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Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
Session Chair(s)
Fouad Atouf, PhD
Senior Vice President, Global Biologics
US Pharmacopeia (USP), United States
This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.
Learning Objective : Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.
Speaker(s)
Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD
Cellx Inc., Consulting, United States
Chief Regulatory Scientist
Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD
FDA, United States
Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER
Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD
VCLS, United States
Senior Director, Regulatory Science
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