N-glycan PK Profiling Using a High Sensitivity nanoLCMS Work-Flow with Heavy Stable Isotope Labeled Internal Standard and Application to a Preclinical Study of an IgG1 Biopharmaceutical

Pharmaceutical Research

Volumn 32, Issue 11, 2015, Pages 3649-3659

  Higel, Fabian ^a   Seidl, Andreas ^a   Demelbauer, Uwe ^f   Viertlboeck Schudy, Margot ^a   Koppenburg, Vera ^a   Kronthaler, Ulrich ^b   Sörgel, Fritz ^c,d   Frieß, Wolfgang ^e  

^a Sandoz Biopharmaceuticals   (Germany)

^b Sandoz Pharma Ltd   (Switzerland)

^c IBMP (Institute of Biomedical and Pharmaceutical Research)   (Germany)

^d UNIVERSITY OF DUISBURG ESSEN   (Germany)

^e UNIVERSITY OF MUNICH   (Germany)

^f Process Analytics Sandoz Biopharmaceuticals   (Austria)

Author keywords

high mannose; mass spectrometry; monoclonal antibody; N glycosylation; pharmacokinetics

Indexed keywords

AMINOBENZOIC ACID C 13; GLYCAN DERIVATIVE; IMMUNOGLOBULIN G1 ANTIBODY; RADIOPHARMACEUTICAL AGENT; UNCLASSIFIED DRUG; CARBON; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; POLYSACCHARIDE;

AFFINITY PURIFICATION; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; ELIMINATION HALF-LIFE; ENZYME LINKED IMMUNOSORBENT ASSAY; GLYCOSYLATION; ISOTOPE LABELING; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NEW ZEALAND WHITE (RABBIT); NONHUMAN; PRIORITY JOURNAL; PURIFICATION; REFERENCE VALUE; STANDARD; TIME TO MAXIMUM PLASMA CONCENTRATION; ANIMAL; ANTIBODY AFFINITY; BLOOD; CHEMISTRY; PHARMACEUTICS; PRECLINICAL STUDY; PROCEDURES; RABBIT; SUBCUTANEOUS DRUG ADMINISTRATION; WORKFLOW;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY AFFINITY; BIOPHARMACEUTICS; CARBON ISOTOPES; CHROMATOGRAPHY, LIQUID; DRUG EVALUATION, PRECLINICAL; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOGLOBULIN G; INJECTIONS, SUBCUTANEOUS; LIMIT OF DETECTION; MASS SPECTROMETRY; POLYSACCHARIDES; RABBITS; REFERENCE STANDARDS; WORKFLOW;

EID: 84943581183     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-015-1724-0     Document Type: Article

References (24)

1. Li H, d'Anjou M. Pharmacological significance of glycosylation in therapeutic proteins. Curr Opin Biotechnol. 2009;20:678-84.
2. Putnam WS, Prabhu S, Zheng Y, Subramanyam M, Wang Y-MC. Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies. Trends Biotechnol. Elsevier Ltd. 2010;28:509-16.
3. Correia IR. Stability of IgG isotypes in serum. MAbs. 2010;2:221-32.
4. Newkirk MM, Novick J, Stevenson MM, Fournier MJ, Apostolakos P. Differential clearance of glycoforms of IgG in normal and autoimmune-prone mice. Clin Exp Immunol. 1996;106:259-64.
5. Millward TA, Heitzmann M, Bill K, Längle U, Schumacher P, Forrer K. Effect of constant and variable domain glycosylation on pharmacokinetics of therapeutic antibodies in mice. Biologicals. 2008;36:41-7.
6. Chen X, Liu YD, Flynn GC. The effect of Fc glycan forms on human IgG2 antibody clearance in humans. Glycobiology. 2009;19:240-9.
7. Goetze AM, Liu YD, Zhang Z, Shah B, Lee E, Bondarenko PV, et al. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology. 2011;21:949-59.
8. Yu M, Brown D, Reed C, Chung S, Lutman J. Production, characterization, and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans. MAbs. 2012;1-13.
9. Alessandri L, Ouellette D, Acquah A. Increased serum clearance of oligomannose species present on a human IgG1 molecule. MAbs. 2012;1-12.
10. Liu L, Stadheim A, Hamuro L, Pittman T, Wang W, Zha D, et al. Pharmacokinetics of IgG1 monoclonal antibodies produced in humanized Pichia pastoris with specific glycoforms: a comparative study with CHO produced materials. Biologicals. Elsevier Ltd; 2011;39:205-10.
11. Ashwell G, Harford J. Carbohydrate-specific receptors of the liver. Annu Rev Biochem. 1982;51:531-54.
12. Stockert RJ. The asialoglycoprotein receptor: relationships between structure, function, and expression. Physiol Rev. 1995;75:591-609.
13. Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313:670-3.
14. Kogelberg H, Tolner B, Sharma SK, Lowdell MW, Qureshi U, Robson M, et al. Clearance mechanism of a mannosylated antibody-enzyme fusion protein used in experimental cancer therapy. Glycobiology. 2007;17:36-45.
15. Allavena P, Chieppa M, Monti P, Piemonti L. From pattern recognition receptor to regulator of homeostasis: the double-faced macrophage mannose receptor. Crit Rev Immunol. 2004;24:179-92.
16. Lee SJ, Evers S, Roeder D, Parlow AF, Risteli J, Risteli L, et al. Mannose receptor-mediated regulation of serum glycoprotein homeostasis. Science. 2002;295:1898-901.
17. Taylor PR, Gordon S, Martinez-Pomares L. The mannose receptor: linking homeostasis and immunity through sugar recognition. Trends Immunol. 2005;26:104-10.
18. Gorovits B, Krinos-Fiorotti C. Proposed mechanism of off-target toxicity for antibody-drug conjugates driven by mannose receptor uptake. Cancer Immunol Immunother. 2013;62:217-23.
19. Higel F, Demelbauer U, Seidl A, Friess W, Sörgel F. Reversed-phase liquid-chromatographic mass spectrometric N-glycan analysis of biopharmaceuticals. Anal Bioanal Chem. 2013;405:2481-93.
20. Prien JM, Prater BD, Cockrill SL. A multi-method approach toward de novo glycan characterization: a Man-5 case study. Glycobiology. 2010;20:629-47.
21. Higel F, Seidl A, Demelbauer U, Sörgel F, Frieß W. Small scale affinity purification and high sensitivity reversed phase nanoLC-MS N-glycan characterization of mAbs and fusion proteins. MAbs. 2014;6:894-903.
22. McCurdy TR, Bhakta V, Eltringham-Smith LJ, Gataiance S, Fox-Robichaud AE, Sheffield WP. In vivo clearance of alpha-1 acid glycoprotein is influenced by the extent of its N-linked glycosylation and by its interaction with the vessel wall. J Biomed Biotechnol. 2012;2012:292730.
23. Krapp S, Mimura Y, Jefferis R, Huber R, Sondermann P. Structural analysis of human IgG-Fc glycoforms reveals a correlation between glycosylation and structural integrity. J Mol Biol. 2003;325:979-89.
24. Masuda K, Yamaguchi Y, Kato K, Takahashi N, Shimada I, Arata Y. Pairing of oligosaccharides in the Fc region of immunoglobulin G. FEBS Lett. 2000;473:349-57.