Online prediction of product titer and solubility of recombinant proteins in Escherichia coli fed-batch cultivations

Journal of Chemical Technology and Biotechnology

Volumn 90, Issue 2, 2015, Pages 283-290

  Luchner, Markus ^a,b   Striedner, Gerald ^a,b   Cserjan Puschmann, Monika ^a,b   Strobl, Florian ^a   Bayer, Karl ^b  

^a AUSTRIAN CENTRE OF INDUSTRIAL BIOTECHNOLOGY   (Austria)

^b UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES   (Austria)

Author keywords

Advanced bioprocess monitoring; E. coli fermentation process; QbD; Recombinant protein production; Statistical modeling

Indexed keywords

COMPLEX NETWORKS; DATA FLOW ANALYSIS; DESIGN; ESCHERICHIA COLI; FERMENTATION; FLUORESCENCE; FORECASTING; INTELLIGENT CONTROL; KNOWLEDGE BASED SYSTEMS; LEAST SQUARES APPROXIMATIONS; NEURAL NETWORKS; PROCESS CONTROL; PROCESS MONITORING; PROTEINS; RADIAL BASIS FUNCTION NETWORKS; RECOMBINANT PROTEINS; SOCIAL NETWORKING (ONLINE); SOLUBILITY; STATISTICAL METHODS;

BIOPROCESS MONITORING; E. COLI FERMENTATION PROCESS; QBD; RECOMBINANT PROTEIN PRODUCTIONS; STATISTICAL MODELING;

QUALITY CONTROL;

RECOMBINANT PROTEIN;

ACCURACY; ARTICLE; ARTIFICIAL NEURAL NETWORK; BIOPROCESS; CONTROLLED STUDY; ESCHERICHIA COLI; FED BATCH FERMENTATION; FLUORESCENCE; GENE DOSAGE; GENE EXPRESSION SYSTEM; NONHUMAN; ONLINE MONITORING; PARTIAL LEAST SQUARES REGRESSION; PREDICTION; PROCESS CONTROL; PROCESS MONITORING; PROTEIN TARGETING; QUALITY CONTROL; SOLUBILITY;

ESCHERICHIA COLI;

EID: 84920914659     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.4463     Document Type: Article

References (46)

