PDADMAC flocculation of Chinese hamster ovary cells: Enabling a centrifuge-less harvest process for monoclonal antibodies

mAbs

Volumn 7, Issue 2, 2015, Pages 413-427

  McNerney, Thomas ^a   Thomas, Anne ^a   Senczuk, Anna ^a   Petty, Krista ^b   Zhao, Xiaoyang ^b   Piper, Rob ^a   Carvalho, Juliane ^b   Hammond, Matthew ^b   Sawant, Satin ^b   Bussiere, Jeanine ^b  

^a AMGEN INC   (United States)

^b AMGEN INC   (United States)

Author keywords

Cytotoxicity; In vitro hemolysis; In vivo rodent toxicity; Mammalian cell culture; Monoclonal antibody; Polycationic flocculation harvest; Reagent clearance

Indexed keywords

LACTIC ACID; MACROGOL; MONOCLONAL ANTIBODY; POLY(DIALLYLDIMETHYLAMMONIUM CHLORIDE); POLYCATION; POLYMER; MACROGOL DERIVATIVE; POLY-N,N-DIMETHYL-N,N-DIALLYLAMMONIUM CHLORIDE; POLYETHYLENE DERIVATIVE; POLYETHYLENE GLYCOL 1000; QUATERNARY AMMONIUM DERIVATIVE;

ANIMAL CELL; ARTICLE; CELL CULTURE; CELL DENSITY; CENTRIFUGE; CHEMICAL INTERACTION; CHO CELL LINE; CONTROLLED STUDY; CYTOTOXICITY; FEMALE; FLOCCULATION; HUMAN; HUMAN CELL; NONHUMAN; PARTICLE SIZE; RAT; ANIMAL; BIOSYNTHESIS; CENTRIFUGATION; CHEMISTRY; CRICETULUS; HAMSTER; ISOLATION AND PURIFICATION;

ANIMALS; ANTIBODIES, MONOCLONAL; CENTRIFUGATION; CHO CELLS; CRICETINAE; CRICETULUS; FLOCCULATION; HUMANS; POLYETHYLENE GLYCOLS; POLYETHYLENES; QUATERNARY AMMONIUM COMPOUNDS;

EID: 84924632831     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2015.1007824     Document Type: Article

References (40)

