Characterization of glycoprotein biopharmaceutical products by caliper LC90 CE-SDS gel technology

Methods in Molecular Biology

Volumn 988, Issue , 2013, Pages 199-209

  Chen, Grace ^a   Ha, Sha ^a   Rustandi, Richard R ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Caliper GX GXII; Caliper LC90; CE SDS gel; EPO; Fc fusion protein; Glycoprotein characterization; High throughput methods; Molecular weight; Monoclonal antibody; N linked glycan occupancy

Indexed keywords

ERYTHROPOIETIN; GLYCOSYLATED PROTEIN; HEAVILY GLYCOSYLATED FC FUSION PROTEIN; HYBRID PROTEIN; MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG; GLYCOPEPTIDASE; GLYCOPROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ARTICLE; CALIPER; CAPILLARY ELECTROPHORESIS; CAPILLARY ELECTROPHORESIS SODIUM DODECYL SULFATE GEL ELECTROPHORESIS; CONTROLLED STUDY; GEL ELECTROPHORESIS; MOLECULAR WEIGHT; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEIN GLYCOSYLATION; CHEMISTRY; METHODOLOGY; PROTEIN MICROARRAY; SPECTROFLUOROMETRY; STANDARD;

ELECTROPHORESIS, CAPILLARY; ELECTROPHORESIS, POLYACRYLAMIDE GEL; ERYTHROPOIETIN; GLYCOPROTEINS; IMMUNOGLOBULIN FC FRAGMENTS; PEPTIDE-N4-(N-ACETYL-BETA-GLUCOSAMINYL) ASPARAGINE AMIDASE; PROTEIN ARRAY ANALYSIS; RECOMBINANT FUSION PROTEINS; REFERENCE STANDARDS; SPECTROMETRY, FLUORESCENCE;

EID: 84883024756     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-62703-327-5_12     Document Type: Article

References (19)

1. Gibbons RA (1972) Physico-chemical methods for the determination of the purity, molecular size and shape of glycoproteins. Chapter 3, Section 1. In: Gottschalk A (ed) Glycoproteins their composition, structure and function, vol. 5, Elsevier Publishing Company, Amsterdam, pp. 31-128
2. Leach BS, Collawn JF, Fish WW (1980) Behavior of glycopolypeptides with empirical molecular weight estimation methods. Biochemistry 1980: 5734-5741
3. Durchschlag H, Christl P, Jaenicke R (1991) Comparative determination of the particle weight of glycoproteins by SDS-PAGE and analytical ultracentrifugation. Prog Colloid Polym Sci 86: 41-56
4. Pitt-Rivers R, Impiombato FSA (1968) The binding of sodium dodecyl sulphate to various proteins. Biochem J 109: 825-829
5. Reynolds JA, Tanford C (1970) The gross conformation of protein-sodium dodecyl sulfate complexes. J Biol Chem 245: 5161-5165
6. Guo XH, Chen SH (1990) The structure and thermodynamics of protein-SDS complexes in solution and the mechanism of their transports in gel electrophoresis process. Chem Phys 149: 129-139
7. Hunt G, Nashabeh W (1999) Capillary electrophoresis sodium dodecyl sulfate nongel sieving analysis of a therapeutic recombinant monoclonal antibody: a biotechnology perspective. Anal Chem 71: 2390-2397
8. Han M, Phan D, Nightlinger L, Taylor S (2006) Optimization of CE SDS method for antibody separation based on multi-users experimental practices. Chromatographia 64: 335-342
9. Rustandi RR, Washabaugh MW, Wang Y (2008) Applications of CE SDS gel in development of biopharmaceutical antibody-based products. Electrophoresis 29: 3612-3620
10. Bousse L, Mouradian S, Minalla A, Yee H, Williams K, Dubrow R (2001) Protein sizing on a microchip. Anal Chem 73: 1207-1212
11. Chen X, Tang K, Lee M, Flynn GC (2008) Microchip assays for screening monoclonal antibody product quality. Electrophoresis 29: 4993-5002
12. Chen X, Flynn GC (2009) A high throughput dimer screening assay for monoclonal antibodies using chemical cross-linking and microchip electrophoresis. J Chromatogr B Analyt Technol Biomed Life Sci 877: 3012-3018
13. Chow AW (2006) Protein separations. In: Henry CS (ed) Methods in molecular biology: microchip capillary electrophoresis methods and protocols, vol 339. Humana Press, Totowa, pp 145-158
14. Caliper Life Sciences (2008) LabChip® GX/GXII User Manual, P/N:127170 Rev. 00. http://www.perkinelmer.com/CMSResources/Images/44-133044MAN- LabChip%20GX. GX%20II%20User%20Manual.pdf
15. Mimura Y, Church S, Ghirlando R, Ashton PR, Dong S, Goodall M, Lund J, Jefferis R (2000) The influence of glycosylation on the thermal stability and effector function expression of human IgG1-Fc: properties of a series of truncated glycoforms. Mol Immunol 37: 697-706
16. Ha S, Ou Y, Vlasak J, Li Y, Wang S, Vo K, Du Y, Mach A, Fang Y, Zhang N (2011) Isolation and characterization of IgG1 with asymmetrical Fc glycosylation. Glycobiology 21: 1087-1096
17. Ma S, Nashabeh W (2001) Analysis of protein therapeutics by capillary electrophoresis. Chromatographia 53:S75-S89
18. Cohen SC, Price C, Vlasak J (2007) Betaelimination and peptide bond hydrolysis: two distinct mechanisms of human IgG1 hinge fragmentation upon storage. J Am Chem Soc 129: 6976-6977
19. Rustandi RR, Wang Y (2011) Use of CE-SDS gel for characterization of monoclonal antibody hinge region clipping due to copper and high pH stress. Electrophoresis 32: 3078-3084