More similar than different: Host cell protein production using three null CHO cell lines

Biotechnology and Bioengineering

Volumn 112, Issue 10, 2015, Pages 2068-2083

  Yuk, Inn H ^a   Nishihara, Julie ^a   Walker, Donald ^a   Huang, Eric ^a   Gunawan, Feny ^a   Subramanian, Jayashree ^a   Pynn, Abigail F J ^a   Yu, X Christopher ^a   Zhu Shimoni, Judith ^a   Vanderlaan, Martin ^a   Krawitz, Denise C ^a  

^a GENENTECH INC   (United States)

Author keywords

CHO host cell protein; ELISA; LC MS MS; Orthogonal methods; PLBL2; Proteomics

Indexed keywords

CELL CULTURE; CYTOLOGY; ELECTROPHORESIS; ENZYME ACTIVITY; FEEDSTOCKS; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULAR BIOLOGY; PROTEINS; RECOMBINANT PROTEINS;

ELISA; HOST CELL PROTEIN; LC-MS/MS; ORTHOGONAL METHOD; PLBL2; PROTEOMICS;

CELLS;

CELL PROTEIN; HOST CELL PROTEIN; LACTATE DEHYDROGENASE; LYSOPHOSPHOLIPASE; PHOSPHOLIPASE B LIKE 2; UNCLASSIFIED DRUG; PROTEOME;

ANIMAL CELL; ARTICLE; CELL DENSITY; CELL GROWTH; CELL LINEAGE; CHO CELL LINE; CYTOLYSIS; DOWNSTREAM PROCESSING; ENZYME LINKED IMMUNOSORBENT ASSAY; EXTRACELLULAR MATRIX; FED BATCH CULTURE; FEMALE; HOST CELL; IMMUNOGENICITY; MOLECULAR DYNAMICS; NONHUMAN; PRODUCTIVITY; PROTEIN ANALYSIS; PROTEIN SYNTHESIS; REVERSED PHASE LIQUID CHROMATOGRAPHY; TANDEM MASS SPECTROMETRY; TWO DIMENSIONAL GEL ELECTROPHORESIS; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; ANIMAL; CELL PROLIFERATION; CELL SURVIVAL; COMPARATIVE STUDY; CRICETULUS; LIQUID CHROMATOGRAPHY; TIME FACTOR;

CRICETULUS GRISEUS;

ANIMALS; CELL PROLIFERATION; CELL SURVIVAL; CHO CELLS; CHROMATOGRAPHY, LIQUID; CRICETULUS; ELECTROPHORESIS, GEL, TWO-DIMENSIONAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; L-LACTATE DEHYDROGENASE; LYSOPHOSPHOLIPASE; PROTEOME; TANDEM MASS SPECTROMETRY; TIME FACTORS;

EID: 84940467337     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.25615     Document Type: Article

References (50)

