Cell And Gene Therapy Logistics Requires Early Planning

It has become standard practice for manufacturing to get early attention in the cell and gene therapy development, but logistics is often not considered until closer to commercialization, which could be a strategic mistake given the speed with which new treatments are being approved.

Delivering a cell therapy in a Phase I, single academic center clinical trial is not difficult when it is a matter of walking reengineered cells across campus from the lab to the hospital, but the real-world setting is a much bigger challenge. With accelerated approvals moving these novel treatments from early human studies to commercialization in short order, it is important to think about logistics early in the development process.

During the Cell and Gene Meeting on the Mesa hosted by the Alliance for Regenerative Medicine (ARM), Oct. 3-5 in...

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