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CASSS Welcome & CGTP Summit 2023 Introduction
Date
June 26, 2023
This product is not available for individual purchase, but it is available as part of the following products:
The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…
Comparability assessments are necessary for life cycle management of all biological products, including cell and gene therapies (CGT), and are conducted to ensure that manufacturing changes do not adversely impact product quality, safety, or efficacy. The complexity and diversity of CGT product modalities can pose considerable challenges to the usual approaches, which are guided by the principles in ICH Q5E. In this summit, we will discuss a range of CGT modalities and some new concepts in comparability required for certain CGT products.
Session Chair
General
Tracks
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