CGTP Summit / Cell and Gene Therapy Products Symposium 2023:
CGTP Summit
June 26, 2023
Comparability assessments are conducted to ensure that manufacturing changes do not adversely affect the product in terms of quality, safety, or efficacy. Demonstration of product comparability is generally based on a combination of analytical testing and biological assays at the product release and characterization levels, as well as at the process performance level, and can involve nonclinical and/or clinical data. The extent of a comparability assessment also depends on the phase of product development. The overarching principles for evaluating comparability of biological products are described in ICH Q5E and, while these principles are generally applicable to cell and gene therapies, there are unique challenges posed by this diverse and complex class of medicinal products. In this summit, we will discuss comparability strategies that address the unique challenges posed by cell and gene therapy products. Examples for viral vector-based gene therapies and cellular therapies will be presented.
CGTP Symposium
June 27 - 29, 2023
The CASSS Cell and Gene Therapy Products 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. The 2023 Symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed.
CGTP Summit / Cell and Gene Therapy Products Symposium 2023 Program Partners
The scientific organizing committees gratefully acknowledge the following program partners for their generous support of the CGTP Summit / Cell and Gene Therapy Products Symposium 2023.
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CGTP Symposium 2023 Exhibitors
The scientific organizing committee gratefully acknowledges the following exhibitors for their generous support of the CGTP Symposium 2023.
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