OCT 28, 2014 7:00 AM PDT

Quality-by-Design Development of a Purity Method Using ACQUITY UPLC H-Class and QDa Mass Detector

Speaker
  • Founders and Managing Directors, Chromicent GmbH
    Biography
      Alexander H. Schmidt has worked 25 years as head of quality control as well as laboratory manager of a development laboratory in a medium-sized, global pharmaceutical company. His expertise lies in the development and validation of analytical methods according to the latest quality-by-design approaches, the qualification of analytical instrument (AIQ), increased efficiency in the laboratory as well as GMP and compliance. Alexander H. Schmidt is the author of more than 50 publications and scientific posters and also a guest lecturer at the Beuth University in Berlin.
       
      Mijo Stanic has worked closely for several years as head of analytical development with Alexander Schmidt. He is an expert in quality-by-design in the development of chromatographic separation methods and mass spectrometry. He is also co-author of numerous publications.

    Abstract

    Pre-recorded webinar available for immediate playback.

    Traditional method development, in which an LC method is developed principally by trial-and-error, is time consuming and may not result in a robust method. In addition, taking this approach provides no understanding of the influence of key factors on the results. Conversely, modern systematic method development strategies using statistical or modeling software tools to generate experimental designs and explore method robustness offer numerous advantages and can provide a fast and efficient approach for method development.

    Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The aim of their recent work has been to apply quality-by-design principles to build in a more scientific and risk-based, multifactorial strategy in the development of a new UHPLC methods. In this webinar, they will describe the application of their approach in the development of a new purity method for a well known API. The final method, with an analysis time of only 4 minutes, provides a 40-fold increase in productivity compared to the existing method published in the European Pharmacopeia.


    Show Resources
    You May Also Like
    JUN 09, 2020 10:00 AM PDT
    C.E. CREDITS
    JUN 09, 2020 10:00 AM PDT
    DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
    JUN 23, 2020 10:00 AM PDT
    C.E. CREDITS
    JUN 23, 2020 10:00 AM PDT
    DATE: June 23, 2020 TIME: 10:00am PT Human mesenchymal stromal or stem cells (MSCs)-based immunomodulation treatment has been proposed as a suitable therapeutic approach for many diseases, s...
    AUG 27, 2020 7:00 AM PDT
    C.E. CREDITS
    AUG 27, 2020 7:00 AM PDT
    DATE: August 27, 2020 TIME: 7:00am PT Novel anti-viral medications, including biologics and small molecule inhibitors, as well as serologic diagnostic tool sets are in urgent demand to fight...
    OCT 08, 2020 7:00 AM PDT
    C.E. CREDITS
    OCT 08, 2020 7:00 AM PDT
    DATE: October 8, 2020 TIME: 7:00am PDT, 10:00am EDT, 4:00pm CEST How often do you pipette in your cell culture lab every day? Usually, we do it so often that we tend stop thinking about ho...
    DEC 02, 2020 8:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    DEC 02, 2020 8:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: December 2nd, 2020 TIME: 08:00am PDT, 11:00pm EDT Bioreactors and shakers are used to cultivate microorganisms, plant, insect, and mammalian cells in different volumes. Upscaling of pr...
    AUG 25, 2020 8:00 AM PDT
    C.E. CREDITS
    AUG 25, 2020 8:00 AM PDT
    DATE: August 25, 2020 TIME: 8:00am PDT, 10:00am CDT, 11:00am EDT Recombinant lentivirus (LV) and adeno-associated virus (AAV) are critical components of cell and gene therapies, which show g...
    Loading Comments...
    Show Resources
    Attendees
    • See more