A clone screening method using mRNA levels to determine specific productivity and product quality for monoclonal antibodies

Biotechnology and Bioengineering

Volumn 102, Issue 4, 2009, Pages 1107-1118

  Lee, Christina J ^a   Seth, Gargi ^a   Tsukuda, Joni ^a   Hamilton, Robert W ^a  

^a GENENTECH INC   (United States)

Author keywords

Antibody aggregation; Chinese hamster ovary cells; Clone screening; mRNA; Specific productivity

Indexed keywords

ANTIBODY AGGREGATION; CHINESE HAMSTER OVARY CELLS; CLONE SCREENING; MRNA; SPECIFIC PRODUCTIVITY;

CELL CULTURE; MEATS; MONOCLONAL ANTIBODIES; PRODUCTIVITY; QUALITY CONTROL;

CLONING;

MESSENGER RNA; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ANIMAL CELL; ARTICLE; CELL LYSATE; CHO CELL; CLONE; DEVICE; NONHUMAN; QUALITY CONTROL; SCREENING; ANIMAL; BIOSYNTHESIS; CHEMISTRY; CRICETULUS; CULTURE TECHNIQUE; GENETICS; HAMSTER; METHODOLOGY;

CRICETULUS GRISEUS;

ANIMALS; ANTIBODIES, MONOCLONAL; CELL CULTURE TECHNIQUES; CHO CELLS; CRICETINAE; CRICETULUS; RECOMBINANT PROTEINS; RNA, MESSENGER;

EID: 60549105996     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22126     Document Type: Article

References (32)