1. Iammarino M, Gyabaah JN, Chandler M, Roush D, Goklen K. Impact of cell density and viability on primary clarification of mammalian cell broth. BioProcess Int 2007; 5:38-50.
2. Kempken R, Preissman A, Berthold W. Assessment of a disc stack centrifuge for use in mammalian cell separation. Biotechnol Bioeng 1995; 46:132-8; PMID:18623272; http://dx.doi.org/10.1002/bit. 260460206
3. Roush DJ, Yuefeng L. Advances in primary recovery: Centrifugation and membrane technology. Biotechnol Prog 2008; 24:488-95; PMID:18410157; http://dx. doi.org/10.1021/bp070414x
4. Schirmer EB, Kuczewski M, Golden K, Lain B, Bragg C, Chon J, Caccluttolo M, Papastoitsis GZ. Primary clarification of very high-density cell culture harvests by enhanced cell settling. BioProcess Int 2010; 8:32-9.
5. Douwenga R. Moving to the next level of manufacturing. BioProcess Int, 2009 Online Educational Series. Raleigh, NC, Oct 14, 2009. Available from: http:// www.bpiseminars.com/Webcast/downloads/BPI- DSM-Webcast.pdf
6. Van der Bruggen B, Kim JH, DiGiano FA, Geens J, Vandecasteele C. Influence of MF pretreatment on NF performance for aqueous solutions containing particles and an organic foulant. Sep Purif Technol 2004; 36:203-13; http://dx.doi.org/10.1016/S1383-5866(03) 00216-8
7. Riske F, Schroeder J, Belliveau J, Kang X, Kutzko J, Menon MK. The use of chitosan as a flocculant in mammailian cell culture dramatically improves clarification throughput without adversely impacting monoclonal antibody recovery. J Biotechnol 2007; 128:813-23; PMID:17291617; http://dx.doi.org/10.1016/ j.jbiotec.2006.12.023
8. Aunins J, Wang DIC. Induced flocculation of animal cells in suspension culture. Biotechnol Bioeng 1989; 34:629-38; PMID:18588147; http://dx.doi.org/ 10.1002/bit.260340507
9. Kim JS, Akeprathumchai S, Wickramasinghe SR. Flocculation to enhance microfiltration. J Memb Sci 2001; 182:161-72; http://dx.doi.org/10.1016/S0376-7388 (00)00564-0
10. Hughes J, Ramsden DK, Symes KC. The flocculation of bacteria using cationic synthetic flocculants and chitosan. Biotechnol Tech 1990; 4:55-60; http://dx.doi. org/10.1007/BF00156611
11. Gregory J, Barany S. Adsorption and Flocculation by polymers and polymer mixtures. Adv Colloid Interface Sci 2011; 169:1-12; PMID:21762869; http://dx.doi. org/10.1016/j.cis.2011.06.004
12. Ramsden DK, Hughes J, Weir S. Flocculation of cellular material in complex fermentation medium with the flocculant poly (diallyldimethylammonium chloride). Biotechnol Tech 1998; 12:599-603
13. Kang Y, Hamzik J, Felo M, Qi B, Lee J, Ng S, Liebisch G, Shanehsaz B, Singh N, Persaud K, Ludwig DL, Balderes P. Development of a novel and efficient cell culture flocculation process using a stimulus responsive polymer to streamline antibody purification processes. Biotechnol Bioeng 2013; 110:2928-37; PMID:23740533; http://dx.doi.org/10.1002/bit.24969
14. Brostow W, Lobland HEH, Pal S, Singh RP. Settling rates for flocculation of iron and manganese ore-containing suspensions by cationic glycogen. Polym Eng Sci 2008; 48:1892-6; http://dx.doi.org/10.1002/ pen.21064
15. US Food and Drug Administration. Guidance for industry and FDA staff: class II special controls guidance document: wound dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) addition. FDA Center for Devices and Radiological Health,2009. Available from: http://www.fda.gov/Medical- Devices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm186571.htm
16. John W, Buckley CA, Jacobs EP, Sanderson RD. Synthesis and use of PolyDADMAC for water purification. Biennial Conference of the Water Institute of Southern Africa, Durban, South Africa, May 19-23, 2002. Available from: http://www.waterinformation.co.za/litera ture/files/127%20Paper.pdf
17. Bolto BA. Soluble polymers in water purification. Prog Pol Sci 1995; 20:987-1041; http://dx.doi.org/10.1016/ 0079-6700(95)00010-D
18. Fischer D, Li Y, Ahlemeyer B, Krieglstein J, Kissel T. In vitro cytotoxicity testing of polycations: influence of polymer structure on cell viability and hemolysis. Biomaterials 2003; 24:1121-31; PMID:12527253; http:// dx.doi.org/10.1016/S0142-9612(02)00445-3
19. Fischer D, Dautzenberg H, Kunath K, Kissel T. Poly (diallyldimethylammonium chorides) and their N-methyl- N-vinylacetamide copolymer-based DNA-polyplexes: role of molecular weight and charge density in complex formation, stability, and in vitro activity. Int J Pharm 2004; 280:253-69; PMID:15265564; http://dx. doi.org/10.1016/j.ijpharm.2004.05.018
20. Ravina L. Everything you want to know about coagulation & flocculation. Zeta-Meter, Inc., 1993. Available from: http://www.zeta-meter.com/coag.pdf
21. Senczuk A, Yigzaw, Y, Thomas A, Piper R, McNerney T. Particle distribution and cholesterol level aspredictors of cell culture flocculation and filterability performance. American Institute of Chemical Engineers, Puget Sound Local Section. Bothell, WA, Nov 16, 2010. Available from: http://www.aiche.org/com munity/sites/local-sections/puget-sound/events/novem ber-16-2010-meeting-anna-senczuk-amgen
