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W103e - A Patient-centric Control Strategy for a Cell and Gene Therapy Product

‐ May 13, 2020 3:55pm

A case study will be presented focusing an autologous T Cell product in late stage development. To maximize patient access to safe and effective quality product, the variance that is contributed by patient heterogeneity and product knowledge of the quality attribute-clinical outcome relationship must be considered to establish a patient-centric specification


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