Impact of Deviation Closure Timelines on Cell Therapy Supply Chain Performance and the Role of Technology in Accelerating Resolution

Authors: Ashish Patil

DOI: https://doi.org/10.37082/IJIRMPS.v13.i4.232653

Short DOI: https://doi.org/g9t99w

Country: United States

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Abstract: Cell therapy is transforming personalized medicine by enabling the use of patient-derived cells to treat complex and previously incurable diseases. However, the supply chain underpinning cell therapy is uniquely sensitive, requiring strict control of time, temperature, identity, and traceability. Within this context, deviations—any departures from approved protocols—present serious risks. When deviation closures are delayed, the resulting quality holds, patient rescheduling, and cold chain storage issues introduce inefficiencies and escalate costs. This paper explores the structural impact of deviation closure timelines on end-to-end cell therapy supply chains and proposes a technology-driven solution to accelerate resolution. Through integration of artificial intelligence, IoT-based monitoring, and digital quality systems, deviation closure durations can be reduced from 30–45 days to under 10 days. This shift not only enhances regulatory compliance but also compresses supply chain lead time, enabling faster patient access, lower holding costs, and improved production scalability.

Keywords: Cell Therapy, Deviation Management, GMP, CAPA, Supply Chain Lead Time Optimization, AI in Quality Systems, Pharmaceutical Logistics, Quality Assurance, Digital Transformation

Paper Id: 232653

Published On: 2025-07-25

Published In: Volume 13, Issue 4, July-August 2025

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