Bioreactor process parameter screening utilizing a plackett-burman design for a model monoclonal antibody

Journal of Pharmaceutical Sciences

Volumn 104, Issue 6, 2015, Pages 1919-1928

  Agarabi, Cyrus D ^a   Schiel, John E ^b   Lute, Scott C ^a   Chavez, Brittany K ^a   Boyne, Michael T ^a   Brorson, Kurt A ^a   Khan, Mansoor A ^a   Read, Erik K ^a  

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

^b NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY   (United States)

Author keywords

biotechnology; cell culture; design of experiments (DoE); glycan profiling; glycoprotein; glycosylation; mass spectrometry; monoclonal antibody; Plackett Burman; quality by design (QbD)

Indexed keywords

FATTY ACID; GLYCAN; HYDROCORTISONE; MONOCLONAL ANTIBODY; NONESSENTIAL AMINO ACID; IMMUNOGLOBULIN G; POLYSACCHARIDE;

AGITATION; ANIMAL CELL; ARTICLE; BIOREACTOR PROCESS PARAMETER; CELL CULTURE; EXERCISE; EXPERIMENTAL DESIGN; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; FUCOSYLATION; HYBRIDOMA CELL CULTURE; INOCULATION; NONHUMAN; PARAMETERS; PH; PLACKETT BURMAN DESIGN; PROCESS OPTIMIZATION; SIALYLATION; TEMPERATURE; VALIDATION STUDY; ANIMAL; BIOREACTOR; CARBOHYDRATE ANALYSIS; CELL PROLIFERATION; CHEMISTRY; CULTURE TECHNIQUE; CYTOLOGY; GLYCOSYLATION; HYBRIDOMA; MASS SPECTROMETRY; METABOLISM; MOLECULAR GENETICS; MOUSE; PROCEDURES;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOREACTORS; CARBOHYDRATE SEQUENCE; CELL CULTURE TECHNIQUES; CELL PROLIFERATION; GLYCOSYLATION; HYBRIDOMAS; IMMUNOGLOBULIN G; MASS SPECTROMETRY; MICE; MOLECULAR SEQUENCE DATA; POLYSACCHARIDES; TEMPERATURE;

EID: 84929160974     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24420     Document Type: Article

References (49)

