Investigators from Pfizer Report New Data on Immunoglobulins (Development and Application of a Robust N-Glycan Profiling Method for Heightened Characterization of Monoclonal Antibodies and Related Glycoproteins)
By a News Reporter-Staff News Editor at Drug Week -- Current study results on Immunology have been published. According to news reporting out of Pearl River, New York, by NewsRx editors, research stated, "A highly robust hydrophilic interaction liquid chromatography (HILIC) method that involves both fluorescence and mass spectrometric detection was developed for profiling and characterizing enzymatically released and 2-aminobenzamide (2-AB)-derivatized mAb N-glycans. Online HILIC/mass spectrometry (MS) with a quadrupole time-of-flight mass spectrometer provides accurate mass identifications of the separated, 2-AB-labeled N-glycans."
Our news journalists obtained a quote from the research from Pfizer, "The method features a high-resolution, low-shedding HILIC column with acetonitrile and water-based mobile phases containing trifluoroacetic acid (TFA) as a modifier. This column and solvent system ensures the combination of robust chromatographic performance and full compatibility and sensitivity with online MS in addition to the baseline separation of all typical mAb N-glycans. The use of TFA provided distinct advantages over conventional ammonium formate as a mobile phase additive, such as, optimal elution order for sialylated N-glycans, reproducible chromatographic profiles, and matching total ion current chromatograms, as well as minimal signal splitting, analyte adduction, and fragmentation during HILIC/MS, maximizing sensitivity for trace-level species. The robustness and selectivity of HILIC for N-glycan analyses allowed for method qualification. The method is suitable for bioprocess development activities, heightened characterization, and clinical drug substance release."
According to the news editors, the research concluded: "Application of this HILIC/MS method to the detailed characterization of a marketed therapeutic mAb, Rituxan ®, is described."
For more information on this research see: Development and Application of a Robust N-Glycan Profiling Method for Heightened Characterization of Monoclonal Antibodies and Related Glycoproteins. Journal of Pharmaceutical Sciences, 2014;103(7):1967-1978. Journal of Pharmaceutical Sciences can be contacted at: Wiley-Blackwell, 111 River St, Hoboken 07030-5774, NJ, USA. (Wiley-Blackwell - www.wiley.com/; Journal of Pharmaceutical Sciences - onlinelibrary.wiley.com/journal/10.1002/(ISSN)1520-6017)
Our news journalists report that additional information may be obtained by contacting T.Q. Shang, Pfizer Inc, Analyt R&D, Pearl River, NY 10965, United States. Additional authors for this research include A. Saati, K.N. Toler, J.M. Mo, H.Y. Li, T. Matlosz, X. Lin, J. Schenk, C.K. Ng, T. Duffy, T.J. Porter and J.C. Rouse (see also Immunology).
Keywords for this news article include: Pearl River, New York, United States, North and Central America, Blood Proteins, Glycoconjugates, Glycoproteins, Immunoglobulins, Immunology, Monoclonal Antibodies, Serum Globulins
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