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The OPALCAR Common Technical Document outlines the quality specifications for the autologous anti-CD19 CAR T-cell drug substance produced by Opal Bio Pharma. It includes detailed sections on general information, manufacturing processes, characterization, control measures, reference standards, container closure systems, and stability. The document emphasizes the use of a third-generation self-inactivating lentiviral vector for CAR transduction, ensuring stable expression and minimizing replication-competent

Author

mjavanopal

Language

EN