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Production of Human CRISPR-Engineered CAR-T Cells
Published on: March 15, 2021
Process Systems Engineering in Precision Medicine: Opportunities in Autologous CAR-T Therapy
1Department of Chemical and Biological Engineering Rensselaer Polytechnic Institute Troy New York USA.
Abstract:
Autologous chimeric antigen receptor (CAR)-T therapies have given hope to many cancer patients whose other lines of treatment have failed. Unfortunately, limited manufacturing capability has resulted in many patients dying while on a waitlist. Similarly, since clinical trial treatments are personalized, it is difficult to treat many patients simultaneously, resulting in longer clinical trials. Therapeutic production often takes over 4 weeks, so a product failure means that a patient may need to wait another month for treatment, putting them at severe risk for disease progression. The labor-intensive manufacturing process has led to therapeutic costs of roughly $500,000 per treatment, which can be reduced by better automation and shorter manufacturing times. The goals of this article are to review CAR-T therapeutics development, manufacturing, and treatment, and to encourage the development of data analytics-based multi-scale decision support tools for all humans "in the loop." A systems approach is needed since prior treatments and current state of health (including the immune system and microbiota), initial cell quality, manufacturing failure, bridging and lymphodepletion therapy before infusion, and supply chain management, all impact treatment success. Continuous updates as more patient data are made available can lead to better treatment recommendations and outcomes.
Insights
Limited manufacturing capacity for chimeric antigen receptor (CAR)-T cell therapies causes patient waitlists and high costs. Developing data analytics tools can improve CAR-T therapy manufacturing, reduce costs, and enhance patient outcomes.
Area of Science:
- Oncology
- Immunotherapy
- Biotechnology
Background:
- Autologous chimeric antigen receptor (CAR)-T cell therapies offer a vital treatment option for refractory cancers.
- Current manufacturing limitations lead to significant patient wait times and high costs.
- Personalized nature of CAR-T treatments complicates simultaneous patient treatment and extends clinical trials.
Purpose of the Study:
- To review the development, manufacturing, and treatment of CAR-T therapeutics.
- To advocate for data analytics-based decision support tools to optimize CAR-T therapy.
- To highlight the need for a systems approach in CAR-T therapy to improve patient outcomes.
Main Methods:
- Review of existing literature on CAR-T therapy development and manufacturing.
- Analysis of factors impacting CAR-T treatment success, including patient health, cell quality, and supply chain.
- Proposal for integrating data analytics and decision support tools into the CAR-T workflow.
Main Results:
- Manufacturing delays and failures pose significant risks to patients awaiting CAR-T therapy.
- Current manufacturing processes are labor-intensive, contributing to high treatment costs (approx. $500,000 per dose).
- A systems-level perspective is crucial, considering pre-treatment factors, manufacturing, and supply chain logistics.
Conclusions:
- Enhanced automation and reduced manufacturing times are critical for increasing CAR-T therapy accessibility.
- Data analytics and multi-scale decision support tools can streamline manufacturing and improve treatment efficacy.
- Continuous data updates can refine treatment recommendations and improve patient outcomes in CAR-T therapy.
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