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2026-04-07|

Leukapheresis Bottlenecks Threaten Scalability of Cell and Gene Therapies Amid Rising Demand

by GOAI
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Leukapheresis is becoming a pivotal challenge in the supply chain for both autologous and allogeneic cell therapies, according to industry experts. As demand for cell and gene therapies (CGTs) continues to grow, securing a reliable leukapheresis process has emerged as a critical issue that could impact the scalability and accessibility of these treatments.

Leukapheresis, a procedure used to collect white blood cells from patients or donors, serves as the foundational step in many CGT manufacturing processes. Experts have identified several factors contributing to this bottleneck. These include limited availability of specialized equipment, trained personnel shortages, and logistical complexities associated with transporting collected cells under strict temperature-controlled conditions. Additionally, variability in donor health and collection yields further complicates efforts to standardize the process across different therapy platforms. Industry stakeholders are increasingly focused on addressing these challenges to ensure uninterrupted production pipelines for life-saving therapies.

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Date: April 7, 2026

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