The business impact of an integrated continuous biomanufacturing platform for recombinant protein production

Journal of Biotechnology

Volumn 213, Issue , 2015, Pages 3-12

  Walther, Jason ^a   Godawat, Rahul ^a   Hwang, Chris ^a   Abe, Yuki ^b   Sinclair, Andrew ^b   Konstantinov, Konstantin ^a  

^a SANOFI   (France)

^b BioPharm Services UK   (United Kingdom)

Author keywords

Biosolve; Continuous bioprocessing; Continuous capture; Cost of goods; Net present value; Perfusion cell culture

Indexed keywords

BATCH DATA PROCESSING; CELL CULTURE; INTELLIGENT SYSTEMS; MONTE CARLO METHODS; PROTEINS; RECOMBINANT PROTEINS;

BIOSOLVE; CONTINUOUS BIOPROCESSING; CONTINUOUS CAPTURES; COST-OF-GOODS; NET PRESENT VALUE; PERFUSION CELL CULTURES;

CONTINUOUS CELL CULTURE;

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ARTICLE; BATCH PROCESS; BIOREACTOR; BIOTECHNOLOGICAL PRODUCTION; CAPITAL; COMMERCIAL PHENOMENA; CONTINUOUS PROCESS; CONTROLLED STUDY; COST; COST CONTROL; FED BATCH REACTOR; INTEGRATED CONTINUOUS BIOMANUFACTURING; INTERMETHOD COMPARISON; MICROCARRIER PERFUSION REACTOR; MONTE CARLO METHOD; PRIORITY JOURNAL; PROCESS TECHNOLOGY; PROTEIN SYNTHESIS; REACTOR OPERATION; SUSPENDED PERFUSION REACTOR; BIOTECHNOLOGY; DRUG INDUSTRY; ECONOMICS; RISK; THEORETICAL MODEL;

BIOREACTORS; BIOTECHNOLOGY; COMMERCE; DRUG INDUSTRY; MODELS, THEORETICAL; MONTE CARLO METHOD; RECOMBINANT PROTEINS; RISK;

EID: 84942824422     PISSN: 01681656     EISSN: 18734863     Source Type: Journal    
DOI: 10.1016/j.jbiotec.2015.05.010     Document Type: Article

References (36)