1. Chen ZL, Wu BC, Liu H, Huang PT,. 2004. Temperature shift as a process optimization step for the production of pro-urokinase by a recombinant Chinese hamster ovary cell line in high-density perfusion culture. J Biosci Bioeng 97 (4): 239-243.
2. Ogawa T, Kamihira M, Yoshida H, Iijima S, Kobayashi T,. 1992. Effect of dissolved-oxygen concentration on monoclonal-antibody production in hybridoma cell-cultures. J Ferment Bioeng 74 (6): 372-378.
3. Trummer E, Fauland K, Seidinger S, Schriebl K, Lattenmayer C, Kunert R, Vorauer-Uhl K, Weik R, Borth N, Katinger H, Muller D,. 2006. Process parameter shifting: Part I. Effect of DOT, pH, and temperature on the performance of Epo-Fc expressing CHO cells cultivated in controlled batch bioreactors. Biotechnol Bioeng 94 (6): 1033-1044.
4. Abu-Reesh I, Kargi F,. 1991. Biological responses of hybridoma cells to hydrodynamic shear in an agitated bioreactor. Enzyme Microb Technol 13 (11): 913-919.
5. Lu F, Toh PC, Burnett I, Li F, Hudson T, Amanullah A, Li JC,. 2013. Automated dynamic fed-batch process and media optimization for high productivity cell culture process development. Biotechnol Bioeng 110 (1): 191-205.
6. Read EK, Bradley SA, Smitka TA, Agarabi CD, Lute SC, Brorson KA,. 2013. Fermentanomics informed amino acid supplementation of an antibody producing mammalian cell culture. Biotechnol Prog 29 (3): 745-753.
7. Rouiller Y, Perilleux A, Marsaut M, Stettler M, Vesin MN, Broly H,. 2012. Effect of hydrocortisone on the production and glycosylation of an Fc-fusion protein in CHO cell cultures. Biotechnol Prog 28 (3): 803-813.
8. Madhavarao CN, Agarabi CD, Wong L, Muller-Loennies S, Braulke T, Khan M, Anderson H, Johnson GR,. 2014. Evaluation of butyrate-induced production of a mannose-6-phosphorylated therapeutic enzyme using parallel bioreactors. Biotechnol Appl Biochem 61 (2): 184-192.
9. Banerjee A, Ma NN, Ramasubramanyan N,. 2010. Designing in quality: Approaches to defining the design space for a monoclonal antibody process. Biopharm Int 23 (5): 26-40.
10. Chee Furng Wong D, Tin Kam Wong K, Tang Goh L, Kiat Heng C, Gek Sim Yap M,. 2005. Impact of dynamic online fed-batch strategies on metabolism, productivity and N-glycosylation quality in CHO cell cultures. Biotechnol Bioeng 89 (2): 164-177.
11. Hasegawa H, Wendling J, He F, Trilisky E, Stevenson R, Franey H, Kinderman F, Li G, Piedmonte DM, Osslund T, Shen M, Ketchem RR,. 2011. In vivo crystallization of human IgG in the endoplasmic reticulum of engineered Chinese hamster ovary (CHO) cells. J Biol Chem 286 (22): 19917-19931.
12. Hmiel LK, Brorson KA, Boyne MT 2nd,. 2015. Post-translational structural modifications of immunoglobulin G and their effect on biological activity. Anal Bioanal Chem 407 (1): 79-94.
13. Suzuki E, Niwa R, Saji S, Muta M, Hirose M, Iida S, Shiotsu Y, Satoh M, Shitara K, Kondo M, Toi M,. 2007. A nonfucosylated anti-HER2 antibody augments antibody-dependent cellular cytotoxicity in breast cancer patients. Clin Cancer Res 13 (6): 1875-1882.
14. Matsumiya S, Yamaguchi Y, Saito J, Nagano M, Sasakawa H, Otaki S, Satoh M, Shitara K, Kato K,. 2007. Structural comparison of fucosylated and nonfucosylated Fc fragments of human immunoglobulin G1. J Mol Biol 368 (3): 767-779.
15. Masuda K, Kubota T, Kaneko E, Iida S, Wakitani M, Kobayashi-Natsume Y, Kubota A, Shitara K, Nakamura K,. 2007. Enhanced binding affinity for Fc gamma RIIIa of fucose-negative antibody is sufficient to induce maximal antibody-dependent cellular cytotoxicity. Mol Immunol 44 (12): 3122-3131.
16. Shinkawa T, Nakamura K, Yamane N, Shoji-Hosaka E, Kanda Y, Sakurada M, Uchida K, Anazawa H, Satoh M, Yamasaki M, Hanai N, Shitara K,. 2003. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J Biol Chem 278 (5): 3466-3473.
17. International Conference on Harmonisation 2009. Pharmaceutical Development Q8(R2) step 4.
18. Rathore AS, Winkle H,. 2009. Quality by design for biopharmaceuticals. Nat Biotechnol 27 (1): 26-34.
19. Shah RB, Park JT, Read E, Khan M, Brorson K,. 2009. Quality by design (QbD), biopharmaceutical manufacture. In Encyclopedia of industrial biotechnology: Bioprocess, bioseparation, and cell technology;, Flickinger M, Ed. Online: John Wiley & Sons, pp 1-36.
20. Mitschelen J, Short C, VanStraten P, Peterson J, Graniello R, Conner J, Perry S, Lightholder J,. 2008. Successful transfer and 200-fold scale-up of a r-CHO cell fed-batch process using a new cGMP compliant basal and feed medium combination. Cytovance Biologics. Accessed on, 8/13/14 at: http://www.bioprocessonline.com/doc/r-cho-cell-fed-batch-process-0001.
21. Abu-Absi SF, Yang L, Thompson P, Jiang C, Kandula S, Schilling B, Shukla AA,. 2010. Defining process design space for monoclonal antibody cell culture. Biotechnol Bioeng 106 (6): 894-905.
22. Montgomery DC,. 2006. Two-level fractional factorial designs. In Design and analysis of experiments. 6th ed. New Jersey: Wiley, pp 282-346.
