Potency Assay Development – Turning an R&D Assay into a GMP QC Assay, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speaker will explain what a relative potency assay is and why it is important, as well as factors to consider when developing and optimising a potency method. Attendees will learn what appropriate system and sample suitability criteria are and how to set them.

Xtalks Life Science Webinars

In this webinar, the presenter will focus on the cell-based potency assay, the principles of which also apply to ligand-binding assays (ELISA).

Potency is an important critical quality attribute of any large molecule drug product and a precise and accurate assay is required for the release of drug product under Good Manufacturing Practice (GMP). Potency assays are technically difficult to develop and transfer but are also an essential part of the analytical strategy in any drug development pathway.

The potency assay is used to measure the ability of a drug to elicit a particular response at a certain dose in a relevant biological system and should ideally reflect the known mechanism of action of the drug and that it is related to the expected clinical response.

Developing a suitable potency assay is fraught with challenges and so a well thought-out plan and an understanding of what is important at each stage can help enormously.
In this webinar, the presenter will focus on the cell-based potency assay, the principles of which also apply to ligand-binding assays (ELISA).

Specifically, the webinar will cover:

  • An introduction to relative potency assays including regulatory requirements, why a dose range is used and how to assess similarity to a reference standard.
  • Specific considerations for development and optimisation of the assay for GMP environment.
  • Strategies used to evaluate the performance of the potency assay prior to the validation phase including useful tips on monitoring the performance of the assay and what to track once the assay is developed.

Join Emma Bowen, PhD, Senior Assay Development Scientist, Covance in a live webinar on Tuesday, June 30, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Potency Assay Development – Turning an R&D Assay into a GMP QC Assay.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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