The need for innovation in biomanufacturing

Nature Biotechnology

Volumn 30, Issue 6, 2012, Pages 489-492

  Gottschalk, Uwe ^a   Brorson, Kurt ^b   Shukla, Abhinav A ^c  

^a SARTORIUS STEDIM BIOTECH GMBH   (Germany)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c KBI Biopharma   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CELL PROTEIN;

BIOREACTOR DESIGN; BIOTECHNOLOGY; CHROMATOGRAPHY; FED BATCH CULTURE; HOST CELL; LETTER; NANOTECHNOLOGY; NONHUMAN; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; PRODUCTIVITY; QUALITY CONTROL;

ANIMALS; BIOENGINEERING; BIOREACTORS; BIOTECHNOLOGY; CELL CULTURE TECHNIQUES; CELL LINE; CHROMATOGRAPHY; CULTURE MEDIA; HUMANS; VIRUS CULTIVATION;

EID: 84862008938     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2263     Document Type: Letter

References (23)

1. Wurm, F. Nat. Biotechnol. 22, 1393-1398 (2004).
2. Cost, G. et al. Biotechnol. Bioeng. 105, 330-340 (2010).
3. Lute, S., Bailey, M., Combs, J., Sukumar, M. & Brorson, K. Biotechnol. Appl. Biochem. 47, 141-151 (2007).
4. Brown, A. et al. Biotechnol. Bioeng. 106, 627-637 (2010).
5. Parenteral Drug Association (PDA). Virus Filtration. Technical Report No 41. PDA J. Pharm. Sci. Technol. 62, S-4 (2008).
6. Gottschalk, U. Biotechnol. Prog. 24, 496-503 (2008).
7. Pujar, N., Low, D. & O'Leary, R. Antibody purification: drivers of change. in Process Scale Purification of Antibodies (ed. Gottschalk, U.) 407-426 (John Wiley & Sons, NY, 2009).
8. Kelley, B. Biotechnol. Prog. 23, 995-1008 (2007).
9. Thommes, J. & Etzel, M. Biotechnol. Prog. 23, 42-45 (2007).
10. Wang, J., Diehl, T., Aguiar, D., Xiao-Ping, D. & Arunakumari, A. BioPharm Int. 23, 4-14 (2009).
11. Grage, K. & Rehm, B.H.A. Bioconjug. Chem. 19, 254-262 (2008).
12. Zhou, J. & Tressel, T. Biotechnol. Prog. 22, 341-349 (2006).
13. Faber, R., Yang, Y. & Gottschalk, U. BioPharm Int. 23, 11-14 (2009).
14. International Conference on Harmonization (ICH). Q11: Development and Manufacture of Drug Substances, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, Geneva, Switzerland, 2011).
15. Rathore, A.S. & Winkle, H. Nat. Biotechnol. 27, 26-34 (2009).
16. CMC Biotech Working Group. A-Mab: a Case Study in Bioprocess Development. Version 2.1 (CMC2009)
17. Jiang, C., Flansburg, L., Ghose, S., Jorjorian, P. & Shukla, A. Biotechnol. Bioeng. 107, 989-1001 (2010).
18. Lutz, H. et al. Biotechnol. Prog. 27, 121-128 (2011).
19. Parenteral Drug Association (PDA). Preparation of Virus Spikes Used for Virus Clearance Studies. Technical Report No. 47. (PDA, Bethesda, MD, 2010).
20. Carter-Franklin, J.N., Victa, C., McDonald, P. & Fahrner, R. J. Chromatogr. A 1163, 105-111 (2007).
21. Jin, M., Szapiel, N., Zhang, J., Hickey, J. & Ghose, S. Biotechnol. Bioeng. 105, 306-316 (2010).
22. Stettler, M., Zhank, X., Hacker, D.L., de Jesus, M. & Wurm, F. Biotechnol. Prog. 23, 1340-1346 (2007).
23. Rajendra, S., Kiseljack, D., Baldi, L., Hacker, D. & Wurm, F.J. Biotechnol. 153, 22-26 (2011).