23. Awotwe-Otoo D, Agarabi C, Faustino PJ, Habib MJ, Lee S, Khan MA, Shah RB,. 2012. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. J Pharm Biomed Anal 62: 61-67.
24. Xu XM, Khan MA, Burgess DJ,. 2012. A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale. Int J Pharm 423 (2): 543-553.
25. Rahman Z, Zidan AS, Habib MJ, Khan MA,. 2010. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm 389 (1-2): 186-194.
26. NIST. 2003. NIST/SEMATECH e-handbook of statistical methods. Accessed on, 7/29/14 at: http://www.itl.nist.gov/div898/handbook/index.htm.
27. Lee GM, Kim EJ, Kim NS, Yoon SK, Ahn YH, Song JY,. 1999. Development of a serum-free medium for the production of erythropoietin by suspension culture of recombinant Chinese hamster ovary cells using a statistical design. J Biotechnol 69 (2-3): 85-93.
28. Rubinstein LJ, Stein KE,. 1988. Murine immune response to the Neisseria meningitidis group C capsular polysaccharide. II. Specificity. J Immunol 141 (12): 4357-4362.
29. Kondragunta B, Drew JL, Brorson KA, Moreira AR, Rao G,. 2010. Advances in clone selection using high-throughput bioreactors. Biotechnol Prog 26 (4): 1095-1103.
30. Kondragunta B, Han J, Joshi BH, Brorson KA, Puri RK, Uplekar S, Moreira AR, Rao G,. 2012. Genomic analysis of a hybridoma batch cell culture metabolic status in a standard laboratory 5 L bioreactor. Biotechnol Prog 28 (5): 1126-1137.
31. Schiel JE, Au J, He HJ, Phinney KW,. 2012. LC-MS/MS biopharmaceutical glycoanalysis: Identification of desirable reference material characteristics. Anal Bioanal Chem 403 (8): 2279-2289.
32. Vallejos JR, Moreira AR, Rao G, Brorson K,. 2011. Integrating process scouting devices (PSDs) with bench-scale devices: Challenges and opportunities for mammalian cell culture. In Comprehensive biotechnology;, Moo-Young M, Ed. 2nd ed. Leiden, The Netherlands: Elsevier, pp 659-667.
33. 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 (11): 2600-2610.
34. Handa A, Emery AN, Spier RE,. 1987. On the evaluation of gas-liquid interfacial effects on hybridoma viability in bubble column bioreactors. Developments in biological standardization 66: 241-253 [PubMed]
35. Butler M, Huzel N,. 1995. The effect of fatty acids on hybridoma cell growth and antibody productivity in serum-free cultures. Journal of biotechnology 39 (2): 165-173 [PubMed]
36. Plackett RL, Burman JP,. 1946. The design of optimum multifactorial experiments. Biometrika 33 (4): 305-325.
37. Kisztelinski D, Alink GM, Rietjens IM, Bielecki S, Tramper J, Martens DE,. 2006. Application of a continuous bioreactor cascade to study the effect of linoleic acid on hybridoma cell physiology. Biotechnol Bioeng 95 (3): 370-383.
38. Butler M, Huzel N, Barnabe N,. 1997. Unsaturated fatty acids enhance cell yields and perturb the energy metabolism of an antibody-secreting hybridoma. Biochem J 322 (Pt 2): 615-623.
39. Legazpi L, Diaz J, Laca A, Diaz M,. 2005. Kinetic analysis of hybridoma cell culture in a protein-free medium: Substrate and agitation effects. Biochem Eng J 26 (2-3): 122-130.
40. Dowd JE, Kwok KE, Piret JM,. 2001. Glucose-based optimization of CHO-cell perfusion cultures. Biotechnol Bioeng 75 (2): 252-256.
41. Larson TM, Gawlitzek M, Evans H, Albers U, Cacia J,. 2002. Chemometric evaluation of on-line high-pressure liquid chromatography in mammalian cell cultures: Analysis of amino acids and glucose. Biotechnol Bioeng 77 (5): 553-563.
42. Gawlitzek M, Estacio M, Furch T, Kiss R,. 2009. Identification of cell culture conditions to control N-glycosylation site-occupancy of recombinant glycoproteins expressed in CHO cells. Biotechnol Bioeng 103 (6): 1164-1175.
43. Bollati-Fogolin M, Forno G, Nimtz M, Conradt HS, Etcheverrigaray M, Kratje R,. 2005. Temperature reduction in cultures of hGM-CSF-expressing CHO cells: Effect on productivity and product quality. Biotechnol Prog 21 (1): 17-21.
44. Yoon SK, Song JY, Lee GM,. 2003. Effect of low culture temperature on specific productivity, transcription level, and heterogeneity of erythropoietin in Chinese hamster ovary cells. Biotechnol Bioeng 82 (3): 289-298.
45. Kornfeld R, Kornfeld S,. 1985. Assembly of asparagine-linked oligosaccharides. Annu Rev Biochem 54: 631-664.
46. Read EK, Park JT, Brorson KA,. 2011. Industry and regulatory experience of the glycosylation of monoclonal antibodies. Biotechnol Appl Biochem 58 (4): 213-219.
47. 1H. Mol Immunol 32 (17-18): 1311-1318.
48. Hodoniczky J, Zheng YZ, James DC,. 2005. Control of recombinant monoclonal antibody effector functions by Fc N-glycan remodeling in vitro. Biotechnol Prog 21 (6): 1644-1652.
49. Altheide TK, Hayakawa T, Mikkelsen TS, Diaz S, Varki N, Varki A,. 2006. System-wide genomic and biochemical comparisons of sialic acid biology among primates and rodents: Evidence for two modes of rapid evolution. J Biol Chem 281 (35): 25689-25702.