1. Bayzin-Hizal D, Tabb DL, Chaerkady R, Chen L, Lewis NE, Nagarajan H, Sarkaria V, Kumar A, Wolozny D, Colao J, Jacobson E, Tian Y, O'Meally RN, Krag SS, Cole RN, Palsson BO, Zhang H, Betenbaugh M. 2012. Proteomic analysis of Chinese hamster ovary cells. J Proteome Res 11:5265-5276.
2. Carlage T, Hincapie M, Zang L, Lyubarskaya Y, Madden H, Mhatre R, Hancock WS. 2009. Proteomic profiling of a high-producing Chinese hamster ovary cell culture. Anal Chem 81:7357-7362.
3. Champion KM, Nishihara JC, Joly JC, Arnott D. 2001. Similarity of the Escherichia coli proteome upon completion of different biopharmaceutical fermentation processes. Proteomics 1:1133-1148.
4. Chapra SC, Canale RP. 1988. Numerical methods for engineers, 2nd ed. New York: McGraw-Hill.
5. Chevalier F. 2010. Highlights on the capacities of "Gel-based" proteomics. Proteome Sci 8:23.
6. Doneau CE, Xenopoulos A, Fadgen K, Murphy J, Skilton SJ, Prentice H, Stapels M, Chen W. 2012. Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry. mAbs 4:24-44.
7. Godovac-Zimmermann J. Brown LR. 2001. Perspectives for mass spectrometry and functional proteomics. Mass Spectrom Rev 20:1-57.
8. Gramer MJ, Goochee CF. 1993. Glycosidase activities in Chinese hamster ovary cell lysate and cell culture supernatant. Biotechnol Prog 9:366-373.
9. Grzeskowiak JK, Tscheliessnig A, Toh PC, Chusainow J, Lee YY, Wong N, Jungbauer A. 2009. 2-D DIGE to expedite downstream process development for human monoclonal antibody purification. Protein Expr Purif 66:58-65.
10. Hossler P, Khattak SF, Li ZJ. 2009. Optimal and consistent glycosylation in mammalian cell culture. Glycobiology 19:936-949.
11. Hsu W-T., Aulakh RPS, Traul DL, Yuk IH. 2012. Advanced microscale bioreactor system: A representative scale-down model for bench-top bioreactors. Cytotechnology 64:667-678.
12. Hu Z, Guo D, Yip SSM, Zhan D, Misaghi S, Joly JC, Snedecor BR, Shen AY. 2013. Chinese hamster ovary (CHO) K1 host cell enables stable cell line development for antibody molecules which are difficult to express in DUXB11-derived dihydrofolate reductase (DHFR) deficient host cell. Biotechnol Prog 29:980-985.
13. Jensen AG, Chemali M, Chapel A, Kieffer-Jaquinod S, Jadot M, Garin J, Journet A. 2007. Biochemical characterization and lysosomal localization of the mannose-6-phosphate protein p76 (hypothetical protein LOC196463). Biochem J 402:449-458.
14. Jin M, Szapiel N, Zhang J, Hickey H, Ghose S. 2010. Profiling of host cell proteins by two-dimensional gel electrophoresis (2D-DIGE): Implications for downstream process development. Biotechnol Bioeng 105:306-316.
15. Kao F-T., Puck TT. 1968. Genetics of somatic mammalian cells, VII. Induction and isolation of nutritional mutants in Chinese hamster cells. Proc Natl Acad Sci USA 60:1275-1281.
16. Krawitz DC, Forrest W, Moreno GT, Kittleson J, Champion KM. 2006. Proteomic studies support the use of multi-product immunoassays to monitor host cell protein impurities. Proteomics 6:94-110.
17. Lakomek K, Dickmanns A, Kettwig M, Urlaub H, Ficner R, Lubke T. 2009. Initial insight into the function of the lysosomal 66.3kDa protein from mouse by means of X-ray crystallography. BMC Struct Biol 9:56.
18. Levy NE, Valente KN, Choe LH, Lee KH, Lenhoff AM. 2014. Identification and characterization of host cell protein product-associated impurities in monoclonal antibody bioprocessing. Biotechnol Bioeng 111:904-912.
19. Lewis NE, Liu X, Li Y, Nagarajan H, Yerganian G, O'Brien E, Bordbar A, Roth AM, Rosenbloom J, Bian C, Xie M, Chen W, Li N, Baycin-Hizal D, Latif H, Forster J, Betenbaugh MJ, Famili I, Xu X, Wang J, Palsson BO. 2013. Genomic landscapes of Chinese hamster ovary cell lines as revealed by the Cricetulus griseus draft genome. Nat Biotechnol 31:759-765.
20. McDonald P, Victa C, Carter-Franklin JN, Fahrner R. 2009. Selective antibody precipitation using polyelectrolytes: A novel approach to the purification of monoclonal antibodies. Biotechnol Bioeng 102:1141-1151.
21. Nishihara JC, Champion KM. 2002. Quantitative evaluation of proteins in one- and two-dimensional polyacrylamide gels using a fluorescent stain. Electrophoresis 23:2203-2215.
22. Omasa T, Higashiyama K, Shioya S, Suga K. 1992. Effects of lactate concentration on hybridoma culture in lactate-controlled fed-batch operation. Biotechnol Bioeng 39:556-564.
23. Pacis E, Yu M, Autsen J, Bayer R, Li F. 2011. Effects of cell culture conditions on antibody N-linked glycosylation-what affects high mannose 5 glycoform. Biotechnol Bioeng 108:2348-2358.
24. Petersen JF, McIntire LV, Papoutsakis ET. 1988. Shear sensitivity of cultured hybridoma cells (CRL-8018) depends on mode of growth, culture age and metabolite concentration. J Biotechnol 7:229-246.
