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Improving Scalability of Gene-Modified Cell Therapy Manufacturing

Indee Labs microfluidic vortex shedding potential alternative to current gene-modified cell therapy manufacturing.

Indee Labs announced the publication of a proof-of-concept study demonstrating the efficacy of its gene-modified cell therapy (GMCT) development and manufacturing technology in Nature’s Scientific Reports.

The novel microfluidic method of intracellular delivery could provide a solution to one of the most significant challenges faced by the industry: scalability.

Unlike traditional medicines, GMCTs are made from patient and donor cells, which have been modified with the introduction of new genetic material.

Issues surrounding the most critical step in their manufacture, the delivery of new genes into cells, have held back both the pace of development of new treatments and scaled manufacturing of approved therapies such as CAR-T.

Most commonly this step is performed using engineered viruses; however, the GMCT market has been searching for non-viral alternatives due to supply challenges, costs, and other technical issues.

Indee Labs scientists managed successfully to deliver an mRNA construct into human T cells with high yield (i.e. transfection efficiency, cell viability, and cell recovery) and negligible perturbation to the T cell state, at a speed and scale that rivaled or exceeded conventional methods.

“Current in vitro and ex vivo intracellular delivery methods fail to meet the practical needs of GMCT development and manufacturing,” said Ryan S. Pawell, CEO of Indee Labs (USA). “Microfluidic vortex shedding (μVS) is already in development for a range of cell engineering methods outside of mRNA delivery to T cells.”

Other advantages of the μVS method include reduced costs, ease-to-scale, and substantially shorter lead times compared to clinical and commercial GMCT manufacturing using viruses.

This scalable gene-delivery technology for GMCT development and manufacturing does not damage immune cells and is an excellent alternative for discovery-stage research, clinical development, and commercial manufacturing of engineered or gene-modified human T cells.

They are working towards clinical development with multiple cell therapy clinics in both Australia and the United States.

The study was completed in collaboration with the University of Southern California Norris Comprehensive Cancer Center, the University of Sydney Medical School, and the University of South Australia Future Industries Institute. [APBN]