Cell therapy is a relatively new concept in the world of modern medicine. Following its commercial debut in 2017 and 2018 in the United States and Europe respectively, it has proven to have great potential in the fight to find cures for many diseases.
Currently however, the main focus is on the treatment of cancer. There are over 250 clinical trials studying autologous chimeric antigen receptor (CAR) T-cell therapies worldwide.
Most research and trials are being aimed at liquid (or blood) cancers like leukaemia and lymphoma but plans are in place to begin trials on solid cancers like pancreatic cancer, i.e. where an abnormal growth is present.
This article aims to shine a light on this flourishing area of medical research, giving an overview of what exactly cell therapy is and the difficulties faced during the manufacturing process.
What is Cell Therapy?
When we think about treatments for cancer, the most common treatment that comes to mind would usually be invasive surgery or chemotherapy, or perhaps even targeted drugs.
The introduction of cell therapy aims to revolutionise these treatments that cause many negative side effects in the patients. Cell therapies are made from “whole” cells. CAR T-cell immunotherapy is special as it works to boost the patient’s immune system by pre-programming the immune cells with the necessary information so that they themselves can attack cancerous cells in the body.
There are two types of cell transplants. Autologous cell transplants come from the same person who will eventually get the transplant. On the other hand, allogeneic cell transplants come from a person other than the patient.
What is Cell Therapy Manufacturing?
Cell therapy manufacturing involves the creation of different types of autologous and allogeneic cell therapies.
The autologous therapy must undergo a rapid manufacturing process so that it can be returned to the patient as quickly as possible.
On the other hand, allogeneic therapies can be manufactured and stored for future use.
For both processes, blood is retrieved from the cryobank. The cells are engineered and grown in a cleanroom lab. T cells, or white blood cells, are filtered from a patient’s blood and a new gene, or receptor is introduced into those cells.
This new gene programs the T cells to create a chimeric antigen receptor (CAR). This allows them to spot a protein that is present in cancer cells. These CAR T cells are then transferred to a growth medium. The number of cells is counted throughout the process, which can create enough cells for a single dose for an autologous therapy or potentially hundreds of doses for an allogeneic therapy.
The cells are placed in an incubator for multiple weeks where they continue to divide and multiply. After incubation, the cell therapies are transferred to vials for preparation for delivery to the clinical setting. Lastly, the cells are washed, harvested, concentrated and formulated into the final dose. This dose can be returned to the cryo-bank for long-term storage or in a cryo-shipper for delivery back to the patient.
The Road Ahead
Being a new therapy with extremely precise manufacturing needs, it’s no wonder that there are some challenges facing the supply chain of cell therapies.
As clinical trials and development went ahead at such a rapid pace, there was little time in the beginning for industrialised manufacturing considerations. As the commercial product was introduced first, we have seen manufacturing issues such as a lack of automation and a supply chain that is not mature.
What differentiates the cell therapy field from pharmaceutical manufacturing as we know it is the inclusion of the collection of cells from the patient and the dozens of hand-off points and processes that take place before the final administration of the product.
A successful supply chain must understand the whole process from beginning to end. The critical hand-offs, as well as the risks for each step, must be understood by the manufacturer. Due to the fact that autologous cell therapies are so personalised and have a single batch size, it is of utmost importance that the chain of custody and identity be maintained throughout the entire manufacturing process.
Contract manufacturing organisations (CMOs) are working to help with this challenge. They provide drug development and drug manufacturing services in the pharmaceutical industry on a contract basis. This frees up time and resources for the all-important trials to continue and can also help with scalability.
As cell therapy is developing so quickly, the need for contract manufacturing organisation cell therapy is increasing day by day.