1. Tanner A.H. Continuous Casting: A revolution in Steel 1998, Write Stuff Syndicate, Fort Lauderdale, FL.
2. Pattison R.N., Swamy J., Mendenhall B., Hwang C., Frohlich B.T. Measurement and control of dissolved carbon dioxide in mammalian cell culture processes using an in situ fiber optic chemical sensor. Biotechnol. Prog. 2000, 16:769-774. 10.1021/bp000089c.
3. Anderson N.G. Practical use of continuous processing in developing and scaling up laboratory processes. Org. Process Res. Dev. 2001, 5:613-621. 10.1021/op0100605.
4. Sinclair A., Monge M. Quantitative economic evaluation of single use disposables in bioprocessing. Pharm. Eng. 2002, 22(3):20-34.
5. Rathore A.S., Levine H., Curling J., Kaltenbrunner O., Latham P. Costing issues in the production of biopharmaceuticals. BioPharm Int. 2004, 17(2):46-55.
6. Werner R.G. Economic aspects of commercial manufacture of biopharmaceuticals. J. Biotechnol. 2004, 113:171-182. 10.1016/j.jbiotec.2004.04.036.
7. Rajapakse A., Titchener-Hooker N.J., Farid S.S. Modelling of the biopharmaceutical drug development pathway and portfolio management. Comput. Chem. Eng. 2005, 29:1357-1368. 10.1016/j.compchemeng.2005.02.010.
8. Farid S.S. Process economics of industrial monoclonal antibody manufacture. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2007, 10.1016/j.jchromb.2006.07.037.
9. Kelley B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol. Prog. 2007, 10.1021/bp070117s.
10. Sinclair A., Lim J. Process economy of disposable manufacturing-process models to minimize upfront investment. Am. Pharm. Rev. 2007, 10(6):114.
11. Croughan M. The silver anniversary of clinical protein production from recombinant CHO cells. In ITQB Seminar 2008.
12. Thomas H. Batch-to-continuous-coming out of age. Chem. Eng. 2008, 805:38-40.
13. Kelley B. Industrialization of mAb production technology: The bioprocessing industry at a crossroads. mAbs 2009, 10.4161/mabs.1.5.9448.
14. Eibl R., Kaiser S., Lombriser R., Eibl, D Disposable bioreactors: The current state-of-the-art and recommended applications in biotechnology. Appl. Microbiol. Biotechnol. 2010, 10.1007/s00253-009-2422-9.
15. Han C., Nelson P., Tsai A. Process development's impact on cost of goods manufactured (COGM). BioProcess Int. 2010, 8(3):48-55.
16. Shukla A.A., Thömmes J. Recent advances in large-scale production of monoclonal antibodies and related proteins. Trend Biotechnol. 2010, 10.1016/j.tibtech.2010.02.001.
17. Godawat R., Brower K., Jain S., Konstantinov K., Riske F., Warikoo V. Periodic counter-current chromatography-design and operational considerations for integrated and continuous purification of proteins. Biotechnol. J. 2012, 7:1496-1508. 10.1002/biot.201200068.
18. Warikoo V., Godawat R., Brower K., Jain S., Cummings D., Simons E., Konstantinov K. Integrated continuous production of recombinant therapeutic proteins. Biotechnol. Bioeng. 2012, 109:3018-3029. 10.1002/bit.24584.
19. Baker J. Matching flows: the development of continuous bioprocessing, new initiatives in the approval of bioproducts, and assurance of product quality throughout the product lifecycle. In Integrated Continuous Biomanufacturing 2013.
20. Farid S.S. Cost-effectiveness and robustness evaluation for biomanufacturing. BioProcess Int. 2013, 11(11):20-27.
21. Gottschalk U., Brorson K., Shukla A.A. Innovation in biomanufacturing: the only way forward. Pharm. Bioprocess. 2013, 1(2):141-157.
22. Levine H., Stock R., Lilja J., Gaasvik A., Hummel H., Ransofoff T.C., Dana Jones S. Single-use technology and modular construction. BioProcess Int. 2013, 11:40-45.
23. Love J.C., Love K.R., Barone P.W. Enabling global access to high-quality biopharmaceuticals. Curr. Opin. Chem. Eng. 2013, 10.1016/j.coche.2013.09.002.
24. Pollock J., Bolton G., Coffman J., Ho S.V., Bracewell D.G., Farid S.S. Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture. J. Chromgr. A 2013, 1284:17-27. 10.1016/j.chroma.2013.01.082.
25. Pollock J., Ho S.V., Farid S.S. Fed-batch and perfusion culture processes: Economic, environmental, and operational feasibility under uncertainty. Biotechnol. Bioeng. 2012, 110:206-219. 10.1002/bit.24608.
26. Reay D., Ramshaw C., Harvey A. Process intensification. Process Intensif. 2013, 27-55. 10.1016/B978-0-08-098304-2.00002-X.
27. Shukla A.A., Gottschalk U. Single-use disposable technologies for biopharmaceutical manufacturing. Trends Biotechnol. 2013, 10.1016/j.tibtech.2012.10.004.
28. Weintraub, K., (2013). Biotech firms in race for manufacturing breakthrough. MIT Technology Review. January.
29. Whitford, W. G., and Sargent, B.(2013). Continuous processing: from cookie preparation to cell-based production. Cell Culture Dish. March.
30. Aggarwal S.R. What's fueling the biotech engine - 2012 to 2013. Nat. Biotechnol. 2014, 32(1):32-39.
31. Biopharm Services, 2014. Mab manufacturing today and tomorrow. Retrieved from . http://biopharmservices.com/project/whitepaper-mab-manufacturing-today-and-tomorrow/.
32. EDB Singapore, 2014. Amgen Opens Next-Generation Biomanufacturing Facility in Singapore.
33. Ernst and Young., 2014. Biotechnology Industry Report.
34. Gronemeyer P., Ditz R., Strube J. Trends in upstream and downstream process development for antibody manufacturing. Bioengineering 2014, 1(4):188-212.
35. Hay M., Thomas D.W., Craighead J.L., Economides C., Rosenthal J. Clinical development success rates for investigational drugs. Nat. Biotechnol. 2014, 32:40-51. 10.1038/nbt.2786.
36. Konstantinov K.B., Cooney C.L. Continuous Bioprocessing. In International Symposium on Continuous Manufacturing of Pharmaceuticals (p. White Paper 4) 2014, Retrieved from http://iscmp.mit.edu/white-papers/white-paper-4.