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Updated: Feb 24, 2026

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

Bioengineering Solutions for Manufacturing Challenges in CAR T Cells.

Nicole J Piscopo^1,2, Katherine P Mueller^1,2, Amritava Das^1,2

¹Department of Biomedical Engineering, University of Wisconsin, Madison, WI, USA.

Biotechnology Journal

|August 26, 2017

Summary

Chimeric antigen receptor (CAR) T cell therapies are powerful "living drugs" for cancer treatment. Bioengineering innovations are crucial for overcoming manufacturing challenges and enabling wider clinical adoption.

Keywords:

CAR T cells bioengineering biomaterials bioprocess engineering cancer cellular engineering cellular therapy genetic engineering medical biotechnology metabolic engineering

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Manufacturing Chimeric Antigen Receptor CAR T Cells for Adoptive Immunotherapy

Manufacturing Chimeric Antigen Receptor CAR T Cells for Adoptive Immunotherapy

Published on: December 17, 2019

Area of Science:

Cellular therapy
Immunotherapy
Bioengineering

Background:

Cell therapies, or
living drugs
represent the next wave of clinical therapeutics due to their dynamic response capabilities.
Genetically engineered chimeric antigen receptor (CAR) T cells are potent tools for cancer immunotherapy, showing significant efficacy in hematological malignancies.
Despite clinical successes, the complex engineering and manufacturing of CAR T cells hinder widespread adoption.

Purpose of the Study:

To describe the manufacturing process of CAR T cells.
To highlight the role of bioengineering in advancing CAR T cell production.
To emphasize the collaboration between bioengineers, biologists, and clinicians for rigorous quality control.

Main Methods:

Review of current CAR T cell manufacturing processes.
Identification of bioengineering approaches (biomaterials, synthetic biology, metabolic engineering, process control, automation, in vitro modeling) to address manufacturing challenges.
Discussion of regulatory and quality control aspects in cellular product manufacturing.

Main Results:

CAR T cell therapy is a rapidly developing field with increasing regulatory approvals.
Significant challenges exist in the scalable and consistent manufacturing of CAR T cells.
Bioengineering offers potential solutions to optimize CAR T cell production and quality.

Conclusions:

Advancing CAR T cell therapy requires overcoming manufacturing hurdles.
Bioengineering expertise is essential for developing robust and scalable manufacturing processes.
Multidisciplinary collaboration is key to ensuring the quality and accessibility of these complex cellular therapies.