Manufacturing cell and gene therapies is complex due to their living nature and the need for precision at every step.
ARM is at the forefront of working with experts to develop timely resources and workshops to address challenges to cell and gene therapy manufacturing and CMC programs.
One of ARM’s leading resources that explores how to apply Quality by Design (QbD) principles in cell therapy CMC program development.
One of ARM’s leading resources that explores how to apply Quality by Design (QbD) principles in gene therapy CMC program development.
ARM hosts dynamic workshops on cell and gene therapy manufacturing and other topics to review current industry best practices.
ARM hosts Scientific Exchanges with the FDA to tackle pressing regulatory issues, including CMC. Learn more about ARM’s regulatory engagement.
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