A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies
Abstract
Background aims Autologous cell therapy (AuCT) is an emerging therapeutic treatment that is undergoing transformation from laboratory- to industry-scale manufacturing with recent regulatory approvals. Various challenges facing the complex AuCT manufacturing and supply chain process hinder the scale out and broader application of this highly potent treatment. Methods We present a multiscale logistics simulation framework, AuCT-Sim, that integrates novel supply chain system modeling algorithms, methods, and tools. AuCT-Sim includes a single facility model and a system-wide network model. Unique challenges of the AuCT industry are analyzed and addressed in AuCT-Sim. Decision-supporting tools can be developed based on this framework to explore "what-if" manufacturing and supply chain scenarios of importance to various cell therapy stakeholder groups. Results Two case studies demonstrate the decision-supporting capability of AuCT-Sim where one investigates the optimal reagent base stocking level, and the other one simulates a reagent supply disruption event. These case studies serve as guidelines for designing computational experiments with AuCT-Sim to solve specific problems in AuCT manufacturing and supply chain. Discussion This simulation framework will be useful in understanding the impact of possible manufacturing and supply chain strategies, policies, regulations, and standards informing strategies to increase patient access to AuCT.
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Applying CRISPR/Cas with non-viral delivery of template DNA to eliminate large genes or for orthotopic placement of transgenic constructs could reduce the potential of off-target effects.
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- Authors
- Wang, K., Liu, Y., Li, J., Wang, B., Bishop, R., White, C., Das, A., Levine, A. D., Ho, L., Levine, B. L., & Fesnak, A. D.
- Affiliations
- Georgia Institute of Technology (US)
- Morgridge Institute for Research (US)
- Abramson Cancer Center (US)
- University of Pennsylvania (US)
- Corresponding author
- Wang, Kan
- ORCID
- Venue
- Cytotherapy
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 21
- Issue
- 10
- Pages
- 1081-1093
- ISSN
- 1465-3249 (ISSN-L)
- OpenAlex
- W2969560745
- Cited by
- 29
- References
- 18
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 4 · 2023: 4 · 2022: 8 · 2021: 4 · 2020: 3
- FWCI
- 2.69
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Cytotherapy (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Science Foundation
- Topics
- Social Sciences › Decision Sciences › Management Science and Operations Research › Simulation Techniques and Applications
- Social Sciences › Business, Management and Accounting › Management Information Systems › Supply Chain and Inventory Management
- Social Sciences › Business, Management and Accounting › Strategy and Management › Supply Chain Resilience and Risk Management
- Keywords
- autologous cell therapy, cell therapy manufacturing, supply chain management, logistics simulation, multiscale modeling, network models, decision support, patient access
- MeSH terms
- Manufacturing and Industrial Facilities, Equipment and Supplies Utilization, Algorithms, Commerce, Computer Simulation, Drug Industry, Humans, Manufactured Materials, Quality Control, Transplantation, Autologous, United States, Quality Indicators, Health Care, Cell- and Tissue-Based Therapy
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