Griffiths JB, MacDonald C, eds. Animal Cell Technology, Developments, Processes and Products. Oxford:Butterworth-Heinemann Ltd, 653-6.
39. Löwer J (1990). Risk of tumor induction in vivo by residual cellular DNA: Quantitative Considerations. J Med Virol 31:50-3.
40. Maerz H, Hahn SO, Maassen A, et al. (1996). Improved removal of viruslike particles from purified monoclonal antibody IgM preparation via virus filtration. Nat Biotechnol 14:651-2.
41. Marcus-Sekura CJ (1991). Validation and Removal of Human Retroviruses. Center for Biologics Evaluation and Research. Bethesda, MD: FDA.
42. Minton AP (1990). Quantitative characterization of reversible molecular associations via analytical centrifugation. Anal Biochem 190:1-6.
43. Minor PD (1994). Ensuring safety and consistency in cell culture production processes: Viral screening and inactivation. TIB TECH 12:257-61.
44. Nolan JG, McDevitt JJ, Goldmann GS (1975). Endotoxin binding by charged and uncharged resin. Proc Soc Exp Biol Med 149:766-70.
45. Note for Guidance (1991). Validation of Virus Removal and Inactivation Procedure, Ad Hoc Working Party on Biotechnology/Pharmacy, European Community, DG III/8115/89-EN.
46. Pearson FC (1987). Pyrogens and depyrogenation, theory and practice. In: Olson WP, Groves MJ, eds. Aseptic Pharmaceutical Manufacturing. Prairie View:Interpharm Press Inc.
47. Perret BA, Poorbeik M, Morell A (1991). Klinische prü fung von Premogfil M SRK, einem mit monoklonalen antikörpern hochgereinigten gerinningsfaktor VIIIKonzentrat aus humanplasma. Schweiz Med Wochenschr, 121:1624-7.
48. PDA Journal of Pharmaceutical Science and Technology (2005), Technical report No. 41, Virus Filtration, March/April, Vol. 59, No. S-2.
49. Ptitsyn OB (1987). Protein folding: Hypothesis and experiments. J Protein Chem 6:273-93.
50. Sadana A (1989). Protein inactivation during downstream separation, Part I: The processes. Biopharm 2:14-25.
51. Schindler R, Dinarello CA (1990). Ultrafiltration to remove endotoxins and other cytokine-inducing materials from tissue culture media and parenteral fluids. Bio Techniques 8:408-13.
52. Sharma SK (1990). Key issues in the purification and characterization of recombinant proteins for therapeutic use. Adv Drug Deliv Rev 4:87-111.
53. Sharma SK, Hopkins TR (1981). Recent developments in the activation process of bovine chymotrypsinogen. Bioorganic Chem 10:357-74.
54. Sinclair AM, Elliott S (2005). Glycoengineering: The effect of glycosylation on the properties of therapeutic proteins. J. Pharm.Sci 94:1626-35.
55. Strickler MP, Gemski MJ (1987). Commercial production of monoclonal antibodies. New York: Marcel Dekker, 217-45.
56. Tennikova T, Svec F (1993). High performance membrane chromatography: Highly efficient separation method for proteins in ion-exchange, hydrophobic interaction and reversed phase modes. J Chromatogr 646:279-88.
57. Terstappen G, Ramelmeier R, Kula M (1993). Protein partitioning in detergent-based aqueous two-phase systems. J Biotechnol 28:263-75.
58. Walter J, Werner RG (1993). Regulatory requirements and economic aspects in downstream processing of biotechnically engineered proteins for parenteral application as pharmaceuticals. In: Kroner KH, Papamichael N, Schü tte H, eds. Downstream Processing, Recovery and Purification of Proteins, A Handbook of Principles and Practice. New York:John Wiley Publishers Inc.
59. Walter J, Werz W, McGoff P, Werner RG, Berthold W (1991). Virus removal/inactivation in downstream processing. In: Spier RE, Griffiths JB, MacDonald C, eds. Animal Cell Technology: Development, Processes and Products. Linacre House, Oxford: Butterworth-Heinemann Ltd. 624-34.
60. Walter K, Werz W, Berthold W (1992). Virus removal and inactivation, concept and data for process validation of downstream processing. Biotech. Forum Europe 9:560-4.
61. Werner R (2005). The development and production of biopharmaceuticals: Technological and economic success factors. Bioprocess Int 3(9 Suppl):6-15.
62. Wheelwright SM (1993). Designing downstream processing for large scale protein purification. Biotechnology 5:789-93.
63. White EM, Grun JB, Sun C-S, Sito F (1991). Process validation for virus removal and inactivation. BioPharm 34-9.
64. World Health Organization (1998). Requirements for the use of animal cells as in vitro substrates for the production of biologicals (Requirements for Biological Substances No. 50). Technical Report Series 878: Biologicals 26:175-93.
65. World Health Organization. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. Technical Report Series 823:105-15.