Characterization of monoclonal antibody size variants containing extra light chains

mAbs

Volumn 5, Issue 1, 2013, Pages 102-113

  Lu, Connie ^a   Liu, Dandan ^a   Liu, Hongbin ^a   Motchnik, Paul ^a  

^a GENENTECH INC   (United States)

Author keywords

Antibody high molecular weight species; Antibody size variant; Light chain dimer; Monoclonal antibody; Size Exclusion Chromatography; Triple light chain antibody variant

Indexed keywords

CYSTEINE; GLUTATHIONE; IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; MONOMER; THIOL;

ANIMAL CELL; ANTIBODY STRUCTURE; ANTIGEN BINDING; ARTICLE; BINDING SITE; CAPILLARY ELECTROPHORESIS; CARBOXY TERMINAL SEQUENCE; CELL CLONE; DISULFIDE BOND; ELECTROSPRAY MASS SPECTROMETRY; GEL PERMEATION CHROMATOGRAPHY; LIGHT CHAIN; LIQUID CHROMATOGRAPHY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MICROFLUIDIC ANALYSIS; NONHUMAN; POLYACRYLAMIDE GEL ELECTROPHORESIS; STEREOSPECIFICITY;

ANIMALS; ANTIBODIES, MONOCLONAL; CHO CELLS; CHROMATOGRAPHY, GEL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CRICETINAE; DIMERIZATION; ELECTROPHORESIS, POLYACRYLAMIDE GEL; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN LIGHT CHAINS; MASS SPECTROMETRY; PEPTIDE MAPPING;

EID: 84872861595     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.22965     Document Type: Article

References (23)

1. Cordoba-Rodriguez RV. Aggregates in MAbs and recombinant therapeutic proteins: a regulatory perspective. BioPharm International 2008; 21:44-53
2. Cordoba AJ, Shyong BJ, Breen D, Harris RJ Non-enzymatic hinge region fragmentation of antibodies in solution. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 818:115-21; PMID:15734150; http://dx.doi.org/10.1016/j.jchromb. 2004.12.033
3. Xiang T, Lundell E, Sun Z., Liu H. Structural effect of a recombinant monoclonal antibody on hinge region peptide bond hydrolysis. J Chromatogr B Analyt Technol Biomed Life Sci 2007; 858:254-62; PMID:17901002; http://dx.doi.org/10.1016/j.jchromb.2007.08.043
4. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:E501-7; PMID:17025268; http://dx.doi.org/10.1208/aapsj080359
5. Rosenberg AS, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 2: considering host-specific and product-specific factors impacting immunogenicity. BioPharm International, 2004; http://www.biopharminternational.com/biopharm/21+CFR+Part+11/A-Risk-Based- Approach-to-Immunogenicity-Concerns-o/ArticleStandard/Article/detail/140695
6. Schenerman MA, Sunday BR, Kozlowski S, Webber K., Gazzano-Santoro H, Mire-Sluis A. CMC strategy forum report: analytical and structural characterization of monoclonal antibodies. BioProcess International 2004; 2:42-52
7. nd edition
8. Wyatt PJ. Light scattering and the absolute characterization of macromolecules. Anal Chim Acta 1993; 272: 1-40; http://dx.doi.org/10.1016/0003- 2670(93)80373-S
9. Ye H. Simultaneous determination of protein aggregation, degradation, and absolute molecular weight by size exclusion chromatography-multiangle laser light scattering. Anal Biochem 2006; 356:76-85; PMID:16839514; http://dx.doi.org/10.1016/j.ab.2006.05.025
10. Garfin DE. Essential Cell Biology Volume 1: Cell structure, a practical approach. In: Davey J and Lord M, eds. Gel Electrophoresis of Proteins. Oxford, UK: Oxford University Press, 2003:197-268
11. Vasilyeva E, Woodard J, Taylor F.R., Kretschmer M., Fajardo H, Lyubarskaya Y, et al Development of a chip-based capillary gel electrophoresis method for quantification of a half-antibody in immunoglobulin G4 samples. Electrophoresis 2004; 25:3890-6; PMID:15565674; http://dx.doi.org/10.1002/elps. 200406084
12. Hsieh J.F., Chen ST Comparative studies on the analysis of glycoproteins and lipopolysaccharides by the gelbased microchip and SDS-PAGE. Biomicrofluidics 2007; 1:14102; PMID:19693351; http://dx.doi.org/10.1063/1.2399892
13. Performance characteristics of the high sensitivity protein 250 assay for the Agilent 2100 Bioanalyzer. Agilent Technologies Technical Note 2008; 5989-8940EN
14. Zhang Z, Pan H, Chen X. Mass spectrometry for structural characterization of therapeutic antibodies. Mass Spectrom Rev 2009; 28:147-76; PMID:18720354; http://dx.doi.org/10.1002/mas.20190
15. Chen L, Gieschen A, Kilby G W, Lau J. Antibody Analysis by ESI-TOF LC/MS. Agilent Technologies Application Note 2007; 5989-5893EN. Www.chem.agilent.com/ Library/applications/5989-5893EN.pdf
16. Eon-Duval A., Broly H, Gleixner R. Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach. Biotechnol Prog 2012; 28:608-22; PMID:22473974; http://dx.doi.org/10.1002/btpr.1548
17. Edelman GM, Cunningham BA, Gall W.E., Gottlieb PD, Rutishauser U, Waxdal MJ The covalent structure of an entire gammaG immunoglobulin molecule. Proc Natl Acad Sci U S A 1969; 63:78-85; PMID:5257969; http://dx.doi.org/10.1073/pnas.63. 1.78
18. Liu H, Chumsae C, Gaza-Bulseco G, Hurkmans K., Radziejewski CH Ranking the susceptibility of disulfide bonds in human IgG1 antibodies by reduction, differential alkylation, and LC-MS analysis. Anal Chem 2010; 82:5219-26; PMID:20491447; http://dx.doi.org/10.1021/ac100575n
19. Wang Y, Lu Q, Wu S.L., Karger BL, Hancock WS Characterization and comparison of disulfide linkages and scrambling patterns in therapeutic monoclonal antibodies: using LC-MS with electron transfer dissociation. Anal Chem 2011; 83:3133-40; PMID:21428412; http://dx.doi.org/10.1021/ac200128d
20. Gomez N, Vinson AR, Ouyang J, Nguyen MDH, Chen XN, Sharma V.K., et al Triple light chain antibodies: factors that influence its formation in cell culture. Biotechnol Bioeng 2010; 105:748-60; PMID:19845001
21. O'Callaghan P.M., McLeod J, Pybus L P, Lovelady CS, Wilkinson S.J., Racher AJ, et al Cell line-specific control of recombinant monoclonal antibody production by CHO cells. Biotechnol Bioeng 2010; 106:938-51; PMID:20589672; http://dx.doi.org/10.1002/bit.22769
22. Stevens FJ, Schiffer M. Chapter 3: Structure and properties of human immunoglobulin light-chain dimers. In: Paul S, ed. Methods m Molecular Biology, Vol 51 Antibody Engineering Protocols. Totowa, NJ: Humana Press Inc. Humana Press Inc. 1995:51-81
23. Stevens FJ, Westholm FA, Solomon A, Schiffer M. Self-association of human immunoglobulin kappa I light chains: role of the third hypervariable region. Proc Natl Acad Sci U S A 1980; 77:1144-8; PMID:6767243; http://dx.doi.org/10. 1073/pnas.77.2.1144