Characterization of monoclonal antibody size variants containing extra light chains

References

• Cordoba-Rodriguez RV. Aggregates in MAbs and recombinant therapeutic proteins: a regulatory perspective. BioPharm International 2008; 21:44 - 53
   Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.jchromb.2004.12.033; PMID: 15734150
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.jchromb.2007.08.043; PMID: 17901002
   PubMed Web of Science ®Google Scholar
• Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:E501 - 7; http://dx.doi.org/10.1208/aapsj080359; PMID: 17025268
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   Google Scholar
• International Union of Pure and Applied Chemistry. Size-exclusion chromatography (SEC). Compendium of Chemical Terminology 1997, 2nd edition.
   Google Scholar
• Wyatt PJ. Light scattering and the absolute characterization of macromolecules. Anal Chim Acta 1993; 272:l - 40; http://dx.doi.org/10.1016/0003-2670(93)80373-S
   Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.ab.2006.05.025; PMID: 16839514
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• Vasilyeva E, Woodard J, Taylor FR, 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; http://dx.doi.org/10.1002/elps.200406084; PMID: 15565674
   PubMed Web of Science ®Google Scholar
• Hsieh JF, Chen ST. Comparative studies on the analysis of glycoproteins and lipopolysaccharides by the gel-based microchip and SDS-PAGE. Biomicrofluidics 2007; 1:14102; http://dx.doi.org/10.1063/1.2399892; PMID: 19693351
   PubMed Web of Science ®Google Scholar
• Performance characteristics of the high sensitivity protein 250 assay for the Agilent 2100 Bioanalyzer. Agilent Technologies Technical Note 2008; 5989-8940EN.
   Google Scholar
• Zhang Z, Pan H, Chen X. Mass spectrometry for structural characterization of therapeutic antibodies. Mass Spectrom Rev 2009; 28:147 - 76; http://dx.doi.org/10.1002/mas.20190; PMID: 18720354
   PubMed Web of Science ®Google Scholar
• Chen L, Gieschen A, Kilby GW, 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
   Google Scholar
• 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; http://dx.doi.org/10.1002/btpr.1548; PMID: 22473974
   PubMed Web of Science ®Google Scholar
• Edelman GM, Cunningham BA, Gall WE, 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; http://dx.doi.org/10.1073/pnas.63.1.78; PMID: 5257969
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1021/ac100575n; PMID: 20491447
   PubMed Web of Science ®Google Scholar
• Wang Y, Lu Q, Wu SL, 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; http://dx.doi.org/10.1021/ac200128d; PMID: 21428412
   PubMed Web of Science ®Google Scholar
• Gomez N, Vinson AR, Ouyang J, Nguyen MDH, Chen XN, Sharma VK, et al. Triple light chain antibodies: factors that influence its formation in cell culture. Biotechnol Bioeng 2010; 105:748 - 60; PMID: 19845001
   PubMed Web of Science ®Google Scholar
• O’Callaghan PM, McLeod J, Pybus LP, Lovelady CS, Wilkinson SJ, Racher AJ, et al. Cell line-specific control of recombinant monoclonal antibody production by CHO cells. Biotechnol Bioeng 2010; 106:938 - 51; http://dx.doi.org/10.1002/bit.22769; PMID: 20589672
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• 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; http://dx.doi.org/10.1073/pnas.77.2.1144; PMID: 6767243
   PubMed Web of Science ®Google Scholar