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Comparability for Cell and Gene Therapy Products | CGTP Summit 2023 White Paper

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Originally Published in BioProcess International 
CGTP Summit 2023 White Paper
Comparability for Cell and Gene Therapy Products
K.R. Poudel, Zenobia Taraporewala, Diane Blumenthal, Deep Shah, and Kathy Francissen

Cell and gene therapies (CGTs) are the fastest growing segment of biotechnology products, with chimeric antigen receptor (CAR) T-cell products and gene therapies using adenoassociated virus (AAV) vectors dominating the landscape. To meet the increasing demands of these promising therapeutics, manufacturing changes often are implemented during clinical development as sponsors scale production up or out and optimize processes for productivity and performance. A well-designed comparability study is critical for demonstrating an absence of adverse effects on product quality, safety, and efficacy when a manufacturing change is made. The complexity of CGT product modalities and their current level of characterization pose challenges to the approaches typically used for assessing comparability, as guided by the principles described in ICH Q5E.