Assessment of the manufacturability of Escherichia coli high cell density fermentations

Biotechnology Progress

Volumn 27, Issue 5, 2011, Pages 1488-1496

  Perez Pardo, M A ^a   Ali, S ^a   Balasundaram, B ^a   Mannall, G J ^a   Baganz, F ^a   Bracewell, D G ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Bioprocess monitoring; Downstream processing; Fermentation; Fragment antibody; Scale down centrifugation

Indexed keywords

ANTIBODY FRAGMENT; BIOLOGICAL CONDITIONS; BIOPHARMACEUTICAL MANUFACTURE; BIOPROCESS MONITORING; CLARIFICATION PERFORMANCE; CRITICAL ATTRIBUTES; CULTIVATION TIME; DOWNSTREAM PROCESS; DOWNSTREAM UNITS; DOWNSTREAM-PROCESSING; FED-BATCH FERMENTATION; HIGH CELL DENSITY; HOST CELLS; MANUFACTURABILITY; MANUFACTURING CHALLENGES; MICRONIZATIONS; MODEL SYSTEM; PERIPLASM; PILOT SCALE; POTENTIAL LOSS; PROCESS UNDERSTANDING; PRODUCT RELEASE; QUALITY BY DESIGNS; SCALE-DOWN; ULTRA SCALE-DOWN; UPSTREAM PROCESS;

ANTIBODIES; CENTRIFUGATION; CENTRIFUGES; CLARIFIERS; DRUG PRODUCTS; ESCHERICHIA COLI; FERMENTATION; IMPACT STRENGTH; PARTICLE SIZE; PARTICLE SIZE ANALYSIS; PROCESSING; VISCOSITY;

CELLS;

ARTICLE; CENTRIFUGATION; CYTOLOGY; ESCHERICHIA COLI; FERMENTATION;

CENTRIFUGATION; ESCHERICHIA COLI; FERMENTATION;

ESCHERICHIA COLI;

EID: 80053922775     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.644     Document Type: Article

References (40)