22. Lekkerkerker HNW, Tuinier R. Colloids and the depletion interaction. Lecture Notes in Physics. Dordrecht: Springer; 2011.
23. Gibson T, McCarty K, McFadyen IJ, Cash E, Dalmonte P, Hinds KD, Dinerman AA, Alvarex JC, Volkin DB. Application of a high-throughput screening procedure with PEG-induced precipitation to compare relative protein solubility during formulation development with IgG1 monoclonal antibodies. J Pharm Sci 2011; 100:1009-21; PMID:21280052; http://dx.doi. org/10.1002/jps.22350
24. ICH (International Conference on Harmonization of Technical Requirements for Registration Pharmaceuticals for Human Use). Impurities in new drug substances Q3A (R2). Geneva, Switzerland; 2006. Available from: http://www.ich.org/products/guidelines/qual ity/quality-single/article/impurities-in-new-drug-sub stances.html
25. ICH (International Conference on Hamonization of Technical Requirements for Registration Pharmaceuticals for Human Use). Impurities in new drug products Q3B (R2). Geneva, Switzerland; 2006. Available from: http://www.ich.org/products/guidelines/quality/qual ity-single/article/impurities-in-new-drug-products.html
26. Majam S, Jonnalagadda SB, Thompson P. Development of analytical methods for organic polymer determination used in water treatment. Proceedings of the2004 Water Institute of Southern Africa (WISA) Biennial Conference, Cape Town, South Africa, May 2-6,2004. Available from: http://www.ewisa.co.za/litera ture/files/236.pdf
27. Slita AV, Kasyanenko NA, Nazarova OV, Garvrilova II, Eropkina EM, Sirotkin AK, Smirnova TD, Kiselev OI, Panarin EF. DNA-polycation complexes; Effect of polycation structure on physic-chemical and biological properties. J Biotechnol 2007; 127:679-93; PMID:16934901; http://dx.doi.org/10.1016/j.jbiotec. 2006.07.016
28. Schindler T, Nordmeier E. Denaturation experiments of calf-thymus DNA/polycation complexes in aqueous/ organic solvent mixtures. Polymer 1999; 40:7019-27; http://dx.doi.org/10.1016/S0032-3861(99)00057-9
29. Farrah S, Preston DR, Toranzos GA, Girard M, Erdos GA, Vasuhdivan V. Use of modified diatomaceous earth for removal and recovery of viruses in water. Appl Environ Microbiol 1991; 57:2502-6; PMID:1768124
30. Bauer D, Killmann E, JaegerW. Flocculation and stabilization of colloidal silica by adsorption of poly-diallyl-dimethyl- ammoniumchloride (PDADMAC and of copolymers of DADMAC with N-methyl-N-vinyl-acetamide (NMVA). Colloid Polym Sci 1998; 276:698-708; http:// dx.doi.org/10.1007/s003960050299
31. von Homeyer A, Krenta DO, Kulicke WM, Lerche D. Optimization of the polyelectrolyte dosage for dewatering sewage sludge suspensions by means of a new centrifugation analyser with an optoelectronic sensor. Colloid Polym Sci 1999; 277:637-45; http://dx.doi. org/10.1007/s003960050435
32. Schwartz L. Diafiltration for desalting or buffer exchange. BioProcess Int 2003; 1:43-9.
33. Asenjo J, Andrews BA. Aqueous two-phase systems for protein separation: phase separation and applications. J Chromatogr A 2012; 1238:1-10; PMID:22494642; http://dx.doi.org/10.1016/j.chroma.2012.03.049
34. Altman S, Randers L, Rao G. Compariosn of trypan blue dye exclusion and fluorometic assays for mammalian cell viability determinations. Biotechnol Prog 1993; 9:671-4; PMID:7764357; http://dx.doi.org/ 10.1021/bp00024a017
35. Compton B, LewisMA,WhighamF,Gerald JS, Countryman GE. Analytical potential of protein A for affinity chromatography of polyclonal and monoclonal antibodies. Anal Chem 1989; 61:1314-7; PMID:2774191; http://dx.doi. org/10.1021/ac00188a003
36. Yigzaw Y, Piper R, Tran M, Shukla AA. Exploitation of the adsorptive properities of depth filters for host cell protein removal during monoclonal antibody purification. Biotechnol Prog 2006; 22:288- 96; PMID:16454522; http://dx.doi.org/10.1021/ bp050274w
37. Dillion T, Ricci MS, Vezina C, Flynn GC, Liu YD, Rehder DS, Plant M, Henkle B, Li Y, Deechongkit S, Varnum B, Wypych J, Balland A, Bondarenko PV. Structural and functional characterization of disulfide isoforms of human IgG2 subclass. J Biol Chem 2008; 283:16206-15; PMID:18339626; http://dx.doi.org/ 10.1074/jbc.M709988200
38. Wypch J, Li M, Guo A, Zhang Z, Martinez T, Allen MJ, Fodor S, Kelner DN, Flynn GC, Liu YD, Bondarenko PV, Ricci MS, Dillion TM, Balland A. Human IgG2 antibodies display disulfide-mediated structural isoforms. J Biol Chem 2008; 283:16194-205; PMID:18339624; http://dx.doi.org/10.1074/jbc. M709987200
39. Martinez T, Guo, A, Allen, MJ, Han, M, Pace, D, Jones, J, Gillespie, R, Ketchem, RR, Zhang Y, Balland A. Disulfide connectivity of human immunoglobulin G2 structural isoforms. Biochemistry 2008; 47:7496- 508; PMID:18549248; http://dx.doi.org/10.1021/ bi800576c
40. nd ed. Bethesda, MD: Author;2002. http://www.grants.nih.gov/grants/olaw/guide book.pdf