Potency Assays for ATMPs — Conception, Development, Validation, Matrixed Approaches and Assay Lifecycle, Upcoming Webinar Hosted by Xtalks

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In this free webinar, learn about considerations in developing potency assays for advanced therapy medicinal products (ATMPs) vs mechanism of action and regulatory guidance. The attendees will learn about the technologies to employ and data processing and acceptance criteria consideration. The featured speaker will discuss matrixed approaches and phase-appropriate lifecycle considerations.

The control strategies are very different from more traditional biologics, with quantitation of potency posing one of the greatest challenges.

Advanced therapy medicinal products or ATMPs, are among the fastest growing areas of biotherapeutics, encompassing gene therapies, viral therapies, vaccines and cell therapies. The control strategies are very different from more traditional biologics, with quantitation of potency posing one of the greatest challenges. In this webinar, representative case studies will demonstrate considerations in the conception, development and validation of potency assays — mostly cell-based — for representative ATMPs. The use of different analytical technologies and complex assay schema will be provided along with consideration of timing, phase-appropriate validation (qualification) considerations and assay lifecycle guidance as the product moves through the clinical development phases.

Topics for discussion will include data and statistical considerations and how data may be processed to extract relevant insights and monitor attributes such as relative potency. The implications of global regulatory guidance and precedence will also be discussed.

Register to learn about the conception, development, validation, matrixed approaches and assay lifecycle of potency assays.

Join Jeff Patrick, PhD, Senior Director of GMP Operations, BioAgilytix, and Lynn Kamen, PhD, Scientific Officer and Executive Director, BioAgilytix for the live webinar on Thursday, November 17, 2022, at 10am EST (4pm CET/EU-Central).

For more information, or to register for this event, visit Potency Assays for ATMPs — Conception, Development, Validation, Matrixed Approaches and Assay Lifecycle.

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/

Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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Vera Kovacevic
Xtalks
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