1. Read EK, Part JT, Shah RB, Riley BS, Brorson KA, Rathore AS. Process analytical technology (PAT) for biopharmaceutical products: part I. Concepts and applications. Biotechnol Bioeng. 2009; 105: 276-284.
2. Rathore AS, Branning R, Cecchini D. Design space for Biotech products. BioPharm Int. 2007; 20: 36-40.
3. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009; 27: 26-34.
4. Mandenius CF, Graumann K, Schultz TW, Premstaller A, Olsson IM, Petiot E, Clemens C, Welin M. Quality-by-design for biotechnology-related pharmaceuticals. J Biotechnol. 2009; 4: 600-609.
5. GS Kee, Pujar NS, Titchener-Hooker NJ. Study of detergent-mediated liberation of Hepatitis B virus-like particles from S. cerevisiae homogenate: identifying a framework for the design of future-generation lipoprotein vaccine processes. Biotechnol Prog. 2008; 24: 623-631.
6. Bowering LC. Microbial systems for the manufacture of therapeutic antibody fragments. Bioprocess Intl. 2004; 2: 40-47.
7. Okamoto Y, Ohmori K, Glatz CE. Harvest time effects on membrane cake resistance of Escherichia coli broth. J Memb Sci. 2001; 190: 93-106.
8. Meireles M, Lavoute E, Bacchin P. Filtration of a bacterial fermentation broth: harvest conditions effects on cake hydraulic resistance. Bioprocess Biosystems Eng. 2003; 25: 309-314.
9. Wong HH, O'Neill BK, Middelberg APJ. Cumulative sedimentation analysis of Escherichia coli debris size. Biotechnol Bioeng. 1997; 55: 556-564.
10. Ropers D, De Jong H, Page M, Schneider D, Geiselmann J. Qualitative simulation of the carbon starvation response in Escherichia coli. Biosystems. 2006; 84: 124-152.
11. Tustian AD, Salte H, Willoughby N, Hassan I, Rose M, Baganz F, Hoare M, Titchener-Hooker NJ. Adapted ultra scale-down approach for predicting the centrifugal separation behaviour of high cell density cultures. Biotechnol Prog. 2007; 23: 1404-1410.
12. Humphreys DP, Vetterlein OM, Chapman AP, King DJ, Antoniw P, Suitters AJ, Reeks DG, Parton TA, King LM, Smith BJ, Lang V, Stephens PE. F(ab')2 molecules made from Escherichia coli produced Fab' with hinge sequences conferring increased serum survival in an animal model. J Immunol Methods. 1998; 217: 1-10.
13. Bowering LC, Bracewell DG, Keshavarz-Moore E, Hoare M, Weir ANC. Comparison of techniques for monitoring antibody fragment production in E. coli fermentation cultures. Biotechnol Prog. 2002; 18: 1431-1438.
14. Garcia-Arrazola R, Dawson P, Buchanan I, Doyle B, Fearn T, Titchener-Hooker NJ, Baganz F. Evaluation of the effects and interactions of mixing and oxygen transfer on the production of Fab' antibody fragments in Escherichia coli fermentation with gas blending. Bioprocess Biosyst Eng. 2005; 27: 365-374.
15. Horn U, Strittmatter W, Krebber A, Knupfer U, Kujau M, Wenderoth R, Muller K, Matzku S, Pluckthun A, Riesenberg D. High volumetric yields of functional dimeric mini-antibodies in Escherichia coli, using an optimized expression vector and high-cell-density fermentation under non-limited growth conditions. Appl Microbiol Biotechnol. 1996; 46: 524-532.
16. Boychyn M, Yim SSS, Ayazi Shamlou P, Bulmer M, More J, Hoare M. Characterisation of flow intensity in continuous centrifuges for the development of laboratory mimics. Chem Eng Sci. 2001; 56: 4758-4770.
17. Maybury JP, Hoare M, Dunnill P. The use of laboratory centrifugation studies to predict performance of industrial machines: studies of shear insensitive and shear sensitive materials. Biotechnol Bioeng. 2000; 67: 265-273.
18. Levy MS, Ciccolini LAS, Yim SSS, Tsai JT, Titchener-Hooker N, Ayazi Shamlou P, Dunnill P. The effects of material properties and fluid flow intensity on plasmid DNA recovery during cell lysis. Chem Eng Sci. 1999; 54: 3171-3178.
19. Hutchinson N, Bingham N, Murrell N, Farid S, Hoare M. Shear stress analysis of mammalian cell suspensions for prediction of industrial centrifugation and its verification. Biotechnol Bioeng. 2006; 95: 483-491.
20. Tait AS, Aucamp JP, Bugeon A, Hoare M. Ultra scale down prediction using microwell technology of the industrial scale clarification characteristics by centrifugation of mammalian cell broths. Biotechnol Bioeng. 2009; 104: 321-331.
21. Wenger MD, DePhillips P, Bracewell DG. A microscale yeast cell disruption technique for integrated process development strategies. Biotechnol Prog. 2008; 24: 606-614.
22. Tustian AD. An engineering study of key interactions within the process for antibody fragment production. Ph.D. Thesis, University College London; 2008: pp. 89.
23. Pinheiro H, Cabral JMS. Centrifugation. In: Kennedy JF, Cabral JMS, editor. Recovery Processes for Biological Materials. Chichester: John Wiley & Sons; 1993: 145.
24. Hetherington PJ, Follows M, Dunnill P, Lilly MD. Release of protein from bakers' yeast (Saccharomyces cerevisiae) by disruption in an industrial homogeniser. Trans Inst Chem Eng. 1971; 49: 142-148.
25. Harrison ST, Dennis JS, Chase HA. The effect of culture history on the disruption of Alcaligenes eutrophus by high pressure homogenisation. In: Separations for Biotechnology, 2nd ed.; Pyle, ED., Elsevier Applied Science: London and New York, 1990: 38-47.
26. Zhang Y, Taiming L, Liu J. Low temperature and glucose enhanced T7 RNA polymerase-based plasmid stability for increasing expression of glucagons-like peptide-2 in Escherichia coli. Protein Expr Purif. 2003; 29: 132-139.
27. Moore JD, Perez-Pardo MA, Popplewell JF, Spencer SJ, Ray S, Swann MJ, Shard AG, Jones W, Hills A, Bracewell DG. Chemical and biological characterisation of a sensor surface for bioprocess monitoring. Biosens Bioelectron. 2011; 26: 2940-2947.
28. Laugharn JA, Garrison BS. Apparatus and method for controlling sonic treatment. U.S. Patent 6, 719, 449 B1; 2004.
29. Davies R. Observations on the use of ultrasound waves for the disruption of micro-organisms. Biochim Biophys Acta. 1959; 33: 481-493.
30. Kula MR, Schutte H. Purification of proteins and the disruption of microbial cells. Biotech Prog. 1987; 3: 31-42.
31. Want A, Thomas ORT, Kara B, Liddell J, Hewitt CJ. Studies related to antibody fragment (Fab') production in Escherichia coli W3110 fed batch fermentation processes using multiparameter flow cytometry. Cytometry A. 2009; 75: 148-154.
32. Titchener NJ, Dunnill P, Hoare M. Micro biochemical engineering to accelerate the design of industrial-scale downstream processes for biopharmaceutical processes. Biotech Bioeng. 2008; 100: 473-487.
33. Lewis G, Taylor IW, Nienow AW, Hewitt CJ. The application of multi-parameter flow cytometry to the study of recombinant Escherichia coli batch fermentation processes. J Ind Microbiol Biotechnol. 2004; 31: 311-322.
34. Chen RR. Permeability issues in whole cell bioprocesses and cellular membrane engineering. Appl Microbiol Biotechnol. 2007; 74: 730-738.
35. Bayer ME. Response of cell walls of Escherichia coli to a sudden reduction of the environmental osmotic pressure. J Bacteriol. 1967; 93: 1104-1112.
36. Balasundaram B, Nesbeth D, Ward JM, Keshavarz-Moore E, Bracewell DG. Step change in the efficiency of centrifugation through cell engineering: co-expression of Staphylococcal nuclease to reduce the viscosity of the bioprocess feedstock. Biotechnol Bioeng. 2009; 104: 134-142.
37. Shokri A, Larsson G. Characterisation of the Escherichia coli membrane structure and function during fedbatch cultivation. Microbiol Cell Fact. 2004; 3: 9-21.
38. Alexander CL, Shamlou PA, Breen LH, Mostafa SS. Development of a robust process for harvesting bioreactors. AIChE Meeting, San Francisco, CA, 2006; Abstract 457 d.
39. Iammarino M, Nti-Gyabaah J, Chandler M, Roush D, Goklen K. Impact of cell density and viability on primary clarification of mammalian cell broth. Bioprocess Int. 2007; 5: 39-50.
40. Staby A, Johansen N, Wahlstrøm H, Mollerup I. Comparison of loading capacities of various proteins and peptides in culture medium and in pure state. J Chromatogr A. 1998; 827: 311-318.