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.
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The development of advanced therapy medicinal products is dogged by a lack of regulation and guidance and differences in what should and should not be deemed an ATMP, according to speakers at last month’s pre-ICDRA gathering of world regulators.
Building manufacturing capacity, educating physicians, and reaching agreements with pricing and reimbursement bodies are just some of the hurdles CAR-T therapies have to jump over in Europe, following their approval by the EU Commission earlier this week.
FDA says manufacturers need robust shipping programs to ensure the safety and quality of cell therapies, since there are no ready replacements and a patient’s life can be at risk if problems arise. Kite exec notes that “more than any other biologic, the supply chain of autologous cell therapies reaches really literally end-to-end.”