1. FDA US, Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, ed by Fda US. U.S. Food and Drug Administration, Rockville, MD (2004).
2. Read EK, Park JT, Shah RB, Riley BS, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications. Biotechnol Bioeng 105:276-284 (2010).
3. Read EK, Shah RB, Riley BS, Park JT, Brorson KA and Rathore AS, Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications. Biotechnol Bioeng 105:285-295 (2010).
4. Food and Drug Administration HHS, International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice. Fed Regist 74: 15990-15991 (2009).
5. Food and Drug Administration HHS, International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice. Fed Regist 74: 27325-27326 (2009).
6. Mandenius CF, Graumann K, Schultz TW, Premstaller A, Olsson IM, Petiot E, Clemens C and Welin M, Quality-by-design for biotechnology-related pharmaceuticals. Biotechnol J 4:600-609 (2009).
7. Rathore AS, Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol 27:546-553 (2009).
8. Rathore A, Technology Drivers for Quality by Design (QbD) Implementation for Biopharmaceutical Products. PDA J Pharm Sci Technol 65:345 (2011).
9. Yu LX, Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 25:781-791 (2008).
10. Lopes JA, Costa PF, Alves TP and Menezes JC, Chemometrics in bioprocess engineering: process analytical technology (PAT) applications. Chemometrics Intell Lab Syst 74:269-275 (2004).
11. Pomerantsev AL and Rodionova OY, Process analytical technology: a critical view of the chemometricians. J Chemometrics 26:299-310 (2012).
12. Varmuza K and Filzmoser P, Introduction to Multivariate Statistical Analysis in Chemometrics, Taylor & Francis, Boca Raton (2008).
13. Glassey J, Gernaey KV, Clemens C, Schulz TW, Oliveira R, Striedner G and Mandenius CF, Process analytical technology (PAT) for biopharmaceuticals. Biotechnol J 6:369-377 (2011).
14. Luttmann R, Bracewell DG, Cornelissen G, Gernaey KV, Glassey J, Hass VC, Kaiser C, Preusse C, Striedner G and Mandenius CF, Soft sensors in bioprocessing: a status report and recommendations. Biotechnol J 7:1040-1048 (2012).
15. Sonnleitner B, Instrumentation of Biotechnological Processes, in Bioanalysis and Biosensors for Bioprocess Monitoring, ed by Sonnleitner B. Springer, Berlin Heidelberg, p. 1-64 (2000).
16. Vojinović V, Cabral JMS and Fonseca LP, Real-time bioprocess monitoring: Part I: In situ sensors. Sensors Actuators B: Chem 114:1083-1091 (2006).
17. Vojislav V, J.M.S. C and L.R. F, Ex situ bioprocess monitoring techniques. Chem Ind Chem Eng Q 13:103-116 (2007).
18. Luchner M, Gutmann R, Bayer K, Dunkl J, Hansel A, Herbig J, Singer W, Strobl F, Winkler K and Striedner G, Implementation of proton transfer reaction-mass spectrometry (PTR-MS) for advanced bioprocess monitoring. Biotechnol Bioeng 109:3059-3069 (2012).
19. Clementschitsch F, Kern J, Pötschacher F and Bayer K, Sensor combination and chemometric modelling for improved process monitoring in recombinant E. coli fed-batch cultivations. J Biotechnol 120:183-196 (2005).
20. Striedner G and Bayer K, An advanced monitoring platform for rational design of recombinant processes. Adv Biochem Eng Biotechnol 132:65-84 (2013).
21. Schumann W and Ferreira LCS, Production of recombinant proteins in Escherichia coli. Genet Mol Biol 27:442-453 (2004).
22. Terpe K, Overview of bacterial expression systems for heterologous protein production: from molecular and biochemical fundamentals to commercial systems. Appl Microbiol Biotechnol 72:211-222 (2006).
23. Graumann K and Premstaller A, Manufacturing of recombinant therapeutic proteins in microbial systems. Biotechnol J 1:164-186 (2006).
24. Rinas U and Bailey JE, Protein compositional analysis of inclusion bodies produced in recombinant Escherichia coli. Appl Microbiol Biotechnol 37:609-614 (1992).
25. Wållberg F, Sundström H, Ledung E, Hewitt CJ and Enfors SO, Monitoring and quantification of inclusion body formation in Escherichia coli by multi-parameter flow cytometry. Biotechnol Lett 27:919-926 (2005).
26. Margreiter G, Schwanninger M, Bayer K and Obinger C, Impact of different cultivation and induction regimes on the structure of cytosolic inclusion bodies of TEM1-beta-lactamase. Biotechnol J 3:1245-1255 (2008).
27. Schlieker C, Bukau B and Mogk A, Prevention and reversion of protein aggregation by molecular chaperones in the E. coli cytosol: implications for their applicability in biotechnology. J Biotechnol 96:13-21 (2002).
28. Jungbauer A and Kaar W, Current status of technical protein refolding. J Biotechnol 128:587-596 (2007).
29. Lilie H, Schwarz E and Rudolph R, Advances in refolding of proteins produced in E. coli. Current Opin Biotechnol 9:497-501 (1998).
30. Gatti-Lafranconi P, Natalello A, Ami D, Doglia SM and Lotti M, Concepts and tools to exploit the potential of bacterial inclusion bodies in protein science and biotechnology. FEBS J 278:2408-2418 (2011).
31. Achmüller C, Kaar W, Ahrer K, Wechner P, Hahn R, Werther F, Schmidinger H, Cserjan-Puschmann M, Clementschitsch F, Striedner G, Bayer K, Jungbauer A and Auer B, N(pro) fusion technology to produce proteins with authentic N termini in E. coli. Nat Methods 4:1037-1043 (2007).
32. Striedner G, Cserjan-Puschmann M, Pötschacher F and K B, Tuning the transcription rate of recombinant protein in strong Escherichia coli expression systems through repressor titration. Biotechnol Prog 19:1427-1432 (2003).
33. Grabherr R and Bayer K, Impact of targeted vector design on Co/E1 plasmid replication. Trends Biotechnol 20:257-260 (2002).
34. Diaz Ricci JC and Hernández ME, Plasmid effects on Escherichia coli metabolism. Crit Rev Biotechnol 20:79-108 (2000).
35. Lin-Chao S and Bremer H, Effect of the bacterial growth rate on replication control of plasmid pBR322 in Escherichia coli. Mol Gen Genet 203:143-149 (1986).
36. Popov M, Petrov S, Nacheva G, Ivanov I and Reichl U, Effects of a recombinant gene expression on ColE1-like plasmid segregation in Escherichia coli. BMC Biotechnol 11:18 (2011).
37. Grabherr R, Nilsson E, Striedner G and Bayer K, Stabilizing plasmid copy number to improve recombinant protein production. Biotechnol Bioeng 77:142-147 (2002).
38. We'grzyn G and We'grzyn A, Is tRNA only a translation factor or also a regulator of other processes? J Appl Genet 49:115-122 (2008).
39. Studier FW, Rosenberg AH, Dunn JJ and Dubendorff JW, Use of T7 RNA polymerase to direct expression of cloned genes. Methods Enzymol 185:60-89 (1990).
40. Studier FW, Use of bacteriophage T7 lysozyme to improve an inducible T7 expression system. J Mol Biol 219:37-44 (1991).
41. Marisch K, Bayer K, Cserjan-Puschmann M, Luchner M and Striedner G, Evaluation of three industrial Escherichia coli strains in fed-batch cultivations during high-level SOD protein production. Microb Cell Fact 12:58 (2013).
42. Cserjan-Puschmann M, Kramer W, Duerrschmid E, Striedner G and Bayer K, Metabolic approaches for the optimisation of recombinant fermentation processes. Appl Microbiol Biotechnol 53:43-50 (1999).
43. Porstmann T, Wietschke R, Schmechta H, Grunow R, Porstmann B, Bleiber R, Pergande M, Stachat S and von Baehr R, A rapid and sensitive enzyme immunoassay for Cu/Zn superoxide dismutase with polyclonal and monoclonal antibodies. Clin Chim Acta 171:1-10 (1988).
44. Striedner G, Pfaffenzeller I, Markus L, Nemecek S, Grabherr R and Bayer K, Plasmid-free T7-based Escherichia coli expression systems. Biotechnol Bioeng 105:786-794 (2010).
45. Savitzky A and Golay MJE, Smoothing and differentiation of data by simplified least squares procedures. Anal Chem 36:1627-1639 (1964).
46. Kastberger G and Kranner G, Visualization of multiple influences on ocellar flight control in giant honeybees with the data-mining tool Viscovery SOMine. Behav Res Methods, Instru Comput 32:157-168 (2000).