Do YB2/0 cells produce alien sugars?

Olovnikova et al. ("Impact on N-glycosylation profile of monoclonal anti-D antibodies as a way to control their immunoregulatory and cytotoxic properties" (2012) Biochemistry (Moscow), 77, 925-933) mentioned the presence of "alien sugars" on monoclonal antibodies (mAbs) produced by YB2/0 cell line. We summarize in this paper our previous findings on the glycosylation profile of two anti-D mAbs produced in this cell line (LFB-R297 and LFB-R593, so-called Roledumab). Our results show the absence of any immunogenic glycotopes, and furthermore neither immunogenicity nor other serious adverse reactions were observed during clinical trials.

Pharmacokinetics and safety of roledumab, a novel human recombinant monoclonal anti-RhD antibody with an optimized Fc for improved engagement of FCγRIII, in healthy volunteers.

BACKGROUND AND OBJECTIVES: A human recombinant monoclonal anti-RhD IgG may be useful to prevent RhD allo-immunization. Roledumab is such an antibody with a glycosylation pattern optimized for biological activity. The objective of the study was to assess the safety and pharmacokinetics of roledumab in healthy RhD-negative volunteers. MATERIALS AND METHODS: A total of 46 subjects received doses of 30-3000 µg i.v. of roledumab or placebo using a double-blind escalating single-dose design; 12 of these subjects also received 300 µg i.m. of roledumab. Subjects were followed for 6 months after administration. Serum roledumab concentrations were determined using flow cytometry. RESULTS: Fourteen treatment-emergent adverse events related to treatment were reported in nine subjects, with no apparent difference in their frequency or nature after placebo or roledumab administration. No anti-roledumab antibodies were detected. AUC(last) increased from 4·4 ng/ml.day at 30 µg i.v. to 2257 ng/ml.day at 3000 g i.v. The t(½) ranged from 18 to 22 days, and the absolute bioavailability after i.m. administration was between 73% and 80%. CONCLUSION: Roledumab is safe and well tolerated in healthy RhD-negative volunteers and shows a pharmacokinetic profile similar to that of polyclonal anti-RhD immunoglobulin.