NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods.

摘要: Glycosylation is a topic of intense current interest in the development biopharmaceuticals because it related to drug safety and efficacy. This work describes results an interlaboratory study on glycosylation Primary Sample (PS) NISTmAb, monoclonal antibody reference material. Seventy-six laboratories from industry, university, research, government, hospital sectors Europe, North America, Asia, Australia submitted total 103 reports glycan distributions. The principal objective this was report compare for full range analytical methods presently used analysis mAbs. Therefore, participation unrestricted, with choosing their own measurement techniques. Protein determined various ways, including at level intact mAb, protein fragments, glycopeptides, or released glycans, using wide variety derivatization, separation, identification, quantification. Consequently, diversity enormous, number compositions identified by each laboratory ranging 4 48. In total, one hundred sixteen were reported, which 57 could be assigned consensus abundance values. These medians provide community-derived values NISTmAb PS. Agreement did not depend specific method type. provides view state-of-the-art biologic suggests clear need harmonization methods.