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The future of method development is in Analytical Quality by Design, but which tools do we need to get there?

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Join this free webinar to learn about AQbD flow and the benefits of using design of experiments software during chromatographic method development

28 Jun 2020
Diane Li
Assistant Editor

Expert insights

Dr Mark Eggink Byondis
Dr. Mark Eggink, Principle Scientist, Byondis

Analytical Quality by Design (AQbD) will start to play a more predominant role in the analytical field. Implementing AQbD in your workflows can have several advantages, for example it can make post-approval changes of an analytical method less complicated and time consuming. An AQbD flow is built-up of different parts, the most important being the Analytical Target Profile (ATP), which defines the requirements of the Critical Quality Attribute (CQA); from there an analytical technique can be selected. Furthermore, the use of a Design of Experiment (DoE) approach is increasing in popularity in analytical method development, as it enables fast and efficient development of robust methods.

In this SelectScience® webinar, Dr. Mark Eggink, Principle Scientist, Byondis, presents the analysis of an ATP, the AQbD flow, and the benefits of using DoE software in combination with separation software during method development of a size exclusion chromatography method for a mAb/ADC.

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Key learning objectives:

  • Analytical Quality by Design
  • Analytical Target Profile
  • Implementation of AQbD in biopharmaceutical development
  • Design of Experiments software for monoclonal and ADC assays

Who Should Attend?

  • Principal investigators
  • Consultants
  • R&D directors
  • Academia
  • Presenters

The live webinar takes place on Wednesday, July 15, 2020 at:

  • 16:00 BST
  • 17:00 CEST
  • 08:00 PDT
  • 11:00 EDT

Register to watch the full webinar here>>

SelectScience runs 3-4 webinars a month across various scientific topics, discover more of our upcoming webinars>>

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Tags

Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Software PlatformsSoftware platforms are useful for various stages of laboratory experiments from data collection to data storage and processing. For instance lab software is available for system control, data management, data analysis and qualification / validation.Chromatography Method DevelopmentChromatography method development is the process of designing and optimizing chromatographic techniques to separate and analyze complex mixtures. This includes selecting appropriate stationary and mobile phases, determining flow rates, and optimizing detection methods. Successful method development is essential for high-quality results in fields like pharmaceuticals, food safety, and environmental analysis. Explore chromatography method development tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.ATP MonitoringChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.SECSize exclusion chromatography (SEC) separates molecules based on size, ideal for protein purification, polymer analysis, and biopharma applications. SEC ensures precise characterization of biomolecules for research and industry. Explore peer-reviewed SEC products and compare options for your lab.

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The future of method development is in Analytical Quality by Design, but which tools do we need to get there?