CDMO: The Importance of Closed Systems in the Manufacturing Process

Cell-based therapies are growing in popularity and are in higher demand, creating a need for scalability in manufacturing. There are several challenges associated with the mass production of cell therapies, the most concerning of which being the safety and efficacy of the manufacturing process to ensure patients are receiving the highest-quality treatment. Utilizing automated, closed-loop systems, like the PXP®-SERIES, is the best way to decrease the risks associated with cell manufacturing, among other benefits.

Automated Closed Systems in the Cell Therapy Manufacturing Process

Traditional cell therapy manufacturing is conducted in a laboratory setting as an open system. While this methodology has served the biopharmaceutical industry well for many years, it has not been without its shortcomings. These include factors like greater time and labor costs and an increased risk of contamination due to exposure. Automated, closed-loop systems – those with equipment that is designed and operated in such a way that the product is not exposed to the room environment, are safer, more effective and more cost efficient.

Reduced Risk of Contamination

One of the greatest benefits of using a closed-loop system is the reduction in the risk of contamination through exposure. Closed systems provide a physical barrier to prevent contaminants from affecting the product. Open systems provide an opportunity for contamination simply through the process being open to the room environment and physically handled by operators. Avoiding contamination is important not only for safety reasons, but also because contamination can lead to costs associated with product loss and cleaning.

Reduced Process Time

Open cell manufacturing systems require experienced professionals to conduct the steps in the process. Closed systems, on the other hand, don’t rely as much on operator handling, and are thus less prone to human error. In addition, the full automation of the process eliminates extra steps, making the processing time faster.

Greater Cost Effectiveness

The cell therapy manufacturing process can be very costly. Cell and gene therapy companies need to ensure that they are fully evaluating the production process to ensure efficiency. While it’s relatively easy to define labor costs associated with production, overhead costs are often overlooked and/or difficult to calculate. With a reduced reliance on operator handling in a closed-loop system, less personnel is needed to oversee the process, which results in financial savings. The greater the savings during the manufacturing process, the more accessible life-saving treatments like CAR-T therapy are for the patients who need them.

CDMO and the Cell Therapy Manufacturing Process

ThermoGenesis Holdings Inc. is transforming cell therapy manufacturing with revolutionary technologies, like the PXP Systems and the X-BACS technology, which provide users with quick and effective tools for cell processing and manufacturing. 

A pioneer and market leader in the development and commercialization of cell processing technologies for the cell and gene therapy fields, ThermoGenesis Holdings Inc. markets a full suite of solutions for automated clinical biobanking. In addition, the company offers point-of-care applications and large scale cell processing and manufacturing, with a commitment to making the world a healthier place by creating innovative health solutions for everyone. Contact the team today for more information.