25. Puck TT, Cieciura SJ, Robinson A. 1958. Genetics of somatic mammalian cells. III. Long-term cultivation of euploid cells from human and animal subjects. J Exp Med 108:945-956.
26. Rabilloud T, Chevallet M, Luche S, Lelong C. 2010. Two-dimensional gel electrophoresis in proteomics: Past, present, and future. J Proteomics 73:2064-2077.
27. Racher AJ, Looby D, Griffiths JB. 1990. Use of lactate dehydrogenase release to assess changes in culture viability. Cytotechnology 3:301-307.
28. Reisinger V, Toll H, Mayer RE, Visser J, Wolschin F. 2014. A mass spectrometry-based approach to host cell protein identification and its application in a comparability exercise. Anal Biochem 463:1-6.
29. Ryll T, Dutina G, Reyes A, Gunson J, Krummen L, Etcheverry T. 2000. Performance of small-scale CHO perfusion cultures using an acoustic cell filtration device for cell retention: Characterization of separation efficiency and impact of perfusion on product quality. Biotechnol Bioeng 69:440-449.
30. Schenauer MR, Flynn GC, Goetze AM. 2012. Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry. Anal Biochem 428:150-157.
31. Shukla AA, Jiang C, Ma J, Rubacha M, Flansburg L, Lee SS. 2008. Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes. Biotechnol Prog 24:615-622.
32. Singh SK. 2011. Impact of product-related factors on immunogenicity of biotherapeutics. J Pharm Sci 100:354-387.
33. Tait AS, Hogwood CEM, Smales CM, Bracewell DG. 2012. Host cell protein dynamics in the supernatant of a mAb producing CHO cell line. Biotechnol Bioeng 109:971-982.
34. Tscheliessnig AL, Konrath J, Bates R, Jungbauer A. 2013. Host cell protein analysis in therapeutic protein bioprocessing-methods and applications. Biotechnol J 8:655-670.
35. Urlaub G, Chasin LA. 1980. Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity. Proc Natl Acad Sci USA 77:4216-4220.
36. Valente KN, Schaefer AK, Kempton HR, Lenhoff AM, Lee KH. 2014. Recovery of Chinese hamster ovary host cell proteins for proteomic analysis. Biotechnol J 9:87-99.
37. Valente KN, Lenhoff AM, Lee KH. 2015. Expression of difficult-to-remove host cell protein impurities during extended Chinese hamster ovary cell culture and their impact on continuous bioprocessing. Biotechnol Bioeng 10.1002/bit.25515.
38. Vanderlaan M, Sandoval W, Liu P, Nishihara J, Tsui G, Lin M, Parker S, Wong RM, Low J, Wang X, Yang J, Veeravalli K, McKay P, O'Connell L, Tran B, Vij R, Fong C, Francissen F, Zhu-Shimoni J, Quarmby V, Krawitz D. 2015. Hamster Phospholipase B-like 2 (PLBL2), a host cell protein impurity in CHO-derived therapeutic monoclonal antibodies. BioProcess Int 13:18-29.
39. Wang X, Hunter AK, Mozier NM. 2009. Host cell proteins in biologics development: Identification, quantitation and risk assessment. Biotechnol Bioeng 103:446-458.
40. Yang M, Butler M. 2000. Enhanced erythropoietin heterogeneity in a CHO culture is caused by proteolytic degradation and can be eliminated by a high glutamine level. Cytotechnology 34:83-99.
41. Yu XC, Joe K, Zhang Y, Adriano A, Wang Y, Gazzano-Santoro H, Keck RG, Deperalta G, Ling V. 2011. Accurate determination of succinimide degradation products using high fidelity trypsin digestion peptide map analysis. Anal Chem 83:5912-5919.
42. Yuk IH, Zhang B, Yang Y, Dutina G, Leach KD, Vijayasankaran N, Shen AY, Andersen DC, Snedecor BR, Joly JC. 2011. Controlling glycation of recombinant antibody in fed-batch cell cultures. Biotechnol Bioeng 108:2600-2610.
43. Yuk IH, Russell S, Tang Y, Hsu W-T., Mauger JB, Aulakh RPS, Luo J, Gawlitzek M, Joly JC. 2015. Effects of copper on CHO cells: Cellular requirements and product quality considerations. Biotechnol Prog 31:226-238.
44. 2 or pH. Biotechnol Bioeng 65:182-191.
45. Zeid J, Harinarayan C, van Reis R. 2009. The impact of protein exclusion on the purity performance of ion exchange resins. Biotechnol Bioeng 102:971-976.
46. Zhang B, VerBerkmoes NC, Langston MA, Uberbacher E, Hettich RL, Samatova NF. 2006. Detecting differential and correlated protein expression in label-free shotgun proteomics. J Proteome Res 5:2909-2918.
47. Zhang Q, Goetze AM, Cui H, Wylie J, Trimble S, Hewig A, Flynn GC. 2014. Comprehensive tracking of host cell proteins during monoclonal antibody purifications using mass spectrometry. MAbs 6:659-670.
48. Zheng JY, Janis LJ. 2006. Influence of pH, buffer species, and storage temperature on physicochemical stability of a humanized monoclonal antibody LA298. Int J Pharm 308:46-51.
49. 2 and osmolality on growth of CHO cells and production of antibody-fusion protein B1: A case study. Biotechnol Prog 21:70-77.
50. Zhu-Shimoni J, Yu C, Nishihara J, Wong RM, Gunawan F, Lin M, Krawitz D, Liu P, Sandoval W, Vanderlaan M. 2014. Host cell protein testing by ELISAs and the use of orthogonal methods. Biotechnol Bioeng 111:2367-2379.