OCT 10, 2017 07:00 AM PDT

WEBINAR: Achieving Higher Resolution Protein Impurity Analysis with Microfluidic CE

C.E. CREDITS: P.A.C.E. CE | Florida CE
  • Professor of Engineering, Professor of Chemical Engineering, Brown University
      Anubhav Tripathi leads a research group at Brown University that develops new pathogen diagnostic platforms by integrating biological and engineering principles. This work has a broad impact on scientists, engineers, physicians, and entrepreneurs. He holds many patents, has over 100 peer-reviewed publications, and delivered more than 50 invited talks. He is a Fellow of the American Institute of Medical and Biological Engineering. Prior to Brown, Tripathi led the development of microfluidics chips for protein and DNA sizing at Caliper LifeSciences (now PerkinElmer). This technology is sold in over one million chips a year.
    • Senior Application Scientist in the Applied Genomics Diagnostics Division at PerkinElmer
        Dr. James White is a Senior Application Scientist in the Applied Genomics Diagnostics Division at PerkinElmer. His research and development is focused on new product innovations for the PerkinElmer LabChip® Assay portfolio and affords new DNA and Protein microfluidic capillary electrophoresis applications. James' research experience spans chemistry, polymer chemistry, and biomedical engineering. Prior to joining PerkinElmer, James was a Postdoctoral Fellow at Tufts University where he applied his chemistry background towards the development and analytical characterization of neurological tissue scaffolds.


      DATE: October 10, 2017
      TIME: 7:00 AM PT, 10:00 AM ET

      Quality assessment of monoclonal antibodies can be a bottleneck in biopharmaceutical workflows because of the complexity and length of the workflows of conventional capillary electrophoresis (CE) systems. Microfluidic electrophoretic technology enables a simpler workflow with high resolution and sensitivity while offering time savings of 90%, completing analysis in 65 seconds per sample. Accelerating the speed of analysis in biotherapeutic workflows enables experimental determination of immense potential design spaces for both upstream and downstream development.

      Percent purity analysis becomes especially important in downstream applications, such as formulation, stability and manufacturing quality control (QC). At these later development stages, the ability to detect impurities is essential as quality assessment is critical to successful commercialization. Therefore, resolution and sensitivity must be sufficient to accurately detect contaminants in minute concentrations relative to the main peak. Results must also be reproducible with minimal variance from sample to sample and from run to run to instill confidence in purity analysis as proteins move through development and manufacturing QC into a commercialization environment.

      Here we demonstrate the utility of the LabChip® GXII Touch microfluidic system in applying microfluidic electrophoresis technology to protein impurity analysis using the Protein Clear™ HR Assay. This assay incorporates a percent purity reference standard with automated calibration and optimization software. Combining these technologies was shown to provide high degrees of resolution and reproducibility for sizing and percent purity of the light chain, heavy chain, and the non-glycosylated heavy chain peaks with relative standard deviations (RSDs) of 2% and 5% within and across runs.

      Learning Objectives:

      • Understand the role impurity analysis plays in biotherapeutic development
      • See how microfluidic capillary electrophoresis compares to other methods

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