Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene The views and opinions expressed during the Webinar are those of the presenter. Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release. Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level. Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

Hora

16:00 - 17:00 hs GMT+1

Organizador

BioPharma Asia Magazine
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Control de seguridad
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  • 5 Steps to Security Validation

    20:00 - 21:00 hs GMT+1

    Fecha
    Lun 15-Jun-2020, 20:00 - 21:00 hs GMT+1
    Descripción
    Organizations have been managing security based on assumptions, hopes and best guesses for decades. We assume our technology will detect, block and send alerts, we hope our incident response techniques will be efficient and effective when under assault, and we (...)
    Cerrar
Mar 16 de Junio de 2020
Mié 17 de Junio de 2020