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Gene Therapy

Gene Therapy

Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...

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Related Experiment Video

Updated: Sep 10, 2025

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

Digital Model-Driven Cell & Gene Therapy Process Development.

Evan Claes^1,2, Tommy Heck¹, Roger Dalmau-Diaz³

¹Antleron NV, Leuven, Belgium.

Biotechnology and Bioengineering

|August 27, 2025

Summary

This summary is machine-generated.

Digital models optimize cell and gene therapy manufacturing, reducing costs and development time. This AI-driven approach enhances productivity and sustainability for large-scale patient treatment.

Keywords:

bioreactors cell & gene therapy digital model multi‐objective process development process optimization

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Last Updated: Sep 10, 2025

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

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Published on: August 18, 2023

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Published on: October 6, 2023

Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow

Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow

Published on: March 17, 2023

Area of Science:

Biotechnology
Process Engineering
Regenerative Medicine

Background:

Cell and gene therapy manufacturing requires process intensification for industrial translation and cost-effective patient access.
Current optimization methods are time-consuming and resource-intensive, hindering scalability.
Regulatory bodies like the FDA encourage advanced manufacturing approaches.

Purpose of the Study:

To develop and apply a digital model-driven framework for multi-objective optimization of cell and gene therapy manufacturing processes.
To optimize the expansion of human mesenchymal stem cells in a fixed-bed bioreactor.
To balance productivity, cost-efficiency, and throughput in process development.

Main Methods:

Integrated a hybrid cell growth model with a cost-of-goods model.
Conducted 20,000 in silico experiments to optimize culture time and feeding strategies.
Validated optimized processes experimentally.

Main Results:

Achieved up to 38% improvement in cost efficiency, yield, and throughput compared to a benchmark.
Reduced process development costs by 57% and time by 81%.
Demonstrated the feasibility of digital models for sustainable, multi-objective process development.

Conclusions:

Digital model-driven optimization is a valuable tool for cell and gene therapy process development.
This approach addresses critical manufacturing needs and aligns with regulatory trends favoring AI.
The framework enables efficient, cost-effective, and scalable production of cell and gene therapies.