Research Data from Boehringer Ingelheim Pharma Update Understanding of Immunoglobulins (Microchip Zone Electrophoresis for High-Throughput Analysis...

Life Science Weekly |

Research Data from Boehringer Ingelheim Pharma Update Understanding of Immunoglobulins (Microchip Zone Electrophoresis for High-Throughput Analysis of Monoclonal Antibody Charge Variants) By a News Reporter-Staff News Editor at Life Science Weekly -- Current study results on Immunology have been published. According to news reporting originating from Biberach, Germany, by NewsRx correspondents, research stated, "A high-throughput screening assay on a microfluidic chip was developed for the determination of charge variants of monocolonal antibodies (mAbs) in pI range of 7-10. This method utilizes microchip zone electrophoresis for rapid separation (<90 s) of mAb charge variants that are labeled fluorescently without altering the overall charge." Our news editors obtained a quote from the research from Boehringer Ingelheim Pharma, "The microfluidic assay achieves between 8- and 90-fold times faster separation time over conventional methods while maintaining comparable resolution and profiles of charge variant distributions. We further characterized the assay with respect to (i) the effect of pH on resolution, (ii) the effect of excipients and buffering agents, (iii) the performance of the assay compared to conventional methods, and (vi) the reproducibility of charge variant profiles. Finally, we explored the utility of the assay with four case studies: (i) monitoring C-terminal lysine modification of a mAb, (ii) quantifying the extent of deamidation of a mAb, (iii) providing charge variant information on which to base clone selection, and (iv) making process parameter-related decisions from a 'design of experiment' (DoE) study." According to the news editors, the research concluded: "The results of these case studies demonstrate the applicability of the microfluidic assay for high-throughput monitoring of mAb quality in process development of biopharmaceuticals." For more information on this research see: Microchip Zone Electrophoresis for High-Throughput Analysis of Monoclonal Antibody Charge Variants. Analytical Chemistry, 2014;86(11):5416-5424. Analytical Chemistry can be contacted at: Amer Chemical Soc, 1155 16TH St, NW, Washington, DC 20036, USA. (American Chemical Society -; Analytical Chemistry - The news editors report that additional information may be obtained by contacting T.D. Wheeler, Boehringer Ingelheim Pharma GmbH & Co KG, Dept. of Proc Sci, D-88397 Biberach, Germany. Additional authors for this research include J.L. Sun, S. Pleiner, H. Geier, P. Dobberthien, J. Studts, R. Singh and B. Fathollahi (see also Immunology). Keywords for this news article include: Antibodies, Europe, Germany, Biberach, Immunology, Blood Proteins, Immunoglobulins Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC

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