Overcoming common cell therapy manufacturing challenges with a closed, modular, and automated solution

While CAR T cell therapy approval by the FDA has moved quickly to the clinical setting over the last decade and a half (1), cell therapy manufacturing processes still lag in several areas.

For instance, some cell therapy manufacturers still use several open processes and manual handling, both of which can introduce contamination. Furthermore, cell therapy manufacturing is often a complex process that may use different products from different product providers. If there is a supply chain issue with a consumable or product crucial to the manufacturing process, then the drug could be stalled for months delaying the time for life-saving medicines to reach patients. Additionally, finding new products that are compatible, and which can be readily integrated into the existing workflow may present a challenge. This could cause an overhaul of the manufacturing process as replacement products may need to be optimized over several months to fit a company’s process.

Conversations we have had with collaborators also indicate the labor-intensive nature of cell therapy manufacturing which can make the process prone to errors.

Using a closed, modular, and automated solution

To overcome these challenges, we have created cell therapy manufacturing solutions that help manufacturers to operate within a closed, modular, and automated environment.

Thermo Fisher’s current cell therapy manufacturing workflow portfolio which includes the multipurpose Gibco Cell Therapy Systems (CTS^TM) Rotea^TM Counterflow Centrifugation System, the Gibco CTS^TM DynaCellect^TMMagnetic Separation System, and the Gibco CTS^TM Xenon^TM Electroporation System, present manufacturers with the opportunity to manufacture cell therapies from start to finish.

Our instruments may be used standalone or may be physically and digitally integrated into pre-existing workflows to create a seamless process that reduces manual handling while helping to ensure the final cell therapy product remains sterile.

Additionally, manufacturers can also source GMP-manufactured media, consumables, and reagents which are compatible with our instruments.

In the video below, we demonstrate using the CTS DynaCellect system, the CTS Rotea system, and the CTS Xenon system, as well as CTS^TM Dynabeads^TM technology to generate a T cell therapy product using a non-viral method of gene modification.

Learn more about our cell therapy manufacturing solutions here.

References

Sengsayadeth, S., Savani, B. N., Oluwole, O., & Dholaria, B. (2021). Overview of approved CAR-T therapies, ongoing clinical trials, and its impact on clinical practice. EJHaem, 3(Suppl 1), 6–10. https://doi.org/10.1002/jha2.338