1. Andersen DC, Krummen L. 2002. Recombinant protein expression for therapeutic applications. Curr Opin Biotechnol 13(2):117-123.
2. Barnes LM, Dickson AJ. 2006. Mammalian cell factories for efficient and stable protein expression. Curr Opin Biotechnol 17(4):381-386.
3. Bustin SA. 2000. Absolute quantification of mRNA using real-time reverse transcription polymerase chain reaction assays. J Mol Endocrinol 25(2):169-193.
4. Butler M. 2005. Animal cell cultures: Recent achievements and perspectives in the production of biopharmaceuticals. Appl Microbiol Biotechnol 68(3):283-291.
5. Canales RD, Luo Y, Willey JC, Austermiller B, Barbacioru CC, Boysen C, Hunkapiller K, Jensen RV, Knight CR, Lee KY, et al. 2006. Evaluation of DNA microarray results with quantitative gene expression platforms. Nat Biotech 24(9):1115-1122.
6. Cromwell MEM, Hilario E, Jacobson F. 2006. Protein aggregation and bioprocessing. AAPS J 8(3):E572-E579.
7. de la Cruz Edmonds MC, Tellers M, Chan C, Salmon P, Robinson DK, Markusen J. 2006. Development of transfection and high-producer screening protocols for the CHOK1SV cell system. Mol Biotechnol 34(2):179-190.
8. DeMaria CT, Cairns V, Schwarz C, Zhang J, Guerin M, Zuena E, Estes S, Karey KP. 2007. Accelerated clone selection for recombinant CHO cells using a FACS-based high-throughput screen. Biotechnol Prog 23(2): 465-472.
9. Dinnis DM, James DC. 2005. Engineering mammalian cell factories for improved recombinant monoclonal antibody production: Lessons from nature? Biotechnol Bioeng 91(2):180-189.
10. Dorai H, Csirke B, Scallon B, Ganguly S. 2006. Correlation of heavy and light chain mRNA copy numbers to antibody productivity in mouse myeloma production cell lines. Hybridoma 25(1):1-9.
11. Dydensborg AB, Herring E, Auclair J, Tremblay E, Beaulieu JF. 2006. Normalizing genes for quantitative RT-PCR in differentiating human intestinal epithelial cells and adenocarcinomas of the colon. Am J Physiol Gastrointest Liver Physiol 290(5):G1067-G1074.
12. Flagella M, Bui S, Zheng Z, Nguyen CT, Zhang A, Pastor L, Ma Y, Yang W, Crawford KL, McMaster GK, et al. 2006. A multiplex branched DNA assay for parallel quantitative gene expression profiling. Anal Biochem 352(1):50-60.
13. Freyer SA, Konig M, Kunkel A. 2004. Validating shaking flasks as representative screening systems. Biochem Eng J 17(3):169-173.
14. Fussenegger M, Bailey JE, Hauser H, Mueller PP. 1999. Genetic optimization of recombinant glycoprotein production by mammalian cells. Trends Biotechnol 17(1):35-42.
15. Hamalainen HK, Tubman JC, Vikman S, Kyrola T, Ylikoski E, Warrington JA, Lahesmaa R. 2001. Identification and validation of endogenous reference genes for expression profiling of T helper cell differentiation by quantitative real-time RT-PCR. Anal Biochem 299(1): 63-70.
16. Jiang Z, Huang Y, Sharfstein ST. 2006. Regulation of recombinant monoclonal antibody production in Chinese hamster ovary cells: A comparative study of gene copy number, mRNA level, and protein expression. Biotechnol Prog 22(1):313-318.
17. Kumar S, Wittmann C, Heinzle E. 2004. Minibioreactors. Biotechnol Lett 26(1):1-10.
18. Lattenmayer C, Trummer E, Schriebl K, Vorauer-Uhl K, Mueller D, Katinger H, Kunert R. 2007. Characterisation of recombinant CHO cell lines by investigation of protein productivities and genetic parameters. J Biotechnol 128(4):716-725.
19. Lenny N, Green M. 1991. Regulation of endoplasmic reticulum stress proteins in COS cells transfected with immunoglobulin mu heavy chain cDNA. J Biol Chem 266(30):20532-20537.
20. Liu C, Hong L. 2001. Development of a shaking bioreactor system for animal cell cultures. Biochem Eng J 7(2):121-125.
21. Liu J, Andya JD, Shire SJ. 2006. A critical review of analytical ultracen-trifugation and field flow fractionation methods for measuring protein aggregation. AAPS J 8(3):E580-E589.
22. Philo JS. 2006. Is any measurement method optimal for all aggregate sizes and types? AAPS J 8(3):E564-E571.
23. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8(3):E501-E507.
24. Schlatter S, Stansfield SH, Dinnis DM, Racher AJ, Birch JR, James DC. 2005. On the optimal ratio of heavy to light chain genes for efficient recombinant antibody production by CHO Cells. Biotechnol Prog 21(1):122-133.
25. Schmittgen TD, Zakrajsek BA. 2000. Effect of experimental treatment on housekeeping gene expression: Validation by real-time, quantitative RT-PCR. J Biochem Biophys Methods 46(1-2):69-81.
26. Thellin O, Zorzi W, Lakaye B, De Borman B, Coumans B, Hennen G, Grisar T, Igout A, Heinen E. 1999. Housekeeping genes as internal standards: Use and limits. J Biotechnol 75(2-3):291-295.
27. Tsai SP, Wong A, Mai E, Chan P, Mausisa G, Vasser M, Jhurani P, Jakobsen MH, Wong WLT, Stephan J-P. 2003. Nucleic acid capture assay, a new method for direct quantitation of nucleic acids. Nucl Acids Res 31(6):e25.
28. Vandecasteele SJ, Peetermans WE, Merckx R, Van Eldere J. 2001. Quantification of expression of Staphylococcus epidermidis housekeeping genes with Taqman quantitative PCR during in vitro growth and under different conditions. J Bacteriol 183(24):7094-7101.
29. Vandesompele J, De Preter K, Pattyn F, Poppe B, Van Roy N, De Paepe A, Speleman F. 2002. Accurate normalization of real-time quantitative RT-PCR data by geometric averaging of multiple internal control genes. Genome Biol 3(7):RESEARCH0034.
30. Vanhove M, Usherwood YK, Hendershot LM. 2001. Unassembled Ig heavy chains do not cycle from BiP in vivo but require light chains to trigger their release. Immunity 15(1):105-114.
31. Wurm FM. 2004. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotech 22(11):1393-1398.
32. Zhang A, Pastor L, Nguyen Q, Luo Y, Yang W, Flagella M, Chavli R, Bui S, Nguyen CT, Zheng Z, et al. 2005. Small interfering RNA and gene expression analysis using a multiplex branched DNA assay without RNA purification. J Biomol Screen 10(6):549-556.