An estimated 19.3 million new cancer cases are diagnosed every year. This number is expected to grow to 28.4 million by 2040. Cell therapy, a treatment that uses a patient’s own cells to fight disease, offers hope by improving the immune system’s ability to defeat cancer.
Chimeric antigen receptor (CAR) T-cell therapy helps T cells, a type of white blood cells made by the immune system, fight cancer better. CAR-T cell therapy is already being used to treat lymphomas, leukemias, and multiple myeloma. But manufacturing cell therapies like CAR-T cell therapy is difficult and limited, creating a bottleneck for getting these breakthrough treatments to all eligible patients.
Cellares, a life sciences technology company, is working to make cell therapy widely available and affordable. The company recently announced its partnership with Poseida Therapeutics to accelerate cell therapy manufacturing. By joining Cellares’ Early Access Partnership Program (EAPP), Poseida Therapeutics will get access to the Cellares Cell Shuttle, a cell therapy manufacturing platform that is closed, automated, and scalable.
Why Are Cell Therapies So Difficult to Manufacture?
The pharmaceutical industry is struggling to meet patient demand for life-saving therapeutics like cell therapy. Some of the biggest challenges that cell therapy faces today are how to make it affordable and scalable, so more patients can access the treatments.
According to Cellares, all of the commercially produced cell therapy added up to 3,000 to 4,000 patient doses last year. However, the patient population that needed CAR-T cells was 450,000 patients and is expected to exceed 2 million patients within five to 10 years.
“The big hurdle to access is they cannot make enough cell therapy doses as an industry,” says Fabian Gerlinghaus, co-founder and CEO of Cellares. “There is a lack of automated, high-throughput manufacturing technologies.”
What makes cell therapy unique is it requires making therapeutics for one patient at a time. For example, one batch of cell therapy may only be enough for 50 patients. On the other hand, small molecules or biologics can be made through complex manufacturing processes that create a batch of drug products for 50,000 patients or more.
Cell therapy is personalized medicine that is made to order and requires a patient’s or donor’s cells as the starting material. Teams of highly trained scientists spend two to three weeks in expensive cleanrooms manually going through the steps to make therapeutics with benchtop instruments. The entire process can take 80 hours for one batch.
“None of the benchtop instruments most research teams use today were ever designed for cellular manufacturing. So it is a very labor-intensive process that generates 500 pages of records for each patient. Essentially, they are writing a book for every dose,” says Gerlinghaus.
All of the manual manufacturing steps create the risk of operator error. For example, 50 manual operating steps for 10,000 patient doses of cell therapy create 50,000 opportunities for operator errors. Using benchtop instruments that are not part of a closed system also creates the risk of contamination.
“Operator error and contamination are the two biggest sources of process failure, and process failure can lead to the loss of a patient’s life. This is a big risk in cell therapy because you are making these drugs for cancer patients who are terminally ill and already vulnerable,” says Gerlinghaus.
A two-week manufacturing process with a large amount of manual labor cannot be scaled, so pharmaceutical companies have to repeat the same process thousands of times to make a small amount of therapeutics.
An Automated Solution for Cell Therapy
Cellares’ solution is to make a completely closed and automated process from end-to-end for cell therapy that even includes the automated generation of documents. Cellares’ Cell Shuttle, what the company calls a “factory in a box,” allows a team to upload the cellular starting material from a patient or donor and end with a product that is ready for testing, freezing, and shipping to the patient.
“The entire manufacturing process, including enrichment, isolation, activation, gene transfer using either viral vectors or electroporation, expansion, filling, finishing, and formulation, is automated. This is true walk-away, end-to-end automation that makes the process scalable,” says Gerlinghaus.
The Cell Shuttle is the size of a conference room or a small pickup truck and maintains its own cleanroom environment with a robotic workcell. You can load up to 10 cartridges into the Cell Shuttle and run 10 processes simultaneously. You can configure the instruments in the shuttle to customize them.
“By automating the process and effectively reducing the amount of human labor that is required, we are confident we can reduce the price point of these cell therapies by up to 70% and lower the risk of process failure by a factor of three,” says Gerlinghaus.
Automating the process is also important from the perspective of the talent shortage that the cell therapy industry is facing today. A drug that 10,000 patients need per year requires about 1,000 employees in manufacturing. Cellares’ solution only needs about 250 employees in manufacturing to make 10,000 patient doses.
Scaling cell therapy technology will allow 50,000 or 100,000 patients per year to receive the drugs they need. The U.S. Food and Drug Administration (FDA) projects that there will be 10 to 20 new cell therapies every year starting in 2025. Cellares believes hundreds of cell therapies can be manufactured on its equipment that can save millions of lives.
Cell therapy promises to provide cures for devastating cancers. Scaling the necessary technology is the first step in making this a reality.
Thank you to Lana Bandoim for additional research and reporting in this article. I’m the founder of SynBioBeta, and some of the companies that I write about are sponsors of the SynBioBeta conference and weekly digest.