In order to understand cancer, one needs to first understand a bit about how cancer starts, and that involves our cells. Cancer cells have been the focus of research for our partner Miltenyi Biotec since 1989. Today we are talking with Martha Elia Luevano Salinas, an expert for CAR-T cell engineering and application, on the latest developments in cancer research at Miltenyi.
Since Miltenyi Biotec’s foundation in 1989, it has been the company’s mission to provide researchers and clinicians around the world with innovative solutions to help them find better ways to understand and ultimately treat cancer. We design, develop, manufacture, and integrate products that empower the advancement of biomedical research and enable cell and gene therapy. This includes tools, instrumentation, reagents, and CDMO services.
That is correct. We launched the platform in 2012, and the T cell Transduction (TCT) process has been available since 2016. It has been central to numerous clinical trials around the world since that time, and we are always innovating to expand its possibilities. For example, we are presently introducing capabilities for automated sampling, product formulation, and transfection of cells.
CAR T cell manufacturing starts with the extraction of a patient’s own T cells, which is why you cannot produce them in stock, as is conventionally done in pharma. The process is time-consuming (approx. two weeks) and contains multiple complex cell processing steps. It is intense work, requiring expertly trained specialist personnel who conduct these steps in tightly controlled, expensive cleanrooms. These laboratories, along with the instruments and raw materials, have to be highly regulated to ensure a safe product for each individual patient.
The CliniMACS Prodigy automates and standardizes multiple complex cell processing steps, reducing hands-on time. Since it is a closed system, it provides a safe and sterile environment for sensitive cells. It allows for parallel manufacturing and easy scale-up of manufacturing, as each CliniMACS Prodigy can run one patient product at a time. Since the device is only the size of an office printer, many instruments can be run simultaneously in the same cleanroom. We have an example of this kind of setup in our own CliniMACS Cell Factory™. It is a very flexible platform, capable of manufacturing several other cell products, including HSCs, NK, T-regs or DCs, and it can be used for development as well as clinical manufacturing.
Automation enables more products to be manufactured in the same room, allowing more patient treatments to be produced simultaneously. Time is of the essence for these patients, which is why we continue to research ways to further shorten the process so they can receive their treatments faster.
The challenges that come from centralised manufacturing include limited accessibility and logistical hurdles. Nevertheless, the cell therapy field is growing at a tremendous rate. In the future, cell manufacturing will improve accessibility to treatment by enabling point-of-care treatment (decentralized manufacturing). It will offer higher safety due to new technological developments, and we will create more effective cell therapies by combining innovative gene-editing tools. In short, new innovations will allow personalized medicine to be safer, more accessible, and more efficient in treating cancer.
Cancer is a devastating set of diseases that touch many people’s lives. Everyone at Miltenyi Biotec is committed to our company mission to “Make Cancer History”. We are proud of our technologies and services that help scientists, clinicians, and patients worldwide to make progress in their fight against severe diseases such as cancer.