Production of a complement inhibitor possessing sialyl Lewis X moieties by in vitro glycosylation technology

Glycobiology. 2004 Oct;14(10):883-93. doi: 10.1093/glycob/cwh112. Epub 2004 Jun 9.

Abstract

Recombinant soluble human complement receptor type 1 (sCR1) is a highly glycosylated glycoprotein intended for use as a drug to treat ischemia-reperfusion injury and other complement-mediated diseases and injuries. sCR1-sLe(x) produced in the FT-VI-expressing mutant CHO cell line LEC11 exists as a heterogeneous mixture of glycoforms, a fraction of which include structures with one or more antennae terminated by the sialyl Lewis X (sLe(x)) [Neu5Acalpha2-3Galbeta1-4(Fucalpha1-3)GlcNAc]) epitope. Such multivalent presentation of sLe(x) was shown previously to effectively target sCR1 to activated endothelial cells expressing E-selectin. Here, we describe the use of the soluble, recombinant alpha2-3 sialyltransferase ST3Gal-III and the alpha1-3 fucosyltransferase FT-VI in vitro to introduce sLe(x) moieties onto the N-glycan chains of sCR1 overexpressed in standard CHO cell lines. The product (sCR1-S/F) of these in vitro enzymatic glycan remodeling reactions performed at the 10-g scale has approximately 14 N-glycan chains per sCR1 molecule, comprised of biantennary (90%), triantennary (8.5%), and tetraantennary (1.5%) structures, nearly all of whose antennae terminate with sLe(x) moieties. sCR1-S/F retained complement inhibitory activity and, in comparison with sCR1-sLe(x) produced in the LEC11 cell line, contained twice the number of sLe(x) moieties per mole glycoprotein, exhibited a twofold increase in area under the intravenous clearance curve in a rat pharmacokinetic model, and exhibited a 10-fold increase in affinity for E-selectin in an in vitro binding assay. These results demonstrate that in vitro glycosylation of the sCR1 drug product reduces heterogeneity of the glycan profile, improves pharmacokinetics, and enhances carbohydrate-mediated binding to E-selectin.

MeSH terms

  • Animals
  • CHO Cells
  • Cricetinae
  • E-Selectin / metabolism
  • Fucosyltransferases / metabolism
  • Fucosyltransferases / pharmacology
  • Glycosylation
  • Humans
  • Oligosaccharides / chemistry*
  • Oligosaccharides / genetics
  • Oligosaccharides / metabolism
  • Polysaccharides / chemistry
  • Polysaccharides / genetics
  • Polysaccharides / metabolism
  • Rats
  • Receptors, Complement / biosynthesis*
  • Receptors, Complement / chemistry*
  • Receptors, Complement / genetics
  • Receptors, Complement / metabolism
  • Recombinant Proteins / chemistry
  • Recombinant Proteins / genetics
  • Recombinant Proteins / metabolism
  • Sialyl Lewis X Antigen
  • Sialyltransferases / chemistry
  • Sialyltransferases / metabolism
  • Sialyltransferases / pharmacology
  • beta-Galactoside alpha-2,3-Sialyltransferase

Substances

  • E-Selectin
  • Oligosaccharides
  • Polysaccharides
  • Receptors, Complement
  • Recombinant Proteins
  • Sialyl Lewis X Antigen
  • soluble complement inhibitor 1
  • Fucosyltransferases
  • Sialyltransferases
  • beta-Galactoside alpha-2,3-Sialyltransferase