The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing. Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia  Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

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Julio / 2020 119 webinars
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  • Devops. Ese gran desconocido

    15:30 - 16:30 hs GMT+1

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    Mar 30-Jul-2020, 15:30 - 16:30 hs GMT+1
    Descripción
    Desarrolladores y Técnicos de las áreas de Administración de Sistemas y Operaciones tienen una relación compleja en la que, en muchas ocasiones, genera una lucha sobre quién domina a quien o sobre quién debe liderar y protagonizar el ciclo de (...)
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  • Metrics that Matter: Balanced Scorecard

    20:00 - 21:00 hs GMT+1

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    Mar 30-Jul-2020, 20:00 - 21:00 hs GMT+1
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    Despite all the data that support managers have at their fingertips, most cannot answer a very basic question: How is my support organization performing? MetricNet’s research shows that establishing a single, overall performance metric for your support organization is critical. (...)
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  • Devops. Ese gran desconocido

    15:30 - 16:30 hs GMT+1

    Fecha
    Jue 30-Jul-2020, 15:30 - 16:30 hs GMT+1
    Descripción
    Desarrolladores y Técnicos de las áreas de Administración de Sistemas y Operaciones tienen una relación compleja en la que, en muchas ocasiones, genera una lucha sobre quién domina a quien o sobre quién debe liderar y protagonizar el ciclo de (...)
    Cerrar
  • Metrics that Matter: Balanced Scorecard

    20:00 - 21:00 hs GMT+1

    Fecha
    Jue 30-Jul-2020, 20:00 - 21:00 hs GMT+1
    Descripción
    Despite all the data that support managers have at their fingertips, most cannot answer a very basic question: How is my support organization performing? MetricNet’s research shows that establishing a single, overall performance metric for your support organization is critical. (...)
    Cerrar
Vie 31 de Julio de 2020
Sáb 01 de Julio de 2020
Dom 02 de Julio de 2020

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